YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha .eiÜ...

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wxl 2144$20 - 2019 Tlaf;dan¾ ui 09 jeks nodod - 2019'10'09 No. 2144/20 - WEDNESDAY, OCTOBER 9, 2019 YS % ,xld m% cd;dka ;s % l iudcjd§ ckrcfha .eiÜ m;% h w;s úfYI (Published by Authority) PART I : SECTION (I) — GENERAL Government Notifications The Gazette of the Democratic Socialist Republic of Sri Lanka EXTRAORDINARY This Gazette Extraordinary can be downloaded from www.documents.gov.lk 1A—PG 4679 - 257 (10/2019) Order No. 01 NATIONAL MEDICINES REGULATORY AUTHORITY ACT, NO. 5 OF 2015 Order under section 60 (2) BY VIRTUE of the powers vested in me by section 60 (2) of the National Medicines Regulatory Authority Act, No. 5 of 2015, I, Prof. Asita De Silva, Chairman of the National Medicines Regulatory Authority, do by this Order, inform the public that the medicines specified in the Schedules here to have been registered with the National Medicines Regulatory Authority. Prof. ASITA DE SILVA Chairman, (For and on behalf of) National Medicines Regulatory Authority Colombo August 8, 2019

Transcript of YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha .eiÜ...

  • wxl 2144$20 - 2019 Tlaf;dan¾ ui 09 jeks nodod - 2019'10'09No. 2144/20 - WEDNESDAY, OCTOBER 9, 2019

    YS% ,xld m%cd;dka;s%l iudcjd§ ckrcfha .eiÜ m;%hw;s úfYI

    (Published by Authority)

    PART I : SECTION (I) — GENERALGovernment Notifi cations

    The Gazette of the Democratic Socialist Republic of Sri LankaEXTRAORDINARY

    This Gazette Extraordinary can be downloaded from www.documents.gov.lk1A—PG 4679 - 257 (10/2019)

    Order No. 01

    NATIONAL MEDICINES REGULATORY AUTHORITY ACT, NO. 5 OF 2015

    Order under section 60 (2)

    BY VIRTUE of the powers vested in me by section 60 (2) of the National Medicines Regulatory Authority Act, No. 5 of 2015, I, Prof. Asita De Silva, Chairman of the National Medicines Regulatory Authority, do by this Order, inform the public that the medicines specifi ed in the Schedules here to have been registered with the National Medicines Regulatory Authority.

    Prof. ASITA DE SILVAChairman,

    (For and on behalf of) National Medicines Regulatory Authority

    Colombo August 8, 2019

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    SCHEDULE - I

    COLUMN-I COLUMN-II COLUMN-III

    COLUMN-IV COLUMN-V COLUMN-VI

    COL-UMN-VII

    COL-UMN-VIII

    Offi cial Name Brand Name Dosage Form

    Importer Name

    Manufacturer Man-Country

    Issue Date

    Reg. Type

    1 BENZALKONIUM CHLORIDE,CETRIMID 0.01%,0.2% DRAPOLENE CREAM GlaxoSmithkiline Pharmaceuti clas (Pvt) Ltd

    Glaxo Smithkiline Pharmaceuti clas

    POLAND 24-Mar-14

    Full

    2 CHLORHEXIDINE GLUCONATE 2.5%+ISOPROPYL ALEOHOL BP 70%

    SANISCUB C SOLUTION Ceyoka (Pvt) Ltd Sirmaxo Chemicals Pvt Ltd

    INDIA 07-Jan-15 Full

    3 CHLOROXYLENOL LIQUID 4.8% APPLICATION DETTOL LIQUID N/A CDDEF Manu-facturers & Mer-chants for Rekitt Benkiser

    SRI LANKA 01-Jan-18 Provisional

    4 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES

    STREPSILS HONEY & LEMON

    LOZENGES Reckitt Benckiser (Lanka) Ltd

    Reckitt Benckser Healthcare

    THAILAND 28-Apr-15 Full

    5 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES

    STREPSILS COOL LOZENGES Reckitt Benckiser (Lanka) Ltd

    Reckitt Benckiser Healthcare UK Ltd

    THAILAND 28-Apr-15 Full

    6 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES

    STREPSILS ORIGINAL

    LOZENGES Reckitt Benckiser (Lanka) Ltd

    Reckitt Benckser Healthcare

    THAILAND 28-Apr-16 Full

    7 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES

    THERASIL LOZENGES George Steuart Health (Pvt) Ltd

    Plethico Pharma-ceuti cals Ltd

    INDIA 05-Apr-15 Full

    8 GLIPE MIXTURE WITH OIL OF AMITHI B PBCO 1% SODIUM BICARBONATE 1.0% & ZIMGIBAR OFFICINALE (GINGER) EXTRACT 0.48% FOR CHILDREN 4

    MORISON S GRIPE MIXTURE

    SYRUP N/A M S J Industries (Ceylon) (Pvt) Ltd

    SRI LANKA 14-Jun-17 Two Years

    9 INFANT CARMINATIVE SYRUP OIL OF ANETHI BPC 0.1% SODIUM BICARBONATE BP 1%

    MORISON S GRIPE MIXTURE

    SYRUP N/A M S J Industries (Ceylon) (Pvt) Ltd

    SRI LANKA 19-Oct-14 Full

    10 INFANT CARMINATIVE SYRUP SODIUM BICARBONATE +DIL OIL BP 0.1%

    GAMMA'S GRIPE MIXTURE

    MIXTURE N/A Gamma Pharma-ceuti cals Pvt Ltd

    SRI LANKA 16-May-14

    Full

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    11 METHYL SALICYLATE 10.2% + MENTHOL 5.44% + EUGENOL 1.36%

    FLANIL CREAM George Steuart Health (Pvt) Ltd

    Biolab Co Ltd THAILAND 24-May-14

    Full

    12 METHYL SALICYLATE 6.3% ,MENTHOL 5.7% ,CAMPHAOR 1. 2% & TOCOPHEROL ACETATE

    SALONPAS PATCH Akbar Pharmaceuti cals (Pvt) Ltd

    Hisamitsu Phar-maceuti cals Co Inc

    JAPAN 06-Apr-15 Full

    13 METHYL SALICYLATE 6.3% ,MENTHOL 5.7% ,CAMPHAOR 1. 2% & TOCOPHEROL ACETATE

    SALONPAS PATCH Akbar Pharmaceuti cals (Pvt) Ltd

    Hisamitsu Pharmaceuti cals Co Inc

    JAPAN 06-Apr-15 Full

    14 METHYL SALICYLATE COMPOUND GEL WINTERPAN GEL N/A Akbar Pharmaceuti cals (Pvt) Ltd

    SRI LANKA 11-Apr-14 Full

    15 ORAL REHYDRATION SALTS BP 21.5G MINERVA ORAL POWDER

    Emar Pharma (Pvt) Ltd

    Unicure Ramadies (Pvt) Ltd

    INDIA 04-Jun-16 Full

    16 PARACETAMOL (PAEDIATIC) ORAL SOLUTION B.P 120MG/5ML

    PARACETOL LIQUID N/A Gamma Pharmaceuti cals Pvt Ltd

    SRI LANKA 22-Oct-14 Full

    17 PARACETAMOL (PAEDRIATIC) ORAL SOLUTION B.P 120MG/5ML

    PANADOL SYRUP

    SYRUP N/A Glaxo Wellcome (Ceylon) Ltd

    SRI LANKA 16-Jun-18 Full

    18 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P 120MG/5ML-Elixir

    ***** ORAL SOLUTION

    N/A M S J Industries (Ceylon) (Pvt) Ltd

    SRI LANKA 08-Feb-18 Two Years

    19 PARACETAMOL TABLETS 500MG PANADOL TABLETS N/A Smithkline Beecham (Pvt) Ltd

    SRI LANKA 17-Oct-16 Full

    20 PARACETAMOL TABLETS BP 500MG ACETAMIN TABLETS Citi health Imports (Pvt) Ltd

    Incepta Pharmaceuti cals Ltd

    15-Aug-17 Two Years

    21 PARACETAMOL TABLETS BP 500MG MAXMOL TABLETS George Steuart Health (Pvt) Ltd

    Shefa Healthcare (Pvt) ltd

    INDIA 18-Jan-14 Full

    22 PARACETAMOL TABLETS BP 500MG RAPISOL TABLETS N/A Astron (Pvt) Ltd SRI LANKA 13-Nov-15 Full

    23 PEDIATRIC PARACETAMOL ORAL SOLUTION B.P 120MG/5ML

    MAXMOL ORAL SUSPENSION

    George Steuart Health (Pvt) Ltd

    Shefa Healthcare (Pvt) ltd

    INDIA 10-Jun-15 Full

    SCHEDULE - I

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    SCHEDULE - II (GROUP A) (Contd.)

    COLUMN-I COLUMN-II COLUMN-III COLUMN-IV COLUMN-V COLUMN-VI

    COLUMN-VII

    COLUMN-VIII

    Offi cial Name Brand Name Dosage Form Importer Name Manufacturer Man-Country

    Issue Date Reg. Type

    1 ALBENDAZOLE TABLETS USP 400MG ALBEZIM TABLETS Tabrane Phar-maceuticals (Pvt) Ltd

    Zim Laboratories Ltd

    INDIA 03-Oct-14 Full

    2 ALUM.HYDR. DRIED GEL 300MG+MAG.ALUM.SILICATE HYDR 50MG+MAG.HYDR. 25MG SIMETHICONE 25MG

    DIGENE MINT FLAVOUR

    TABLETS Sunshine Healthcare lanka Ltd

    Abbott India Ltd INDIA 01-Jan-18 Provisional

    3 ALUM.HYDR.306MG+MAG.HYDR 100MG+SIMETHICONE 25MG/5ML

    VISCID ORAL SUSPENSION

    Hemas Pharma-ceuticals (Pvt) Ltd

    Indoco Remedies India

    INDIA 18-Jan-17 Full

    4 ALUM.HYDR.GEL 400MG+MAG.HYDR 400MG+SIMETHICONE 50MG/5ML

    ANTAGTT DS ORAL SUSPENSION

    Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd

    INDIA 28-May-14 Full

    5 ALUMINIUM +MAGNESIUM & SIMETHICONE TABLETS USP (LEMON Flavour)

    GASTRIL-LEMON

    TABLETS Inter Pharm (Pvt) Ltd

    Inter Pharm (Pvt) Ltd

    SRI LANKA 27-Sep-17 Full

    6 ALUMINIUM +MAGNESIUM & SIMETHICONE TABLETS USP (Mint Flavour)

    GASTRIL-MINT TABLETS Inter Pharm (Pvt) Ltd

    SRI LANKA 27-Sep-15 Full

    7 ALUMINIUM 400MG+MAGNESIUM 400MG)HYDROXIDE+SIMETHICONE 50MG

    ANTAGIT TABLETS Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd

    INDIA 02-Mar-14 Full

    8 ALUMINIUM HYD.GEL. BP 200MG+MAGNESIUM HYD.100MG+MAGNESIUM TRISLICATE BP 200MG+SODIUM ALGINATE BP 100MG

    CATOXYMAG-N ORAL SUSPENSION

    Pharma Associates

    Raptakos Brett & Company Ltd

    INDIA 05-Dec-14 Full

    9 ALUMINIUM HYDROXIDE 8OOMG+MAGNESIUM HYDROXIDE 800MG+SIMETHICONE

    ZELLOX -11 ORAL SUSPENSION

    Indoscan (Pvt) Ltd

    Hoe Pharmaceuticals SDN BHD

    MALAYSIA 28-May-14 Full

    10 ALUMINIUM HYDROXIDE 960MG+MAGNESIUM HYDROXIDE 330MG+ SIMETHICONE 60MG

    ANTACIL GEL GEL Sonali & Sudesh Thai Nakorn Patana Co Ltd

    THAILAND 19-Aug-15 Full

    11 ALUMINIUM HYDROXIDE B.P 500MG ***** CHEWABLE TABLETS

    State Phar-maceuticals Manufacturer Corporation

    State Pharmaceuticals Manufacturer Corporation

    SRI LANKA 22-Dec-14 Full

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    SCHEDULE - II (GROUP A) (Contd.)

    12 ALUMINIUM HYDROXIDE B.P 500MG **** TABLETS Kamazu (Pvt) Ltd

    B D H Industries Ltd

    INDIA 07-Nov-14 Full

    13 ALUMINIUM HYDROXIDE GEL 918MG+MAGNESIUM HYDROXIDE 300MG+ SIMETHICONE 60MG

    BELCID ORAL SUSPENSION

    George Steuart Health (Pvt) Ltd

    Biolab Co Ltd THAILAND 15-Oct-18 Full

    14 ALUMINIUM oxide 570MG+MAGNESIUM hydrox 300MG & SIMETHICONE 60MG ORAL SUSPENSION USP

    ADMAG ORAL SUSPENSION

    Medinex (Pvt) Ltd

    T P Drugs Laboratories

    THAILAND 07-Dec-14 Full

    15 ALUMINUM HYDROXIDE DRIED GEL 500MG,MAGNESIUM TRISILICATE 240MG +MAGNESIUM HYDROXIDE 240MG IN10ML

    GASTROGEL ORAL SUSPENSION

    Sonali & Sudesh Aspen Pharma (Pvt) Ltd

    AUSTRA-LIA

    08-May-16 Full

    16 AQUEOUS CREAM WITH GLYCERINE D-AQUA CREAM Panacea Medicals

    Panacea Medicals

    SRI LANKA 01-Jun-17 Two Years

    17 AQUEOUS CREAM WITH GLYCERINE D-SOFT CREAM CREAM Panacea Medicals

    Panacea Medicals

    SRI LANKA 25-Apr-17 Two Years

    18 AQUEOUS CREAM WITH GLYCERINE 2% AQUARIN CREAM Panacea Medicals

    Panacea Medicals

    SRI LANKA 27-Jun-17 Two Years

    19 ASCORBIC ACID TABLETS BP 100MG C-TABS TABLETS Unical Ceylon (Pvt) Ltd

    Unical Ceylon (Pvt) Ltd

    SRI LANKA 18-Jul-16 Full

    20 ASCORBIC ACID TABLETS BP 100MG ***** TABLETS Inter Pharm (Pvt) Ltd

    Inter Pharm (Pvt) Ltd

    SRI LANKA 11-May-17 Two Years

    21 ASCORBIC ACID TABLETS BP 100MG ***** TABLETS M S J Industries (Ceylon) (Pvt) Ltd

    M S J Industries (Ceylon) (Pvt) Ltd

    SRI LANKA 01-Jan-17 Full

    22 ASCORBIC ACID TABLETS BP 250MG CHEWCE TABLETS Darley Butler & Co Ltd

    Navana Pharmaceuticals Ltd

    BANGLA-DESH

    30-Nov-16 Full

    23 ASCORBIC AICD CHEWABLE TABLETS USP 100MG

    SHINE Vit. C 100 TABLETS Y S P Lanka (Pvt) Ltd

    l(Pvt) Ltd.

    Y S P Industries /SDN BHD

    MALAYSIA 30-Apr-17 Full

    24 ASPIRIN GASTRO RESISTANT TABLETS BP 75MG

    CARVA TABLETS (EN.COA.)

    PharmAce (Pvt) Ltd

    Square Pharmaceuticals Ltd

    BANGLA-DESH

    27-Nov-14 Full

    25 CALAMINE BP 4%+WITCH HAZEL BPC 5%+PHENOL 0.2%+SODIUM BENZOATE 0.1%

    CALAMINE LOTION

    LOTION M S J Industries (Ceylon) (Pvt) Ltd

    SRI LANKA 29-Oct-15 Full

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    SCHEDULE - II (GROUP A) (Contd.)

    26 CALCIUM CARBONATE 1500MG +VIT. D3 200IU(Equivalent to calcium 600mg)

    CALCIVITA FORTE

    SOFT GELETIN CAPSULES

    A Baur & Co (Pvt) Ltd

    Mega Lifesciences (Pvt) Ltd

    THAILAND 24-Feb-14 Full

    27 CALCIUM CARBONATE TABLETS USP 1250MG

    ROCAL TABLETS Citihealth Imports (Pvt) Ltd

    Healthcare Pharmaceuticals

    18-Aug-16 Full

    28 CHLORHEXIDINE GLUCONATE 2% MOUTHWASH

    CLINICA MOUTH WASH CIC Holdings PLC

    Platinum Pharmaceuticals (Pvt) Ltd

    PAKISTAN 03-Feb-18 Full

    29 CHLORHEXIDINE DIAGLUCONATE MOUTHWASH 0.2% W/V

    CORSODYL MINT

    MOUTH WASH-SOLUTION

    Glaxo Wellcome (Ceylon) Ltd

    Glaxo Wellcome (Ceylon) Ltd

    SRI LANKA 15-Feb-17 Full

    30 CHLORHEXIDINE GLUCONATE 1.5% CETRIMIDE 15%

    **** SOLUTION M S J Industries (Ceylon) (Pvt) Ltd

    M S J Industries (Ceylon) (Pvt) Ltd

    SRI LANKA 01-Jan-17 Full

    31 CHLORHEXIDINE GLUCONATE GEL 1.0%W/W HEXIGEL COLLAPSIBLE TUBES

    George Steuart Health (Pvt) Ltd

    ICPA Health Products Ltd

    INDIA 06-Feb-14 Full

    32 CHLORPHENAMINE ORAL SOLUTION BP 2ML/5ML (CHLORPHENIRAMINE)

    CHLOFEN ORAL SOLUTION

    Inter Pharm (Pvt) Ltd

    Inter Pharm (Pvt) Ltd

    SRI LANKA 11-Feb-15 Full

    33 CHLORPHENIRAMINE MALEATE 2MG/5ML SYRUP

    PIRITON SYRUP Glaxo Wellcome (Ceylon) Ltd

    Glaxo Wellcome (Ceylon) Ltd

    SRI LANKA 16-Mar-17 Full

    34 CONTAINING LIQUID EXTRACT OF GLYCERRHI 4%,LIQUID EXTRACT OF COCILLANE 1% MENTHOL 0.05%

    VALMELIX SYRUP M S J Industries (Ceylon) (Pvt) Ltd

    M S J Industries (Ceylon) (Pvt) Ltd

    SRI LANKA 01-Jan-18 Two Years

    35 CYANOCOBALAMINE (VITAMIN B12, 35MCG/5ML SYRUP

    CYTACON SYRUP Glaxo Wellcome (Ceylon) Ltd

    Glaxo Wellcome (Ceylon) Ltd

    SRI LANKA 12-Sep-17 Two Years

    36 DEQUALINIUM CHLORIDE LOZENGES 0.25MG

    DEXXON LOZENGES Delmege Forsyth & Co Ltd

    Kotra pharma (M) Ltd

    MALAYSIA 26-Apr-18 Full

    37 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES

    SUPERIL LOZENGES (ORANGE)

    LOZENGES George Steuart Health (Pvt) Ltd

    Unique Pharmaceutical Labs

    INDIA 08-May-15 Full

    38 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES

    SUPERIL LOZENGES George Steuart Health (Pvt) Ltd

    Unique Pharmaceutical Labs

    INDIA 08-May-15 Full

    39 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ LOZENGES

    SUPERIL LOZENGES (LEMON)

    LOZENGES George Steuart Health (Pvt) Ltd

    Unique Pharmaceutucal Laboratories

    INDIA 28-May-15 Full

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    SCHEDULE - II (GROUP A) (Contd.)

    40 DICHLOROBENZYL ALCOHOL 1.2mg (2,4)+AMYLMETACRESOL 0.6m+ VITAMIN C 100mg LOZENGES

    STREPSILS ORIGINAL

    LOZENGES Reckitt Benckiser (Lanka) Ltd

    Reckitt Benckser Healthcare

    THAILAND 28-Apr-15 Full

    41 DICLOFENAC GEL BP 1% DICLOMOL GEL Robert Hall & Co Ltd

    G S Pharmabutor (Pvt) Ltd

    INDIA 13-Jul-18 Full

    42 DIMETHICONE 50MG ACTIVATED+MAGNESIUM HYDROXIDE 250MG+ALUMINIUM HYDROXIDE 250MG

    DIGUSIL MPS ORAL SUSPENSION

    Breathe Free Lanka (Pvt) Ltd

    Cipla Ltd INDIA 21-Jul-18 Two Years

    43 DRIED ALUM.HYDROX.GEL 250MG,MAGNE HYDRA 250MG+SIMETHICONE 50MG

    ACIFREE SUSPENSION Sunshine Healthcare lanka Ltd

    Sai Mirra Innopharm (Pvt) Ltd

    INDIA 19-Nov-14 Full

    44 DRIED ALUMINIUM HYDROXIDE 400MG+DRIED MAGNESIUM HYDROXIDE 400MG

    AGIFLUX CHEWABLE TABLETS

    Citihealth Imports (Pvt) Ltd

    Agio Pharmaceuticals Ltd

    INDIA 03-Nov-16 Full

    45 DRIED ALUMINIUM HYDROXIDE GEL 300MG,MAGNESIUM HYDROXIDE SILICATE HYDRATE 50MG+MAGNESIUM HYDROXIDE 25MG, SIMETHICONE 25MG CHEWABLE TABLETS

    DIGENE MIXED FRUIT FLAVOUR

    CHEWABLE TABLETS

    Sunshine Healthcare lanka Ltd

    Abbott India Ltd INDIA 21-Jul-15 Full

    46 FERROUS GLYCINE SULPHATE EQUIVALENT TO 60MG,NIACINAMIDE BP 50MG+PYRIDOXINE HYDROCHLORIDE BP 3MG,CYANOCABALAMINE BP 15MG +FOLIC ACID 1MG+ZINC SULPHATE BP ZINC 5

    FERIGEN XT SUGAR COATED TABLETS

    Lifeline Pharmaceuticals (Pvt) Ltd

    Nem Laboretories (P) Ltd

    INDIA 29-May-18 Full

    47 FERROUS SULPHATE 150MG+FOLIC ACID 500MCG

    FEFOL CAPSULES A Baur & Co (Pvt) Ltd

    The United Pharmaceutica Manufacturer

    JORDAN 07-Aug-16 Full

    48 FISH OIL CONCENTRATED SOFT GELATINE CAPSULES 1000MG

    MAXX OMEGA 3 SOFT GELETIN CAPSULES

    A Baur & Co (Pvt) Ltd

    Mega Lifesciences Public Company (Pvt) Ltd

    THAILAND 24-Mar-14 Full

    49 FOLIC ACID TABLETS BP 1MG **** TABLETS Inter Pharm (Pvt) Ltd

    Inter Pharm (Pvt) Ltd

    SRI LANKA 14-Oct-14 Full

    50 FOLIC ACID TABLETS BP 1MG F-A-One TABLETS Markss HLC (Pvt) Ltd

    MMC Healthcare Ltd

    INDIA 12-Jan-18 Two Years

    51 IRON & B COMPLEX FERRA B SYRUP Glaxo Wellcome (Ceylon) Ltd

    Glaxo Wellcome (Ceylon) Ltd

    SRI LANKA 02-Dec-17 Full

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    8

    SCHEDULE - II (GROUP A) (Contd.)

    52 IRON & VITAMIN ZINCOFER LIQUID A Baur & Co (Pvt) Ltd

    Apex Laboratories Ltd

    INDIA 29-Oct-14 Full

    53 IRON (III) HYDROXIDE POLYMALTOSE 100MG+FOLIC ACID CHEWABLE TABLETS 0.35MG

    RBC-F CHEWABLE TABLETS

    Ceyoka (Pvt) Ltd Genix Pharma (Pvt ) Ltd

    PAKISTAN 23-Apr-14 Full

    54 IRON (III) HYDROXIDE POLYMALTOSE COMPLEX SYRUP 50MG/5ML

    RBC Syrup SYRUP Ceyoka (Pvt) Ltd Genix Pharma (Pvt ) Ltd

    PAKISTAN 02-Jun-15 Full

    55 IRON WITH FOLIC ACID VIT.C & VIT. B COMPLEX

    DUMASULES CAPSULES Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 24-Sep-16 Full

    56 IRON+ VITAMIN B OMPLEX CAPSULES SANGOBION CAPSULES Emerchemie NB (Ceylon) Ltd

    Martin Daw Pharmaceuticals Ltd

    PAKISTAN 23-Oct-16 Two Years

    57 IRON+ VITAMIN B OMPLEX CAPSULES SANGOBION CAPSULES Emerchemie NB (Ceylon) Ltd

    Merck (Pvt) Ltd PAKISTAN 23-Oct-16 Two Years

    58 ISPAGHULA HUSK I.P 4.8G/5G W/W CREMADIET POWDER CIC Holdings PLC

    Tirupathi Medicare Ltd

    INDIA 29-Jul-16 Full

    59 ISPAGULAR HUSK GRANULES BP 3.75G/4.8G FIBEREX GRANULES SMM Halcyon (Pvt) Ltd

    Meyer Organics (Pvt) Ltd

    INDIA 20-Oct-14 Full

    60 KETOPROFEN GEL 2.5% (KETOPROFEN 2.5% W/W ,METHYL SALICYLATE 8.5% W/W MENTHOL 4% W/W)

    RELEEV GEL Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 09-Oct-17 Two Years

    61 LEVONORGESTREL TABLETS 0.75MG MADONNA TABLETS George Steuart Health (Pvt) Ltd

    Biolab Co Ltd THAILAND 20-Aug-18 Two Years

    62 LEVONORGESTREL TABLETS 0.75MG POSTINOR TABLETS The Family fl anning associatio

    Gedeon Richter Ltd

    HUNGARY 28-Jan-15 Full

    63 LIGHT LIQUID PARAFFIN 6% + WHITE SOFT PARAFFIN 15% CREAM

    OILATUM CREAM

    CREAM Glaxo Wellcome (Ceylon) Ltd

    Glaxo Operations UK Ltd

    UNITED KINGDOM

    20-Sep-14 Full

    64 MAGNESIUM HYDROXIDE 185 SIMETHICONE 50MG,DRIED ALU.HYD GEL 830MG +CARBOXYMETHYLCELLULOSE 100MG/10ML ORAL SUSPENSION

    DIGENE GEL ORANGE FLAVOUR

    ORAL SUSPENSION

    Sunshine Healthcare lanka Ltd

    Abbott India Ltd INDIA 23-Mar-18 Full

    65 MAGNESIUM HYDROXIDE 185 SIMETHICONE 50MG,DRIED ALU.HYD GEL 830MG +CARBOXYMETHYLCELLULOSE 100MG/10ML ORAL SUSPENSION

    DIGENE MINT FLAVOUR- GEL

    ORAL LIQUID Sunshine Healthcare lanka Ltd

    Abbott India Ltd INDIA 16-May-18 Full

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    9

    SCHEDULE - II (GROUP A) (Contd.)

    66 MAGNESIUM HYDROXIDE IP 185 SIMETHICONE IP50MG,DRIED ALU.HYD GEL IP 830MG+CARBOXYMETHYL IP 100MG/10ML

    DIGENE GEL MIXED FRUIT FLAVOUR

    ORAL SUSPENSION

    Sunshine Healthcare lanka Ltd

    Abbott India Ltd INDIA 23-Mar-18 Full

    67 MANGESIUM TRISILICATE 350+ DRIED ALUMINIUM HYDROXIDE GEL 250MG +KAOLIN

    ANTACIL TABLETS Sonali & Sudesh Thai Nakorn Patana Co Ltd

    THAILAND 16-Oct-15 Full

    68 MEBENDAZOLE ORAL SUSPENSION USP 100MG/5ML

    AGOBEN ORAL SOLUTION

    lifeServ (Pvt) Ltd Agog Pharma Ltd INDIA 04-May-14 Full

    69 MEBENDAZOLE TABLETS 500MG BENHOL 500 CHEWABLE TABLETS

    Kalpentyn Syndicats (Pvt) Ltd

    Pure pharma Ltd INDIA 04-Jun-16 Full

    70 MEBENDAZOLE TABLETS U.S.P 100MG MEBFIL TABLETS Sunshine Healthcare lanka Ltd

    Fourrts (India) Laboratories Ltd

    INDIA 11-Feb-18 Two Years

    71 MEBENDAZOLE TABLETS U.S.P 100MG MEBFIL TABLETS Sunshine Healthcare lanka Ltd

    Fourrts (India) Laboratories Ltd

    INDIA 11-Feb-18 Two Years

    72 MEBENDAZOLE TABLETS U.S.P 500MG ***** TABLETS Chamee Chemist

    Bajaj Healthcare Ltd

    INDIA 20-Jun-14 Full

    73 METHYL SALICYLATE 12.5%,MENTHOL 3%, THYMOL 10.5%,EUCALYPTUS OIL 0.5%,CAPSIUM 0.5%

    TRANSPAIN CREAM

    CREAM Panacea Medicals

    Panacea Medicals

    SRI LANKA 27-Jun-17 Full

    74 METHYL SALICYLATE 2% ,MENTHOL 5% ,CAMPHAOR 2%

    SALONPAS SPRAY

    AEROSOL SPRAY

    Akbar Pharmaceuticals (Pvt) Ltd

    Hisamitsu Pharmaceuticals Co Inc

    JAPAN 14-Mar-14 Full

    75 METHYL SALICYLATE AEROSOL 60G WINSPAY 60 AEROSOL SPRAY

    Emerchemie NB (Ceylon) Ltd

    Shandong Jewim Pharmaceutical Co. Ltd

    CHINA 08-Mar-14 Full

    76 METHYL SALICYLATE BP 8% ,MEPHENESIN BPC 5%,METHYL NICOTANATE BP 1% MENTHOL USP 2%W/W CREAM

    FLAMAR CREAM Hemas Pharmaceuticals (Pvt) Ltd

    Indoco Remedies India

    INDIA 08-Aug-16 Full

    77 METHYL SALICYLATE COMPOUND CREAM METHYL SALICYLATE 12.5% MENTHOL 2.5%,OLEORESIN CAPSICUM 0.25, THYMOL 0.12% EUCALYPTUS OIL 0.2%

    WINCREAM CREAM Falcon Pharmaceuticals (Pvt) Ltd

    Falcon Pharmaceuticals (Pvt) Ltd

    SRI LANKA 13-Sep-17 Two Years

    78 METHYL SALICYLATE OINTMENT RELAXON PLUS OINTMENT Neon Pharmaceuticals (Pvt) Ltd

    Neon Pharmaceuticals (Pvt) Ltd

    SRI LANKA 23-Jun-16 Full

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    10SCHEDULE - II (GROUP A) (Contd.)

    79 METHYL SALUCYLATE,COMPOUND OINTMENT METHYL SALICYLATE MENTHOL 2.2% EUCALYPTUS OIL 0.12%,THYMOL 0.12% ,CAMPHOR 1%

    PRINCE WINTERGREEN

    OINTMENT Prince Marketing Service

    Prince Marketing Service

    SRI LANKA 09-Oct-16 Full

    80 MULTIVITAMIN & MINERALS CAPSULES MINTERRA CAPSULES Astron (Pvt) Ltd SRI LANKA 11-Feb-15 Full

    81 MULTIVITAMIN & MINERALS CHEWABLE TABLETS

    VITA-KID CHEWABLE TABLETS

    Alaris Lanka (Pvt) Ltd

    Contract Manufacuring & Packging Services pty Ltd

    20-May-14 Full

    82 MULTIVITAMIN & MINERALS SOFT GELATIN CAPSULES VIT. A USP 1.5MG,VIT. D3, USP 0.4MG,VIT. B1 1.50MG,VIT. B2,1.70MG USP,VIT B6 2.00MG,VIT, CBP 60MG,NICOTI

    STANO-M CAPSULES Tabrane Healthcare (Pvt) Ltd

    Globe Pharmaceuticals Ltd

    24-Oct-15 Full

    83 MULTIVITAMIN & MINERALS TABLETS ONE A DAY TABLETS CCL Pharmaceuticals Lanka (Pvt) Ltd

    CCL Pharmaceuticals (Pvt) Ltd

    PAKISTAN 11-Mar-14 Full

    84 MULTIVITAMIN CAPSULES MULTIFORTE CAPSULES Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 20-May-16 Full

    85 MULTIVITAMIN SYRUP GROVIT SYRUP Hemas Pharmaceuticals (Pvt) Ltd

    U S V Ltd INDIA 25-Oct-15 Full

    86 MULTIVITAMIN SYRUP HOVITE SYRUP SYRUP Pharma Associates

    Raptakos Brett & Company Ltd

    INDIA 28-Jul-15 Full

    87 MULTIVITAMIN SYRUP VITALISE SYRUP Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 03-Feb-15 Full

    88 MULTIVITAMINS & MINERALS CAP GUARDIAN CAPSULES Sunshine Healthcare lanka Ltd

    Catalent Australia (Pvt) Ltd

    13-Oct-14 Full

    89 NEOMYCIN SULPHATE 5MG + BACITRACIN ZINC 500IU/G OINTMENT

    NEBANOL OINTMENT PharmAce (Pvt) Ltd

    Square Pharmaceuticals Ltd

    28-Jan-15 Full

    90 OMEGA 3 FISH OIL CAPSULES 1000MG SOLOMEGA SOFT GELETIN CAPSULES

    Alaris Lanka (Pvt) Ltd

    Contract Manufacuring & Packging Services pty Ltd

    20-May-14 Full

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    11

    SCHEDULE - II (GROUP A) (Contd.)

    91 OMEGA 3 FISH OIL SOFT GEL CAPSULS 750MG

    HAPPY KIDS SOFT GELETIN CAPSULES

    Alaris Lanka (Pvt) Ltd

    Contract Manufacuring & Packging Services pty Ltd

    27-Apr-15 Full

    92 ORAL REHYDRATION ELECTROLYTE SOLUTION ORANGE FLAVOUR

    PAEDICARE ORAL SOLUTION

    Markss HLC (Pvt) Ltd

    Woodward Pakitan (Pvt) Ltd

    PAKISTAN 14-Dec-17 Full

    93 ORAL REHYDRATION ELECTROLYTE SOLUTION ORANGE FLAVOUR

    PAEDICARE ORAL SOLUTION

    Markss HLC (Pvt) Ltd

    Woodward Pakitan (Pvt) Ltd

    PAKISTAN 14-Dec-17 Full

    94 ORAL REHYDRATION SALT IP PROLYTE POWDER Breathe Free Lanka (Pvt) Ltd

    Cipla Ltd INDIA 31-Jan-15 Full

    95 ORAL REHYDRATION SALTS BP (O.R.S) ORSAL POWDER Associated Laboratories (Pvt) Ltd

    Well & Well Pharma (Pvt) Ltd

    PAKISTAN 30-Mar-16 Full

    96 ORAL REHYDRATION SALTS FOR SOLUTION (SODIUM CHLORIDE 2.6G,POTASIUM CHLORIDE 1.5MG,DEXTROSE ANHYDROUS 12.5G)PEDITRAL (LOW OSMOLARITY- O.R.S)

    PEDITRAL LOW ORAL SOLUTION

    Morison PLC Searle-Pakistan PAKISTAN 09-Feb-15 Full

    97 ORAL REHYDRATION SOLUTION (FLAVOUR STRAWBERRY)

    PEEDICARE ORAL SOLUTION

    Markss HLC (Pvt) Ltd

    Woodward Pakistan (Pvt) Ltd

    PAKISTAN 10-Jun-16 Full

    98 PARACETAMOL (PAEDIATIC) ORAL SOLUTION B.P 120MG/5ML

    ARCET ORAL SOLUTION

    Pharma Associates

    Central drugs and Pharmaceutical

    INDIA 12-May-17 Two Years

    99 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P 120MG/5ML

    PARACIL SYRUP

    ORAL SOLUTION

    Sunshine Healthcare lanka Ltd

    Fourrts (India) Laboratories Ltd

    INDIA 05-Feb-15 Full

    100 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P 120MG/5ML

    ***** ORAL SOLUTION

    Chamee Chemist

    Gopaldas Visram & Co Ltd

    INDIA 16-Sep-14 Full

    101 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P 120MG/5ML

    PARAFIL ORAL SOLUTION

    Sunshine Healthcare lanka Ltd

    Fourrts (India) Laboratories Ltd

    INDIA 16-Aug-16 Full

    102 PARACETAMOL (PAEDRIATIC) ORAL SUSPENSION B.P 120MG/5ML

    ANODYNE-P ORAL SOLUTION

    Pharma Associates

    Bafna Pharmaceuticals Ltd

    INDIA 30-Apr-15 Full

    103 PARACETAMOL 120MG/5ML SYRUP CETAPYRIN SYRUP Glaxo Wellcome (Ceylon) Ltd

    Glaxo Wellcome (Ceylon) Ltd

    SRI LANKA 10-Feb-16 Full

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    12SCHEDULE - II (GROUP A) (Contd.)

    104 PARACETAMOL SYRUP USP 120MG/5ML RAPISOL SYRUP

    SYRUP Astron (Pvt) Ltd SRI LANKA 03-Feb-16 Full

    105 PARACETAMOL TABLETS BP 500MG PACETOL TABLETS ABC Pharma Services Pvt. Ltd

    Magbro Healthcare

    INDIA 28-Feb-18 Full

    106 PARACETAMOL TABLETS BP 500MG *** TABLETS Morison PLC Morison PLC SRI LANKA 16-Aug-18 Two Years

    107 PARACETAMOL TABLETS BP 500MG **** TABLETS P Jayanetti & Sons Pvt Ltd

    Kausikh Therapeutics (Pvt) Ltd

    INDIA 04-Jan-14 Full

    108 PARACETAMOL TABLETS BP 500MG ***** TABLETS Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 08-Oct-14 Full

    109 PARACETAMOL TABLETS BP 500MG AZICOT 500 TABLETS Alaris Lanka (Pvt) Ltd

    Scottish Pharma INDIA 28-Jun-14 Full

    110 PARACETAMOL TABLETS BP 500MG UNIMOL TABLETS Unical Ceylon (Pvt) Ltd

    Unical Ceylon (Pvt) Ltd

    SRI LANKA 18-Feb-16 Full

    111 PARACETAMOL TABLETS BP 500MG SPMC TABLETS State Pharmaceuticals Manufacturer Corporation

    State Pharmaceuticals Manufacturer Corporation

    SRI LANKA 06-Jun-16 Full

    112 PARACETAMOL TABLETS BP 500MG ASTAMOL TABLETS Associated Pharma Celyon (Pvt) Ltd

    Astamed Healthcare (Pvt) Ltd

    INDIA 28-Nov-14 Full

    113 PARACETAMOL TABLETS BP 500MG **** TABLETS SPMC/State Pharmaceuticals Manufacturing COP

    SPMC/State Pharmaceuticals Manufacturing COP

    INDIA 26-Apr-18 Provisional

    114 PARACETAMOL TABLETS BP 500MG ZIFAM TABLETS Alaris Lanka (Pvt) Ltd

    Adore Pharmaceuticals (Pvt) Ltd

    INDIA 23-Jun-17 Full

    115 PARACETAMOL TABLETS BP 500MG REGAMOL TABLETS Harcourts (Pvt) Ltd

    Bal Pharma Ltd INDIA 23-May-18 Two Years

    116 PARACETAMOL TABLETS BP 500MG KELVIN TABLETS Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd

    INDIA 17-Nov-17 Full

    117 PARACETAMOL TABLETS BP 500MG MEDMOL TABLETS Akbar Pharmaceuticals (Pvt) Ltd

    Medopharm (PVT Ltd

    INDIA 20-Oct-17 Two Years

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    13

    SCHEDULE - II (GROUP A) (Contd.)

    118 PERMETHRIN CREAM 5% W/W GLENPER CREAM Sunshine Healthcare lanka Ltd

    Glenmark Pharmaceuticals Ltd

    INDIA 11-Sep-18 Two Years

    119 PERMETHRIN HEAD LOTION 0.5% W/V LYCINE LOTION M W L De Silva & Co

    M W L De Silva & Co

    SRI LANKA 07-Jun-15 Full

    120 PERMETHRIN LOTION 2% W/V (A-Scaba) A-SCABS LOTION Indoscan (Pvt) Ltd

    Hoe Pharmaceuticals SDN BHD

    MALAYSIA 24-Oct-17 Full

    121 POLYETHYLENE GLYCOL 59.0G,SODIUM SULPHATE 5.685G SODIUM BICA

    KLEAN PREP POWDER ORAL SOLUTION

    Hemas Pharmaceuticals (Pvt) Ltd

    Helsinn Birex Pharmaceuticals Ltd

    IRELAND 11-Jun-18 Two Years

    122 POVIDONE IODINE 10% TOPICAL SOLUTION NOVASEPT TOPICAL SOLUTION

    ABC Pharma Services Pvt. Ltd

    Navketan Research & Labo. (Pvt) Ltd

    INDIA 23-Jul-15 Full

    123 POVIDONE IODINE 10% TOPICAL SOLUTION USP

    APODINE Solution

    SOLUTION Tabrane Healthcare (Pvt) Ltd

    Globe Pharmaceuticals Ltd

    28-Feb-14 Full

    124 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%

    SANIQUAD PVP 7.5%

    SOLUTION Ceyoka (Pvt) Ltd Sirmaxo Chemicals (Pvt) Ltd

    INDIA 13-Jul-15 Full

    125 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%

    NOVASEPT SURGICAL SCRUB

    ABC Pharma Services Pvt. Ltd

    Nawketan Resarch & Laboratories

    INDIA 24-Jul-15 Full

    126 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%

    SETADINE TOPICAL CREAM

    Suraksa Pharma (Pvt) Ltd

    Suraksa Pharma (Pvt) Ltd

    SRI LANKA 06-Apr-18 Full

    127 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%

    BETADINE SURGICAL SCRUB

    SOLUTION Robert Hall & Co Ltd

    G S Pharmabutor (Pvt) Ltd

    INDIA 05-Nov-17 Full

    128 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%

    PYODINE SOLUTION Hemas Pharma-ceuticals (Pvt) Ltd

    Brookes Pharma (Pvt) Ltd

    PAKISTAN 02-Jan-16 Full

    129 POVIDONE IODINE CLEANSING SOLUTION USP 7.5%

    BETADINE SURGICAL SCRUB

    SOLUTION Robert Hall & Co Ltd

    G S Pharmabutor (Pvt) Ltd

    INDIA 05-Nov-17 Full

    130 POVIDONE IODINE OINTMENT USP 5% SURGIDENE OINTMENT Gamma Phar-maceuticals Pvt Ltd

    Gamma Pharmaceuticals Pvt Ltd

    SRI LANKA 11-Jul-14 Full

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    14SCHEDULE - II (GROUP A) (Contd.)

    131 POVIDONE IODINE OINTMENT USP 5% VIODIN OINTMENT PharmAce (Pvt) Ltd

    Square Pharmaceuticals Ltd

    BANGLA-DESH

    03-Oct-17 Full

    132 POVIDONE IODINE SOLUTION BP 10% HEMITADINE SOLUTION Himata (Pvt) Ltd Himata (Pvt) Ltd SRI LANKA 17-Sep-18 Provisional

    133 POVIDONE IODINE SOLUTION BP 10% ZYLO-P SOLUTION Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd

    INDIA 19-Mar-15 Full

    134 POVIDONE IODINE TOPICAL SOLUTION USP 10% W/V

    BETADINE SOLUTION Robert Hall & Co Ltd

    G S Pharmabutor (Pvy) Ltd for Win Medical (Pvt) Ltd

    INDIA 12-Feb-14 Full

    135 POVIDONE IODINE U.S.P 5% HEALZ OINTMENT Pharma Associates

    Central drugs and Pharmaceutical

    INDIA 06-May-17 Full

    136 PROPANOL-2 45G+PROPANOL-1 30G+MECETRONIUM ETHYLSULFATE 0.2G/100G SOLUTION

    STERILLUM ANTISEPTIC SOLUTION

    Mamro (Pvt) Ltd Raman & Weil (Pvt) Ltd

    INDIA 12-Aug-16 Full

    137 PYRANTEL PAMOATE 125MG TABLETS **** TABLETS M S J Industries (Ceylon) (Pvt) Ltd

    M S J Industries (Ceylon) (Pvt) Ltd

    SRI LANKA 10-Sep-14 Full

    138 PYRANTEL PAMOATE 125MG TABLETS COMBIFIL-125 TABLETS Sunshine Healthcare lanka Ltd

    Fourrts (India) Laboratories Ltd

    INDIA 18-Apr-16 Full

    139 SALBUTAMOL 1MG+BROMHEXINE HCL. 2MG+GUAIPHENESIN 50MG/5ML

    BENOF SYRUP Inter Pharm (Pvt) Ltd

    Inter Pharm (Pvt) Ltd

    SRI LANKA 23-Aug-14 Full

    140 SALICYLIC ACID 40% W/W DRESSINGS WITH CENTRE RING CONTAING ACID PASTE

    CORN CAPS PLASTER Akbar Pharma-ceuticals (Pvt) Ltd

    Cuxson Gerrard & Co Ltd

    UNITED KINGDOM

    17-May-17 Full

    141 SIMETHICONE 50MG,MAGNESIUM HYDROXIDE 250MG & DRIED ALUMINUM HYDROXIDE GEL 250MG ORAL SUSPENSION

    CORASIL ORAL SUSPENSION

    Harcourts (Pvt) Ltd

    Coral Laboratories Ltd

    INDIA 08-Dec-17 Two Years

    142 SIMETHICONE ORAL SUSPENSION 40MG/06ML DROPPERFUL

    GAS-MED ORAL SUSPENSION

    PharmAce (Pvt) Ltd

    T Man Pharma Ltd.

    THAILAND 03-Dec-17 Two Years

    143 SIMETHICONE ORAL SUSPENSION 40MG/06ML DROPPERFUL

    GAS-MED ORAL SUSPENSION

    PharmAce (Pvt) Ltd

    T Man Pharma Ltd.

    THAILAND 03-Dec-17 Two Years

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    15

    SCHEDULE - II (GROUP A) (Contd.)

    144 SODIUM ALGINATE 500MG+SODIUM BICARBONATE 267MG/10ML

    GAVISCON ORAL SUSPENSION

    Reckitt Benckiser (Lanka) Ltd

    Reckitt Benckser Healthcare UK

    UNITED KINGDOM

    28-Jan-18 Full

    145 SODIUM ALGINATE 500MG+SODIUM BICARBONATE 267MG/10ML

    GAVISCON ORAL SUSPENSION

    Reckitt Benckiser (Lanka) Ltd

    Reckitt Benckser Healthcare UK

    UNITED KINGDOM

    28-Jan-18 Two Years

    146 SODIUM CHLORIDE 1.75MG,POTASIUM CHLORIDE 7.5MG CITRATE DEHYDRATE 14.2G ,DEXTROSE 100MG /500ML LIQUED -BUBBLE GUM FLAVOUR

    PEDITRAL LIQUID

    ORAL SOLUTION

    Morison PLC The Searle Company Ltd

    PAKISTAN 24-Sep-14 Full

    147 SODIUM CHLORIDE 2.6G+TRISODIUM CITRATE 2.9G+POTASSIUM CHLORIDE 1.5G GLUCOSE 13.5G/1000ML

    PEDILIN ORAL ELECTROLY SOLUTION

    PharmAce (Pvt) Ltd

    Alina Combine Pharmaceuticals (Pvt) Ltd

    PAKISTAN 21-May-14 Full

    148 SODIUM CHLORIDE NASAL DROPS 0.9% NORSALINE P NASAL DROPS Morison PLC ATCO Laboratories (Pvt) Ltd

    PAKISTAN 04-Apr-14 Full

    149 SODIUM FLUORIDE AND ACIDULATED PHOSPHATE TOPICAL SOLUTION USP

    FLUORITOP MOUTH WASH George Steuart Health (Pvt) Ltd

    ICPA Health Products Ltd

    INDIA 18-Sep-15 Full

    150 TERBUTALINE SULPHATE BP 1.25MG BROMHEXINE HYDROCHLORIDE BP 4MG & GUAIPHENESIN SYRUP BP 50MG

    LIBITUS PLUS SYRUP

    SYRUP Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd

    INDIA 10-Oct-14 Full

    151 THIAMINE HYDROCHLORIDE 10MG BP TABLETS

    **** TABLETS Inter Pharm (Pvt) Ltd

    Inter Pharm (Pvt) Ltd

    SRI LANKA 28-Jul-17 Full

    152 VIATMIN C 1000MG PLUS,LEMON FLAVONOID COMPLEX 71.45MG POWDER WITH ORANGE FLAVOUR

    NAT-C ESTER POWDER A Baur & Co (Pvt) Ltd

    Mega Lifesciences Public Company (Pvt) Ltd

    THAILAND 28-Jan-16 Full

    153 VIT.B COMPLEX ,THIAMINE 5MG.Ribofi avine 2mg Niacinamide 20mg BP

    STANOVIT B TABLETS Tabrane Healthcare (Pvt) Ltd

    Globe Pharmaceuticals Ltd

    BANGLA-DESH

    26-Apr-14 Full

    154 VITAMIN B COMPLEX SANVITA -B SYRUP

    SYRUP Lifeline Pharma-ceuticals (Pvt) Ltd

    P T Sanbe Farma INDONESIA 19-Aug-14 Full

    155 VITAMIN B COMPLEX **** TABLETS Sunshine Healthcare lanka Ltd

    Axon Drugs (Pvt) Ltd

    INDIA 01-Sep-15 Full

    156 VITAMIN B COMPLEX & IRON DUROL FOR ADULTS

    SYRUP Astron (Pvt) Ltd SRI LANKA 11-Dec-15 Full

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    16SCHEDULE - II (GROUP A) (Contd.)

    157 VITAMIN B COMPLEX AND IRON & ZINC SYRUP

    BIZ SYRUP SYRUP Tabrane Healthcare (Pvt) Ltd

    Globe Pharmaceuticals Ltd

    02-Aug-14 Full

    158 VITAMIN B COMPLEX FORTE+VITAMIN C+ZINC

    BECOZINC CAPSULES Emerchemie NB (Ceylon) Ltd

    Dr Reddy's Laboratories Ltd

    INDIA 19-Nov-17 Two Years

    159 VITAMIN B COMPLEX SYRUP POLYBION SYRUP Emerchemie NB (Ceylon) Ltd

    Merck Limited INDIA 09-Mar-14 Full

    160 VITAMIN B COMPLEX TABLETS (VIT. B1 1MG,B2 1MG & NICOTINAMIDE 10MG)

    * TABLETS Sunshine Healthcare lanka Ltd

    Axon Drugs (Pvt) Ltd

    INDIA 29-Jun-18 Full

    161 VITAMIN B COMPLEX WITH VITAMIN C ENERVON C FILMCAP

    TABLETS George Steuart Health (Pvt) Ltd

    United Laboratories

    PHILIP-PINES

    13-Oct-16 Full

    162 VITAMIN B COMPLEX, VITAMIN B12 AND FOLIC ACID SYRUP

    BECOSULES SYRUP Astron (Pvt) Ltd Astron (Pvt) Ltd SRI LANKA 29-Sep-15 Full

    163 VITAMIN B COMPOUND TABLETS (THIAMIN HCL 1MG+RIBOFLAVIN 1MG NICOTINAMIDE 10MG)

    * TABLETS Morison PLC Morison PLC SRI LANKA 01-Jan-18 Provisional

    164 VITAMIN C SUSTAINED RELEASE TABLETS 500MG

    VITACEE TABLETS Alaris Lanka (Pvt) Ltd

    Contract Manufacuring & Packging Services pty Ltd

    AUSTRA-LIA

    29-Oct-14 Full

    165 VITAMIN MINERAL &TRACE ELEMENTS CAPSULES

    AVITONE CAPSULES Avenier Pharma (Pvt) Ltd

    Triveni Formulations Ltd

    INDIA 14-Mar-15 Full

    166 WATER FOR INJECTION STERILISE SWFI INJECTION Chamee Chemist

    Axa Parenterals Ltd

    INDIA 02-Apr-15 Full

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    17

    SCHEDULE - II (GROUP B) (Contd.)

    COLUMN-I COLUMN-II COLUMN-III COLUMN-IV COLUMN-V COLUMN-VI COLUMN-VII

    COLUMN-VIII

    Generic Name Brand Name Dosage Form Importer Name Manufacturer Country OF Manufactuer

    Issue Date Reg. Type

    1 ABACAVIR TABLETS 300MG ABAMUNE TABLETS Breathe Free Lanka (Pvt) Ltd

    Cipla Ltd INDIA 06-Aug-18 Two Years

    2 ABCIXIMAB INJECTION 10MG IN 5ML

    REOPRO INJECTION Hemas Pharmaceuticals (Pvt) Ltd

    Hospira Inc, USA for Cubist Pharmaceuticals Inc USA

    SWITZERLAND 16-Jul-15 Full

    3 ABCIXIMAB INJECTION 2MG/ML CLOTINAB TM INJECTION Pharma Associates ISU Abxis Co Ltd KOREA 16-Aug-17 Two Years

    4 ABIRATERONE ACETATE TABLETS 250MG

    ZYTIGA TABLETS Pettah Pharmacy (Pvt) Ltd

    Patheon Inc.Canada (pack & Released by Janssen Cilag SPA Italy for Janssen Pharmaceuticals N V

    BELGIUM 21-Feb-16 Full

    5 ABIRATERONE ACETATE TABLETS 250MG

    ABIRAGLOB 250 TABLETS PharmAce (Pvt) Ltd Gobela Pharma (Pvt) Ltd

    INDIA 22-Feb-18 Two Years

    6 ABIRATERONE ACETATE TABLETS 250MG

    N/A TABLETS Yaden International (Pvt) Ltd

    Centurion Laboratories Pvt Ltd

    INDIA 09-Oct-17 Two Years

    7 ABIRATERONE ACETATE TABLETS 250MG

    ABIRON TABLETS Pharma Associates BDR Pharmaceuticals International (Pvt) Ltd

    INDIA 20-Jan-16 Full

    8 ABIRATERONE ACETATE TABLETS 250MG

    AIZERONE TABLETS A V H Distributors (Pvt) Ltd

    Aizant Drugs Research Solution Pvt Ltd

    INDIA 11-Apr-18 Full

    9 ABIRATERONE ACETATE TABLETS USP 250MG

    N/A TABLETS R N Vision Pharma (Pvt) Ltd

    Therdose Pharma (Pvt) Ltd

    INDIA 06-Feb-18 Two Years

    10 ABIRATERONE ACETATE TABLETS USP 250MG

    ABIRATREP TABLETS Emerchemie NB (Ceylon) Ltd

    Dr Reddy's Laboratories Ltd

    INDIA 19-Feb-18 Two Years

  • I fl

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    18SCHEDULE - II (GROUP B) (Contd.)

    11 ACARBOSE TABLETS 100MG GLUCOBAY TABLETS Hemas Pharmaceuticals (Pvt) Ltd

    Bayer Pharma A G GERMANY 18-Mar-18 Full

    12 ACARBOSE TABLETS 100MG ACARB TABLETS Euro Asian Pharma (Pvt) Ltd

    Orchid Healthcare INDIA 26-Feb-14 Full

    13 ACARBOSE TABLETS 50MG GLUCONAY 50 TABLETS Hemas Pharmaceuticals (Pvt) Ltd

    Bayer Pharma A G GERMANY 18-Mar-18 Full

    14 ACARBOSE TABLETS 50MG ABACUS TABLETS Pharma Associates The Madras Pharmaceuticals

    INDIA 20-Jul-14 Full

    15 ACARBOSE TABLETS 50MG GLUCAR TABLETS Hemas Pharmaceuticals (Pvt) Ltd

    Glenmark Pharmaceuticals Ltd

    INDIA 21-Nov-16 Full

    16 ACARBOSE TABLETS 50MG DIABOSE 50 TABLETS Micro Mega Lanka (Pvt) Ltd

    Micro Labs Ltd INDIA 20-Feb-16 Full

    17 ACECLOFENAC CAPSULES 200MG SR

    FECK SR CAPSULES Tabrane Lanka (Pvt) Ltd

    Zim Laboratories Ltd

    INDIA 30-Oct-14 Full

    18 ACECLOFENAC CAPSULES 200MG SR

    ACHAID CAPSULES Emerchemie NB (Ceylon) Ltd

    Inventia Healthcare (Pvt) Ltd

    INDIA 08-May-18 Full

    19 ACECLOFENAC CONTROLLED RELEASE TABLETS 200MG

    ZERODOL-CR TABLETS Hemas Pharmaceuticals (Pvt) Ltd

    IPCA Laboratories INDIA 14-Jun-17 Two Years

    20 ACECLOFENAC ENTERIC COATED TABLETS 100MG

    ATOACE TABLETS Salveo Pharma (Pvt) Ltd

    Pell Tech Health Care (Pvt) Ltd

    INDIA 06-Feb-18 Two Years

    21 ACECLOFENAC ENTERIC COATED TABLETS 10MG

    ATOACE TABLETS Salveo Pharma (Pvt) Ltd

    Pell Tech Health Care (Pvt) Ltd

    INDIA 08-Feb-18 Two Years

    22 ACECLOFENAC FILM COATED TABLETS 100MG

    ACENORM 100 TABLETS Darley Butler & Co Ltd

    Sterling Lab INDIA 09-Apr-14 Full

    23 ACECLOFENAC GEL 1% W/W ACELODON GEL GEL PharmAce (Pvt) Ltd Swiss Garnier Life Scences

    INDIA 09-Jan-17 Full

    24 ACECLOFENAC SUSTAINED RELEASE TABLETS 200MG

    DOLOWIN-SR TABLETS SMM Halcyon (Pvt) Ltd

    Micro Labs Ltd INDIA 17-Jan-18 Two Years

    25 ACECLOFENAC SUSTAINED RELEASE TABLETS 200MG

    RIHA-SR 200 FILM COA TABLETS

    Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd

    INDIA 09-Nov-17 Two Years

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    19

    SCHEDULE - II (GROUP B) (Contd.)

    26 ACECLOFENAC TABLETS BP 100MG

    CECLOFEN TABLETS Emerchemie NB (Ceylon) Ltd

    Renata Limited BANGLADESH 19-Jan-17 Full

    27 ACECLOFENAC TABLETS BP 100MG

    CELOFEN TABLETS CIC Holdings PLC Advanced Chemical Industries

    BANGLADESH 14-Jun-17 Two Years

    28 ACECLOFENAC TABLETS 100MG TUFFOX TABLETS Sunshine Healthcare lanka Ltd

    Eskayef Bangladesh Ltd

    BANGLADESH 07-Jul-18 Two Years

    29 ACECLOFENAC TABLETS 100MG MOBENAC TABLETS Emerchemie NB (Ceylon) Ltd

    Alkem Laboratories Ltd

    INDIA 14-Oct-18 Full

    30 ACECLOFENAC TABLETS 100MG OSICLO TABLETS RS Biogenics (Pvt) ltd

    Oasis Laboratories (Pvt) Ltd

    INDIA 11-Mar-16 Full

    31 ACECLOFENAC TABLETS 100MG MERVAN TABLETS Hemas Pharmaceuticals (Pvt) Ltd

    Aristopharma Ltd BANGLADESH 30-May-14 Full

    32 ACECLOFENAC TABLETS 100MG TERNILLA TABLETS Citihealth Imports (Pvt) Ltd

    Healthcare Pharmaceuticals

    BANGLADESH 02-Oct-18 Two Years

    33 ACECLOFENAC TABLETS 100MG ALFINAC TABLETS Harcourts (Pvt) Ltd Sai Mirra Innopharm (Pvt) Ltd

    INDIA 10-May-18 Provisional

    34 ACECLOFENAC TABLETS 100MG FECK TABLETS Tabrane Pharmaceuticals (Pvt) Ltd

    Zim Laboratories Ltd

    INDIA 01-Feb-15 Full

    35 ACECLOFENAC TABLETS 100MG ZERODOL TABLETS Emar Pharma (Pvt) Ltd

    IPCA Laboratories INDIA 17-Feb-14 Full

    36 ACECLOFENAC TABLETS 100MG ACECLODEAL TABLETS Radiant Health Care (Pvt) Ltd

    Sava Healtheare Ltd

    INDIA 21-Oct-15 Full

    37 ACECLOFENAC TABLETS 100MG ZIX TABLETS Hemas Pharmaceuticals (Pvt) Ltd

    Jenburkt Pharmaceuticals Ltd

    INDIA 03-May-17 Two Years

    38 ACECLOFENAC TABLETS 100MG ACEFLEX 100 TABLETS Darley Butler & Co Ltd

    Navana Pharmaceuticals Ltd

    BANGLADESH 23-Dec-17 Two Years

    39 ACECLOFENAC TABLETS 100MG ACEFEN TABLETS Lifeline Pharmaceuticals (Pvt) Ltd

    Synmedic Laboratories (Pvt) Ltd

    INDIA 14-Oct-16 Full

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    20SCHEDULE - II (GROUP B) (Contd.)

    40 ACECLOFENAC TABLETS 100MG ACLOFEN TABLETS Pharma Associates The Madras Pharmaceuticals

    INDIA 18-Nov-14 Full

    41 ACECLOFENAC TABLETS 100MG ACECLOFAR TABLETS Tropical Pharma (Pvt) Ltd

    S J & G Fazul Ellahie (Pvt) Ltd

    PAKISTAN 14-Aug-15 Full

    42 ACECLOFENAC TABLETS 100MG ACTINAC 100 TABLETS A Baur & Co (Pvt) Ltd

    Ajantha Pharma Ltd

    INDIA 13-Oct-17 Two Years

    43 ACECLOFENAC TABLETS 100MG AROFF TABLETS A Baur & Co (Pvt) Ltd

    Unichem Laboratories

    INDIA 23-Apr-14 Full

    44 ACECLOFENAC TABLETS 100MG MERVAN TABLETS Hemas Pharmaceuticals (Pvt) Ltd

    Aristopharma Ltd BANGLADESH 30-May-14 Full

    45 ACECLOFENAC TABLETS 100MG CDFENAC TABLETS Lifeline Pharmaceuticals (Pvt) Ltd

    G D Laboratories (India) Pvt Ltd

    INDIA 28-Mar-14 Full

    46 ACECLOFENAC TABLETS 100MG APITAC TABLETS Mega Pharma (Pvt) Ltd

    The Acme Laboratories Ltd

    BANGLADESH 06-Sep-17 Two Years

    47 ACECLOFENAC TABLETS 100MG MOVIZ 100 TABLETS George Steuart Health (Pvt) Ltd

    J.B.Chemicals & Pharmaceuticals

    INDIA 01-Mar-18 Two Years

    48 ACECLOFENAC TABLETS 100MG CECLOF TABLETS Ashland Associates Baader Schulz Laboratories

    INDIA 01-Jan-14 Full

    49 ACECLOFENAC TABLETS 100MG ALGIC TABLETS Axia (Pvt) Ltd MSN Laboratories Ltd

    INDIA 09-Dec-14 Full

    50 ACECLOFENAC TABLETS 100MG ACECLOFAR TABLETS PharmAce (Pvt) Ltd Medley Pharmaceuticals Ltd

    INDIA 22-Mar-15 Full

    51 ACECLOFENAC TABLETS 100MG CECLO TABLETS Ceyline Pharmaceuticals (Pvt) Ltd

    Medizan Laboratories (Pvt) Ltd

    PAKISTAN 13-Sep-14 Full

    52 ACECLOFENAC TABLETS 100MG ACECLORIGHT TABLETS Chamee Chemist Alvita Pharma (Pvt) Ltd

    INDIA 06-Jan-16 Full

    53 ACECLOFENAC TABLETS 100MG OSICLO TABLETS Union Lanka Imports (Pvt ) Ltd

    Oasis Laboratories (Pvt) Ltd

    INDIA 11-Mar-16 Full

    54 ACECLOFENAC TABLETS 100MG RUNN 100 FILM COA TABLETS

    ABC Pharma Services Pvt. Ltd

    Alice Pharma Private Ltd.

    INDIA 18-Sep-16 Full

  • I fl

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    21

    SCHEDULE - II (GROUP B) (Contd.)

    55 ACECLOFENAC TABLETS 100MG RESERVIX TABLETS Citihealth Imports (Pvt) Ltd

    Incepta Pharmaceuticals Ltd

    BANGLADESH 15-Mar-17 Two Years

    56 ACECLOFENAC TABLETS 100MG RIHA FILM COA TABLETS

    Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd

    INDIA 25-Mar-15 Full

    57 ACECLOFENAC TABLETS 100MG ACELODON 100 TABLETS PharmAce (Pvt) Ltd Swiss Garnier Life Scences

    INDIA 16-Feb-17 Full

    58 ACECLOFENAC TABLETS 100MG ACLOFRE TABLETS George Steuart Health (Pvt) Ltd

    Fredun Pharmaceuticals Ltd

    INDIA 11-Dec-14 Full

    59 ACECLOFENAC TABLETS 100MG PRESERVIN TABLETS Medinex (Pvt) Ltd The IBN SINA Pharmaceuticals Industry Ltd

    BANGLADESH 24-Nov-14 Full

    60 ACECLOFENAC TABLETS 100MG RILIF 100 TABLETS Gamma Pharmaceuticals Pvt Ltd

    Umedica Laboratories (Pvt) Ltd

    INDIA 07-Nov-14 Full

    61 ACECLOFENAC TABLETS 100MG SUPPAINS TABLETS Hemas Health Care Cadila Healthcare Ltd

    INDIA 26-Sep-14 Full

    62 ACECLOFENAC TABLETS 100MG DOLOWIN TABLETS SMM Halcyon (Pvt) Ltd

    Micro Labs Ltd INDIA 14-Sep-17 Two Years

    63 ACECLOFENAC TABLETS 100MG ZOFEN 100 TABLETS Trendz Healthcare (Pvt) LTD

    Zota Healthcare Ltd

    INDIA 08-Aug-17 Full

    64 ACELAIC ACID CREAM 20% AZIDERM CREAM Mega Pharma (Pvt) Ltd

    Micro Labs Ltd INDIA 11-May-14 Full

    65 ACETAMINOPHEN SUPPOSITORIES USP 125MG

    RECTOL 125 Sunshine Healthcare lanka Ltd

    Bliss GVS Pharma Ltd

    INDIA 05-May-18 Full

    66 ACETAMINOPHEN SUPPOSITORIES USP 125MG

    GALIPAR 125 Tropical Pharma (Pvt) Ltd

    Galen Pharmaceuticals (Pvt) Ltd

    INDIA 18-Mar-17 Full

    67 ACETAZOLAMIDE TABLETS BP 250MG

    N/A TABLETS Yaden International (Pvt) Ltd

    Centurion Laboratories Pvt Ltd

    INDIA 11-Apr-15 Full

    68 ACETAZOLAMIDE TABLETS BP 250MG

    N/A TABLETS Kamazu (Pvt) Ltd Micro Labs Ltd INDIA 22-Aug-15 Full

  • I fl

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    22SCHEDULE - II (GROUP B) (Contd.)

    69 ACETAZOLAMIDE TABLETS BP 250MG

    N/A TABLETS Ravilux Company (Pvt) Ltd

    B D H Industries Ltd

    INDIA 28-Oct-15 Full

    70 ACETAZOLAMIDE TABLETS IP 250MG

    ACETAMIDE 250 TABLETS SMM Halcyon (Pvt) Ltd

    Micro Labs Ltd INDIA 08-Apr-14 Full

    71 ACETAZOLAMIDE TABLETS USP 250MG

    N/A TABLETS The Esses Pharmacy (Pvt) Ltd

    SG Pharma (Pvt) Ltd

    INDIA 10-Apr-16 Full

    72 ACETYLCYSTEINE INJECTION BP 200mg/10ML

    N/A INJECTION Pharma Associates Sreil-Gene Life Science P Ltd

    INDIA 15-Feb-18 Two Years

    73 ACETYLCYSTEINE SOLUTION USP 200MG

    CIROCYST 200 INJECTION Ceyoka (Pvt) Ltd Ciron Drugs & PharmaceuticalS (Pvt) Ltd

    INDIA 29-Jun-16 Full

    74 ACETYLCYSTEINE SOLUTION USP 200mg/ml (2G/10ML)Sterile

    MUCOTYLE SOLUTION The Esses Pharmacy (Pvt) Ltd

    SG Pharma (Pvt) Ltd

    INDIA 06-Feb-14 Full

    75 ACICLOVIR 200MG BP TABLETS N/A TABLETS Akbar Pharmaceuticals (Pvt) Ltd

    Medico Remedies (Pvt) Ltd

    INDIA 12-Dec-17 Two Years

    76 ACICLOVIR 200MG BP TABLETS HERPERAX TABLETS Micro Mega Lanka (Pvt) Ltd

    Micro Labs Ltd INDIA 16-Jul-17 Two Years

    77 ACICLOVIR 400MG TABLETS BP VIRUCID TABLETS Access International (Pvt) Ltd

    Delobris Pharmaceuticals Ltd-AT 01.06.18 Yaden-LO42/17

    CYPRUS 17-Sep-14 Full

    78 ACICLOVIR CREAM BP 5%W/W VIREST CREAM Hadley Bevan Lanka (Pvt) Ltd

    Hovid SDN Bhd MALAYSIA 10-Jun-18 Two Years

    79 ACICLOVIR CREAM BP 5%W/W ACIHERPIN CREAM Citihealth Imports (Pvt) Ltd

    Agio Pharmaceuticals Ltd

    INDIA 03-Apr-15 Full

    80 ACICLOVIR CREAM BP 5%W/W ACIRAX CREAM Lifeline Pharmaceuticals (Pvt) Ltd

    Synmedic Laboratories (Pvt) Ltd

    INDIA 16-Mar-16 Full

    81 ACICLOVIR CREAM BP 5%W/W CYCLOZ CREAM Ceyoka (Pvt) Ltd Focus & Rulz Pharmaceuticals (Pvt) Ltd

    PAKISTAN 23-Aug-17 Two Years

    82 ACICLOVIR CREAM BP 5%W/W DECLOVIR CREAM Indoscan (Pvt) Ltd Hoe Pharmaceuticals SDN BHD

    MALAYSIA 02-Feb-17 Full

  • I fl

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    23

    SCHEDULE - II (GROUP B) (Contd.)

    83 ACICLOVIR EYE OINTMENT BP 3% STERILE

    ACYVIR EYE OINTMENT Hemas Pharmaceuticals (Pvt) Ltd

    Aristopharma Ltd BANGLADESH 02-May-14 Full

    84 ACICLOVIR EYE OINTMENT BP 3% W/w

    EYEVIR EYE OINTMENT George Steuart Health (Pvt) Ltd

    Centaur Pharmaceutical (Pvt) Ltd

    INDIA 16-Jul-16 Full

    85 ACICLOVIR EYE OINTMENT BP 3% W/w

    N/A OINTMENT Yaden International (Pvt) Ltd

    Sunwaya Rohto Pharmaceutical Pvt Ltd

    INDIA 21-Feb-18 Two Years

    86 ACICLOVIR EYE OINTMENT USP 3.0%

    LOVIR OINTMENT Chamee Chemist Indiana Opthalmincs

    INDIA 05-Jun-14 Full

    87 ACICLOVIR INJECTION 250MG ZOVIRAX INJECTION GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd

    Glaxo Smithkiline Manufacturing SPA

    ITALY 21-Mar-15 Full

    88 ACICLOVIR OINTMENT USP 5% HERPERAX OINTMENT Micro Mega Lanka (Pvt) Ltd

    Micro Labs Ltd INDIA 20-Feb-18 Full

    89 ACICLOVIR OPTHALMIC OINTMENT USP 3% w/w

    LOVIR EYE DROPS Delmege Forsyth & Co Ltd

    Remington pharmaceutical Industries (Pvt) Ltd

    PAKISTAN 05-Oct-17 Two Years

    90 ACICLOVIR OPTHALMIC OINTMENT USP 3% w/w

    SANTOVIR EYE OINTMENT Emerchemie NB (Ceylon) Ltd

    Sante (Private) Limited

    PAKISTAN 19-Apr-17 Two Years

    91 ACICLOVIR SODIUM FOR INTRAVENOUS INFUSION 250MG TABLETS BP

    CIROVIR INJECTION Ceyoka (Pvt) Ltd Ciron Drugs & PharmaceuticalS (Pvt) Ltd

    INDIA 23-Jul-15 Full

    92 ACICLOVIR SODIUM FOR INTRAVENOUS INFUSION BP 250MG

    VIR INJECTION Slim Pharmaceuticals (Pvt) Ltd

    Troikaa Pharmaceuticals Ltd

    INDIA 04-Aug-17 Two Years

    93 ACICLOVIR SODIUM FOR INTRAVENOUS INFUSION BP 250MG

    VIR INJECTION Slim Pharmaceuticals (Pvt) Ltd

    Troikaa Pharmaceuticals Ltd

    INDIA 04-Aug-17 Two Years

    94 ACICLOVIR TABLETS BP 200MG ACIHERPIN TABLETS Citihealth Imports (Pvt) Ltd

    Agio Pharmaceuticals Ltd

    INDIA 06-Feb-15 Full

    95 ACICLOVIR TABLETS BP 200MG ACIRAX TABLETS Lifeline Pharmaceuticals (Pvt) Ltd

    Synmedic Laboratories (Pvt) Ltd

    INDIA 28-Mar-14 Full

  • I fl

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    24SCHEDULE - II (GROUP B) (Contd.)

    96 ACICLOVIR TABLETS BP 200MG OVIR TABLETS SMM Halcyon (Pvt) Ltd

    XL Laboratories (Pvt) Ltd

    INDIA 06-Aug-14 Full

    97 ACICLOVIR TABLETS BP 200MG CYCLOVIR TABLETS Sunshine Healthcare lanka Ltd

    Cadila Healthcare Ltd

    INDIA 30-Nov-15 Full

    98 ACICLOVIR TABLETS 200MG ZOVIRAX TABLETS GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd

    Glaxo Wellcom S.A Aranda Spain /Glacosmithkline Australia Pty Ltd

    SPAIN/AUSTRALIA

    25-Nov-17 Full

    99 ACICLOVIR TABLETS BP 200MG CYCLOZ TABLETS Ceyoka (Pvt) Ltd Focus & Rulz Pharmaceuticals (Pvt) Ltd

    PAKISTAN 16-Aug-17 Two Years

    100 ACICLOVIR TABLETS BP 200MG ACYCLOVIR-DENK 200

    TABLETS Akbar Pharmaceuticals (Pvt) Ltd

    Denk Pharma GmbH & Co.

    GERMANY 04-Jul-14 Full

    101 ACICLOVIR TABLETS BP 400MG ACIHERPIN TABLETS Citihealth Imports (Pvt) Ltd

    Agio Pharmaceuticals Ltd

    INDIA 17-Jan-17 Full

    102 ACICLOVIR TABLETS BP 400MG HERPERAX 400 TABLETS Micro Mega Lanka (Pvt) Ltd

    Micro Labs Ltd INDIA 16-Dec-17 Full

    103 ACICLOVIR TABLETS BP 800MG CLOVIREX TABLETS Hemas Pharmaceuticals (Pvt) Ltd

    Brookes Pharma (Pvt) Ltd

    PAKISTAN 14-Sep-17 Two Years

    104 ACiCLOVIR TABLETS BP 800MG N/A TABLETS Chamee Chemist Bajaj Healthcare Ltd

    INDIA 02-May-15 Full

    105 ACICLOVIR TABLETS BP 800MG ACIHERPIN 800 TABLETS Citihealth Imports (Pvt) Ltd

    Agio Pharmaceuticals Ltd

    INDIA 21-Jan-14 Full

    106 ACICLOVIR TABLETS USP 800MG VIRLESS TABLETS Indoscan (Pvt) Ltd Y S P Industries /SDN BHD

    MALAYSIA 11-May-17 Full

    107 ACICLOVIR TABTET USP 200MG SIMPLOVIR TABLETS Citihealth Imports (Pvt) Ltd

    Incepta Pharmaceuticals Ltd

    BANGLADESH 21-Dec-17 Two Years

    108 ACICLOVIR TABTET USP 200MG KAYVIR 200 TABLETS P Jayanetti & Sons Pvt Ltd

    Kausikh Therapeutics (Pvt) Ltd

    INDIA 23-Sep-15 Full

  • I fl

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    A - 09.10.2019

    25

    SCHEDULE - II (GROUP B) (Contd.)

    109 ACICLOVIR TABTET USP 200MG SIMPLOVIR TABLETS Citihealth Imports (Pvt) Ltd

    Incepta Pharmaceuticals Ltd

    BANGLADESH 21-Dec-17 Two Years

    110 ACICLOVIR TABTETS USP 400MG N/A TABLETS Emerchemie NB (Ceylon) Ltd

    Pharmaniaga Manufacturing berhand

    MALAYSIA 15-Feb-18 Full

    111 ACITRETIN CAPSULES 10MG NEOTIGASON CAPSULES Emerchemie NB (Ceylon) Ltd

    Patheon Inc.Canada for F Hoffman La Roche ltd

    CANADA 11-Dec-15 Full

    112 ADALIMUMAB INJECTION 40MG/0.8ML

    CINNORA SOLUTION FOR INJECTION

    Slim Pharmaceuticals (Pvt) Ltd

    CinnaGen Co IRAN 12-Mar-18 Two Years

    113 ADALIMUMAB INJECTION 40MG/0.8ML (SINGLE DOSE)

    EXEMPTIA PRE-FILLED SYRINGES

    Sunshine Healthcare lanka Ltd

    Cadila Healthcare Ltd

    INDIA 16-Nov-18 Provisional

    114 ADAPALENE 0.1%w/w+CLINDAMYCIN PHOSPATE 1% w/w

    CLINALIN GEL PharmAce (Pvt) Ltd Aurochem Pharmaceuticals (India) Ltd

    INDIA 21-Apr-15 Full

    115 ADAPALENE 1MG+CLINDAMYCIN 10MG/G

    DERIVA-C GEL GEL Sunshine Healthcare lanka Ltd

    Glenmark Pharmaceuticals Ltd

    INDIA 04-Jul-18 Provisional

    116 ADAPALENE 1MG+CLINDAMYCIN 10MG/G

    CALENE GEL GEL Bio Tech Pharma (Pvt) Ltd

    Dupen Laboratories (Pvt) Ltd

    INDIA 13-Jan-16 Full

    117 ADAPALENE CREAM 0.1% w/w ADAPCO CREAM TOPICAL CREAM

    Morison PLC ATCO Laboratories (Pvt) Ltd

    PAKISTAN 01-Nov-17 Two Years

    118 ADAPALENE CREAM 0.1% w/w FONA 0.1% CREAM

    CREAM PharmAce (Pvt) Ltd Square Pharmaceuticals Ltd

    BANGLADESH 08-Oct-17 Two Years

    119 ADAPALENE GEL 0.1% ADAFERIN GEL GEL Sunshine Healthcare lanka Ltd

    Laboratories Galderma

    FRANCE 12-Aug-15 Full

    120 ADAPALENE GEL 0.1% ACLENE GEL Hemas Pharmaceuticals (Pvt) Ltd

    Brookes Pharma (Pvt) Ltd

    PAKISTAN 13-Oct-17 Two Years

  • I fl

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    eiÜ m

    ;%h - 2019'10'09

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    A - 09.10.2019

    26SCHEDULE - II (GROUP B) (Contd.)

    121 ADAPALENE GEL 0.1% ADAPCO GEL GEL Morison PLC ATCO Laboratories (Pvt) Ltd

    PAKISTAN 23-Mar-14 Full

    122 ADAPALENE GEL 0.1% ACNEPALE GEL PharmAce (Pvt) Ltd Aurochem Pharmaceuticals (India) Ltd

    INDIA 06-Jun-17 Full

    123 ADAPALENE GEL 0.1% ADAFERIN GEL GEL Sunshine Healthcare lanka Ltd

    Galderma Laboratories

    FRANCE 12-Aug-15 Full

    124 ADAPALENE GEL 0.1% DERIVA AQUEOUS GEL

    AQUE GEL Sunshine Healthcare lanka Ltd

    Glenmark Pharmaceuticals Ltd

    INDIA 24-Jan-18 Two Years

    125 ADAPALENE GEL BP 0.1% ADCEPT GEL Softcare International (Pvt) Ltd

    Concept Pharmaceuticals Ltd

    INDIA 12-Sep-17 Two Years

    126 ADAPALENE GEL MICROSPHERES 0.1%w/w

    DERIVA Ms GEL Sunshine Healthcare lanka Ltd

    Glenmark Pharmaceuticals Ltd

    INDIA 16-Dec-18 Full

    127 ADAPALENE MICROSPHERES 0.1%w/w+CLINDAMYCIN 1.0% W/W GEL

    APLENE-C GEL Harcourts (Pvt) Ltd Parmax Labo. Ltd

    INDIA 03-Apr-14 Full

    128 ADENOSINE INJECTION USP 3MG/ML

    SOLADENO INJECTION The Esses Pharmacy (Pvt) Ltd

    SG Pharma (Pvt) Ltd

    INDIA 16-Oct-14 Full

    129 ADRENALINE (EPINEPHRINE) INJECTION BP 1 IN 1000 (IMG IN 1ML)

    N/A INJECTION Akbar Pharmaceuticals (Pvt) Ltd

    Hameln Pharmaceuticals GmbH Germany Mayne Pharma (Pvt) Ltd

    UNITED KINGDOM

    01-Jun-17 Full

    130 ADRENALINE INJECTION BP 0.1MG (1,1000)

    N/A INJECTION Yaden International (Pvt) Ltd

    Kwality Pharmaceuticals Pvt Ltd

    INDIA 02-Jul-18 Provisional

    131 ADRENALINE INJECTION BP 1,1000 N/A SOLUTION FOR INJECTION

    Niix Holdings (Pvt) Ltd

    Macarthys Laboratories Ltd T/A Martindale Pharmaceuticals

    UNITED KINGDOM

    06-Oct-17 Two Years

    132 ADRENALINE INJECTION BP 1MG IN IML

    N/A INJECTION Ceyoka (Pvt) Ltd Ciron Drugs & PharmaceuticalS (Pvt) Ltd

    INDIA 25-Nov-18 Full

  • I fl

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    ;%h - 2019'10'09

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    A - 09.10.2019

    27

    SCHEDULE - II (GROUP B) (Contd.)

    133 ADRENALINE INJECTION BP 1MG IN IML

    N/A INJECTION Pharma Associates Steril Gene Life Sciences (Pvt) Ltd

    INDIA 26-Apr-18 Two Years

    134 ADRENALINE INJECTION BP 1MG IN IML

    ADEVER INJECTION Leader Pharma Agency Pvt Ltd

    Verve Human Care Laboratories

    INDIA 09-Nov-17 Two Years

    135 ADRENALINE INJECTION BP 1MG IN IML

    ADEVER INJECTION Leader Pharma Agency Pvt Ltd

    Verve Human Care Laboratories

    INDIA 09-Nov-17 Two Years

    136 ADRENALINE INJECTION BP 1MG IN IML

    N/A INJECTION Novachem Lanka (Pvt) Ltd

    Pharmafabrikon Unit

    INDIA 18-Oct-17 Full

    137 ADRENALINE INJECTION BP 1MG IN IML

    N/A INJECTION Yaden International (Pvt) Ltd

    Atlantic Laboratories Corporation Ltd

    THAILAND 26-Nov-14 Full

    138 ADRENALINE INJECTION SYRINGE AUTO INJECTION 0.15MG/0.3ML

    EPIPEN Jr SOLUTION FOR INJECTION

    Emerchemie NB (Ceylon) Ltd

    Meridian Medical Technologies In Colombia

    UNITED STATES

    06-Oct-17 Full

    139 ADRENALINE INJECTION SYRINGE AUTO INJECTION 0.15MG/0.3ML

    EPI PEN SOLUTION FOR INJECTION

    Emerchemie NB (Ceylon) Ltd

    Meridian Medical Technologies In Colombia

    UNITED STATES

    06-Oct-17 Full

    140 ALBENDAZOLE CHEWABLE TABLETS 400MG

    ENDANIL TABLETS SMM Halcyon (Pvt) Ltd

    XL Laboratories (Pvt) Ltd

    INDIA 27-Oct-17 Full

    141 ALBENDAZOLE CHEWABLE TABLETS 400MG

    OLWORM 400 TABLETS Lifeline Pharmaceuticals (Pvt) Ltd

    Synmedic Laboratories (Pvt) Ltd

    INDIA 14-Oct-15 Full

    142 ALBENDAZOLE CHEWABLE TABLETS 400MG

    ALZEN 400 TABLETS Softcare International (Pvt) Ltd

    Ankur Drugs & Pharma (Pvt) Ltd

    INDIA 09-Oct-17 Two Years

    143 ALBENDAZOLE CHEWABLE TABLETS USP 400MG

    ESTAZOLE 400 TABLETS Medinex (Pvt) Ltd The IBN SINA Pharmaceuticals Industry Ltd

    BANGLADESH 21-Dec-17 Two Years

    144 ALBENDAZOLE ORAL SUSPENSION USP 200MG/5ML

    LOKABEN ORAL SUSPENSION

    Slim Pharmaceuticals (Pvt) Ltd

    J Duncan Healthcare (Pvt) Ltd

    INDIA 12-Feb-14 Full

    145 ALBENDAZOLE TABLETS 200MG CHAMPS-D WORMS

    TABLETS Lifeline Pharmaceuticals (Pvt) Ltd

    Upha MALAYSIA 16-Sep-15 Full

    146 ALBENDAZOLE TABLETS 200MG ZENTEL TABLETS GlaxoSmithkiline Pharmaceuticlas (Pvt) Ltd

    Glaxo Smithkiline Pakistan Ltd

    PAKISTAN 05-Apr-17 Two Years

  • I fl

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    ;%h - 2019'10'09

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    A - 09.10.2019

    28SCHEDULE - II (GROUP B) (Contd.)

    147 ALBENDAZOLE TABLETS 400MG ALZEL 400 TABLETS ABC Pharma Services Pvt. Ltd

    Zee Laboratories INDIA 02-Nov-17 Full

    148 ALBENDAZOLE TABLETS 400MG OSIBEN TABLETS RS Biogenics (Pvt) ltd

    Oasis Laboratories (Pvt) Ltd

    INDIA 11-Oct-14 Full

    149 ALBENDAZOLE TABLETS 400MG Al-DS TABLETS Tabrane Healthcare (Pvt) Ltd

    Globe Pharmaceuticals Ltd

    BANGLADESH 12-Apr-14 Full

    150 ALBENDAZOLE TABLETS 400MG OSIBEN TABLETS Union Lanka Imports (Pvt ) Ltd

    Oasis Laboratories (Pvt) Ltd

    INDIA 11-Oct-14 Full

    151 ALBENDAZOLE TABLETS 400MG ENDWORM TABLETS Pharma Associates Bafna Pharmaceuticals Ltd

    INDIA 18-Jul-16 Full

    152 ALBENDAZOLE TABLETS IP 400MG ALBEN CHEWABLE TABLETS

    N/A Astron (Pvt) Ltd SRI LANKA 16-Aug-16 Full

    153 ALBENDAZOLE TABLETS IP 400MG ANTHEL TABLETS Sunshine Healthcare lanka Ltd

    Cadila pharmaceuticals Ltd

    INDIA 15-Jul-14 Full

    154 ALBENDAZOLE TABLETS USP 200MG

    DAZOLE TABLETS George Steuart Health (Pvt) Ltd

    Biolab Co Ltd THAILAND 13-Oct-16 Full

    155 ALBENDAZOLE TABLETS USP 400MG

    ALBEZOLE TABLETS Akbar Pharmaceuticals (Pvt) Ltd

    Medopharm (PVT Ltd

    INDIA 08-Mar-15 Full

    156 ALBENDAZOLE TABLETS USP 400MG

    ALKEN 400 TABLETS Alaris Lanka (Pvt) Ltd

    Gepach International

    INDIA 06-Nov-16 Full

    157 ALBENDAZOLE TABLETS USP 400MG

    LOKABEN TABLETS Slim Pharmaceuticals (Pvt) Ltd

    J Duncan Healthcare (Pvt) Ltd

    INDIA 28-Jan-15 Full

    158 ALBENDAZOLE TABLETS USP 400MG

    ABZ TABLETS Emar Pharma (Pvt) Ltd

    Indoco Remedies India

    INDIA 07-Jun-14 Full

    159 ALBENDAZOLE TABLETS USP 400MG

    UBENDAZOLE TABLETS Gamma Pharmaceuticals Pvt Ltd

    Umedica Laboratories (Pvt) Ltd

    INDIA 09-Aug-15 Full

    160 ALBUMIN BOUND NANOPARTICLE PACLITAXEL INJECTION 100MG

    PACLITAX NAB INJECTION Breathe Free Lanka (Pvt) Ltd

    Cipla Ltd INDIA 27-Nov-17 Two Years

  • I fl

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    A - 09.10.2019

    29

    SCHEDULE - II (GROUP B) (Contd.)

    161 ALBUMIN BOUND NANOPARTICLE PACLITAXEL INJECTION 100MG

    PACLITAX NAB INJECTION Breathe Free Lanka (Pvt) Ltd

    Cipla Ltd INDIA 27-Nov-17 Two Years

    162 ALBUMIN HUMAN SOLUTION FOR INJECTION 20%

    ALBURX 20% SOLUTION INFUSION

    ABC Pharma Services Pvt. Ltd

    CSL Behring GmbH

    SWITZERLAND 19-Oct-18 Provisional

    163 ALCOHOL BASED HAND RUB N/A TOPICAL SOLOTION

    N/A Suraksa Pharma (Pvt) Ltd

    SRI LANKA 15-May-18 Provisional

    164 ALCOHOL BASED HAND RUB N/A TOPICAL SOLOTION

    N/A Suraksa Pharma (Pvt) Ltd

    SRI LANKA 15-May-18 Provisional

    165 ALENDRONATE SODIUM 35MG TABLETS

    OSTEOFOS TABLETS Breathe Free Lanka (Pvt) Ltd

    Cipla Ltd INDIA 07-Sep-14 Full

    166 ALENDRONATE SODIUM TABLETS USP 70MG

    BONATE OW TABLETS PharmAce (Pvt) Ltd Wilshire Laboratories (Pvt) Ltd

    PAKISTAN 09-May-18 Two Years

    167 ALENDRONATE SODIUM TABLETS USP 70MG

    DRATE 70 TABLETS Tropical Pharma (Pvt) Ltd

    S J & G Fazul Ellahie (Pvt) Ltd

    PAKISTAN 31-Jul-15 Full

    168 ALENDRONATE SODIUM TABLETS USP 70MG

    ALDREN 70 TABLETS Hemas Pharmaceuticals (Pvt) Ltd

    Cadila Healthcare Ltd

    INDIA 10-Aug-14 Full

    169 ALENDRONATE SODIUM TABLETS USP 70MG

    BONAFIDE TABLETS Slim Pharmaceuticals (Pvt) Ltd

    Medisure Laboratories Pakistan (Pvt) Ltd

    PAKISTAN 21-Sep-15 Full

    170 ALENDRONATE SODIUM TABLETS USP 70MG

    OSTEOFOS TABLETS Citihealth Imports (Pvt) Ltd

    Cipla Ltd INDIA 18-Jun-14 Full

    171 ALENDRONATE TABLETS 70MG RALENOST 70MG TABLETS Hemas Pharmaceuticals (Pvt) Ltd

    Sun Pharmaceutical industries

    INDIA 03-Apr-14 Full

    172 ALENDRONIC ACID TABLETS 70MG BONGARD 70MG TABLETS CIC Holdings PLC PharmEvo (Pvt) Ltd

    PAKISTAN 10-Sep-18 Two Years

    173 ALENDRONIC ACID TABLETS USP 70MG

    OSTEOMAX 70 TABLETS Tabrane Pharmaceuticals (Pvt) Ltd

    Zim Laboratories Ltd

    INDIA 27-Oct-15 Full

    174 ALFACALCIDOL 0.25MCG ONE ALPHA CAPSULES Hemas Pharmaceuticals (Pvt) Ltd

    Laboratories LEO S.A France for Leo Pharmaceutical ProductsLeo A/S DENMARK

    DENMARK 12-Jun-14 Full

  • I fl

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    A - 09.10.2019

    30SCHEDULE - II (GROUP B) (Contd.)

    175 ALFACALCIDOL 1MCG SOFT GELATIN CAP

    ONE ALPHA SOFT GELETIN CAPSULES

    Hemas Pharmaceuticals (Pvt) Ltd

    LEO Pharma A S DENMARK 18-Nov-17 Full

    176 ALFACALCIDOL CAPSULES 0.25MCG

    CALCICURE SOFT GELETIN CAPSULES

    Slim Pharmaceuticals (Pvt) Ltd

    Olive Healthcare INDIA 09-Dec-15 Full

    177 ALFACALCIDOL CAPSULES 0.25MCG

    ALFACIP 0.25mcg CAPSULES Citihealth Imports (Pvt) Ltd

    Cipla Ltd INDIA 25-Jun-14 Full

    178 ALFACALCIDOL CAPSULES 0.5MCG ONE ALPHA CAPSULES Hemas Pharmaceuticals (Pvt) Ltd

    Laboratories LEO S.A France for Leo Pharmaceutical ProductsLeo A/S DENMARK

    DENMARK 02-Dec-14 Full

    179 ALFACALCIDOL CAPSULES 1.0MCG ALPHADOL CAPSULES Hemas Pharmaceuticals (Pvt) Ltd

    Panacea Biotec (Pvt) Ltd

    INDIA 15-Aug-15 Full

    180 ALFACALCIDOL CAPSULES BP 0.25MCG

    TOPBONE CAPSULES Yaden International (Pvt) Ltd

    Renown Pharmaceuticals Pvt Ltd

    INDIA 12-Feb-18 Two Years

    181 ALFACALCIDOL TABLETS 1MCG XBONE 1MCG TABLETS PharmAce (Pvt) Ltd Wilshire Laboratories (Pvt) Ltd

    PAKISTAN 30-Jan-18 Full

    182 ALGINIC ACID 200MG,MAGNESIUM HYDR.250MG,DRIED ALUMINIUM HYDR.250MG, MAGNISIUM TRIS 250MG,DIMETHICONE 125MG/15ML SUSPENSION

    MEGACID SUSPENSION Sunshine Healthcare lanka Ltd

    Sai Mirra Innopharm (Pvt) Ltd

    INDIA 11-Sep-14 Full

    183 ALLOPURINOL TABLETS BP 100MG ALLONOL TABLETS P Jayanetti & Sons Pvt Ltd

    Kausikh Therapeutics (Pvt) Ltd

    INDIA 05-Mar-14 Full

    184 ALLOPURINOL TABLETS BP 100MG LOGOUT TABLETS Swedish Trading Co Ltd

    Inga Laboraories (Pvt) Ltd

    INDIA 12-Aug-14 Full

    185 ALLOPURINOL TABLETS BP 100MG HILRIC TABLETS MAPS Pharma (Pvt) Ltd

    Hiral Labs Ltd INDIA 02-May-18 Provisional

    186 ALLOPURINOL TABLETS BP 100MG N/A TABLETS Indoscan (Pvt) Ltd Y S P Industries /SDN BHD

    MALAYSIA 12-Nov-14 Full

  • I fl

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    A - 09.10.2019

    31

    SCHEDULE - II (GROUP B) (Contd.)

    187 ALLYLESTRENOL TABLETS 5MG GESTON 5 TABLETS PharmAce (Pvt) Ltd Square Pharmaceuticals Ltd

    BANGLADESH 02-Apr-15 Full

    188 ALPHA LIPOIC ACID,COBALAMIN WITH MULTIVITAMIN CASULES

    NEUROGEN TABLETS Prime Pharma Lanka (Pvt) Ltd

    MMC Healthcare Ltd

    INDIA 14-Oct-16 Full

    189 ALPRAZOLAM TABLETS 0.5MG ZOLARAM 0.5 TABLETS Access International (Pvt) Ltd

    Delobris Pharmaceuticals Ltd-AT 01.06.18 Yaden-LO42/17

    CYPRUS 26-Jul-14 Full

    190 ALPRAZOLAM TABLETS 0.5MG ZOLIUM 0.5 TABLETS Citihealth Imports (Pvt) Ltd

    Incepta Pharmaceuticals Ltd

    BANGLADESH 17-Oct-14 Full

    191 ALPRAZOLAM TABLETS 0.5MG SEDALAM TABLETS Glenford Corporation (Pvt) Ltd

    Aburaihan Pharmaceuticals Company

    IRAN 16-Jul-15 Full

    192 ALPRAZOLAM TABLETS USP 0.25MG

    MANOREST TABLETS Euro Asian Pharma (Pvt) Ltd

    Orchid Healthcare INDIA 14-Jul-18 Full

    193 ALPRAZOLAM TABLETS USP 0.25MG

    B-REST 0.25 TABLETS Browns & Company Plc

    Akums Drugs & Pharmaceuticals Ltd

    INDIA 14-Jun-17 Full

    194 ALPRAZOLAM TABLETS USP 0.25MG

    ALPAZ 0.25 TABLETS Pharma Associates The Madras Pharmaceuticals

    INDIA 04-Jan-15 Full

    195 ALPRAZOLAM TABLETS USP 0.25MG

    ATREST 0.25 TABLETS George Steuart Health (Pvt) Ltd

    Centaur Pharmaceutical (Pvt) Ltd

    INDIA 11-Feb-15 Full

    196 ALPRAZOLAM TABLETS USP 0.25MG

    B-REST 0.25 TABLETS Lotus Pharmaceuticals (Pvt) Ltd

    Akums Drugs & Pharmaceuticals Ltd

    INDIA 14-Jun-17 Full

    197 ALPRAZOLAM TABLETS USP 0.25MG

    ALZOLAM TABLETS Emerchemie NB (Ceylon) Ltd

    Sun Pharmaceutical industries

    INDIA 14-Feb-18 Full

    198 ALPRAZOLAM TABLETS USP 0.5MG TRANQUINALS 0.5

    TABLETS Emerchemie NB (Ceylon) Ltd

    Laboratories Bago S A

    ARGENTINA 11-Oct-18 Provisional

    199 ALPRAZOLAM TABLETS USP 0.5MG B-REST 0.5 TABLETS Browns & Company Plc

    Akums Drugs & Pharmaceuticals Ltd

    INDIA 18-Apr-17 Full

  • I fl

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    ;%h - 2019'10'09

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    A - 09.10.2019

    32SCHEDULE - II (GROUP B) (Contd.)

    200 ALPRAZOLAM TABLETS USP 0.5MG ALZOLAM TABLETS Emerchemie NB (Ceylon) Ltd

    Sun Pharmaceutical industries

    INDIA 14-Feb-18 Full

    201 ALPRAZOLAM TABLETS USP 0.5MG ATREST 0.5 TABLETS George Steuart Health (Pvt) Ltd

    Centaur Pharmaceutical (Pvt) Ltd

    INDIA 20-Jun-16 Full

    202 ALPRAZOLAM TABLETS USP 0.5MG B-REST 0.5 TABLETS Lotus Pharmaceuticals (Pvt) Ltd

    Akums Drugs & Pharmaceuticals Ltd

    INDIA 18-Apr-17 Full

    203 ALPRAZOLAM TABLETS USP 0.5MG MANOREST TABLETS Euro Asian Pharma (Pvt) Ltd

    Orchid Healthcare INDIA 21-Jul-17 Full

    204 ALPROSTADIL INJECTION IP 500MCG

    BIOGIANDIN INJECTION Klintas (Pvt) Ltd United Biotech (Pvt) Ltd

    INDIA 16-Nov-18 Two Years

    205 ALPROSTADIL INJECTION USP 0.5MG/ML

    N/A INJECTION The Esses Pharmacy (Pvt) Ltd

    SG Pharma (Pvt) Ltd

    INDIA 07-Jul-14 Full

    206 ALPROSTADIL INJECTION USP 0.5MG/ML

    ALPOSTIN INJECTION Pharma Associates Samarth Life Sciences (Pvt) Ltd

    INDIA 13-Jun-17 Two Years

    207 ALTEPLASE (RECOMBINANT HUMAN TISSUE TYPE PLASMINOGEN ACTIVATOR INJECTION 20MG

    ACTILYSE INJECTION Hemas Pharmaceuticals (Pvt) Ltd

    Boehringer Ingelheim Pharma gmBH & Co.Kg

    GERMANY 15-Dec-15 Full

    208 ALUMINA , MAGNESIA & SIMETHICONE ORAL SUSPENSION (EACH 5ML CONTAINS,Dried ALUM.HYD BP 400MG,SIMETHICONE SUP 500MG) DOUBLE STRENGTH

    ANTAGIT DS ORAL SUSPENSION

    Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd

    INDIA 28-May-15 Full

    209 ALUMINA , MAGNESIA & SIMETHICONE ORAL SUSPENSION WITH OXETACAINE

    GASTRICAINE ORAL SUSPENSION

    N/A Gamma Pharmaceuticals (Pvt) Ltd

    SRI LANKA 16-Jul-18 Provisional

    210 ALUMINIUM +MAGNESIUM & SIMETHICONE ORAL SUSPENSION

    GASTRIL-MINT ORAL SUSPENSION

    N/A Interpharm (Pvt) Ltd -Sri Lanka

    SRI LANKA 06-Jun-18 Two Years

    211 ALUMINIUM +MAGNESIUM & SIMETHICONE ORAL SUSPENSION

    ANTAGIT DS ORAL SUSPENSION

    Ceyoka (Pvt) Ltd Leben Laboratories (Pvt) Ltd

    INDIA 28-May-15 Full

    212 ALUMINIUM 300MG+MAGNESIUM 250MG & SIMETHICONE 40MG ORAL SUSPENSION USP

    DIOVOL FORTE SUSPENSION Emar Pharma (Pvt) Ltd

    Wallace Pharmaceuticals Ltd

    INDIA 25-May-15 Full

  • I fl

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    A - 09.10.2019

    33

    SCHEDULE - II (GROUP B) (Contd.)

    213 ALUMINIUM HYD 300+MAGNESIUM HYD 150MG & SIMETHICONE BP 125MG+OXETACAINE BP 5MG/5ML

    ANACID FORTE GEL

    ORAL SUSPENSION

    Harcourts (Pvt) Ltd Parmax Labo. Ltd

    INDIA 12-Feb-14 Full

    214 ALUMINIUM HYD.306MG+MAGNESIUM HYD. 110MG+SIMETHICONE 30MG USP ORAL SUSPENSION

    BELEID XTRA ORAL SUSPENSION

    George Steuart Health (Pvt) Ltd

    Biolab Co Ltd THAILAND 06-Jul-18 Two Years

    215 ALUMINIUM HYDROXIDE +MANGESIUM HYDROXIDE +SIMETHICONE USP ORAL SUSPENSION

    PEPTICA GEL ORAL SUSPENSION

    Mansel (Ceylon) (Pvt) Ltd

    Geno Pharmaceuticals Pvt Ltd

    INDIA 14-Feb-17 Full

    216 ALUMINIUM HYDROXIDE BP 120MG + MAGNESIUM TRISILICATE BP 250MG CHEWABLE COMPOUND TABLETS

    N/A TABLETS Pharma Associates Bafna Pharmaceuticals Ltd

    INDIA 01-Mar-15 Full

    217 ALUMINIUM HYDROXIDE DRIED 300MG+MANGESIUM SILICATE HYDR 50MG+SIMETHICONE 25MG (ORANGE)

    DIGENE TABLETS Sunshine Healthcare lanka Ltd

    Abbott India Ltd INDIA 31-Oct-15 Full

    218 ALUMINUM 250MG,MAGNESIA 250MG AND SIMETHICONE BP 50 ORAL SUSPENSION USP

    COOLGEL ORAL SUSPENSION

    Salveo Pharma (Pvt) Ltd

    Mc W Healthcare (P) Ltd

    INDIA 07-Mar-18 Two Years

    219 ALUMINUM HDR. BP 250MG +MAGNESIUM HYD. BP 250MG & SIMETHICONE BP 50MG/5ML

    COOLGEL ORAL SUSPENSION

    Salveo Pharma (Pvt) Ltd

    Mc W Healthcare (P) Ltd

    INDIA 07-Mar-18 Two Years

    220 ALUMINUM HYDROXIDE Dried +MAGNESIUM HYDROXIDE + SIMETHICONE SUSPENSION

    ENICID SYRUP SUSPENSION PharmAce (Pvt) Ltd Enicar Pharmaceuticals Pvt Ltd

    INDIA 04-May-18 Two Years

    221 ALUMINUM HYDROXIDE USP 153MG+MAGNESIUM HYDROXIDE USP 200MG & SIMETHICONE USP 20MG

    BELCID CHEWABLE TABLETS

    George Steuart Health (Pvt) Ltd

    Biolab Co Ltd THAILAND 06-Apr-18 Full

    222 AMANTADINE CAPSULES BP 100MG

    COMANTREL 100 CAPSULES PharmAce (Pvt) Ltd Consern Pharma Pvt Ltd

    INDIA 22-Mar-18 Two Years

    223 AMBROXOL HCL 15MG+TURBUTALINE SULPH 1.5MG +GUAPHENESIN 50MG/5ML SYRUP

    ELTUSS-A SYRUP Siba Healthcare (Pvt) Ltd

    Stallion Laboratories Pvt Ltd

    INDIA 26-Jun-15 Full

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    34SCHEDULE - II (GROUP B) (Contd.)

    224 AMBROXOL HCL BP 15MG+TURBUTALINE SULPH BP 1.25MG +GUAPHENESIN 50MG/5ML SYRUP

    NORVENT SYRUP Pharma Associates Indchemie Health Specialities (Pvt) Ltd

    INDIA 05-Feb-15 Full

    225 AMBROXOL HYDROCHLORIDE 15MG & SALBUTAMOL SULPHATE 1MG SYRUP 5ML

    DAWACOF SYRUP T & J Pharma Imports (Pvt) Ltd

    Lincolin Pharmaceuticals

    INDIA 15-Feb-17 Full

    226 AMBROXOL HYDROCHLORIDE BP SYRUP 30MG/5ML

    AMBROLITE SYRUP CIC Holdings PLC TILL Heathcare Pvt Ltd

    INDIA 20-Sep-18 Two Years

    227 AMBROXOL HYDROCHLORIDE SYRUP 15MG/5ML

    AMBOTEN SYRUP Sunshine Healthcare lanka Ltd

    Eskayef Bangladesh Ltd

    BANGLADESH 09-Jul-14 Full

    228 AMBROXOL HYDROHLORIDE BP SYRUP 30MG/5ML

    MUCOROL SYRUP Alaris Lanka (Pvt) Ltd

    Universal Pharmaceuticals Ltd

    INDIA 05-Jun-17 Two Years

    229 AMBROXOL HYDROHLORIDE SYRUP 15MG/5ML

    AMBOTEN SYRUP Sunshine Healthcare lanka Ltd

    Eskayef Bangaladesh Ltd

    BANGLADESH 09-Jul-14 Full

    230 AMBROXOL HYDROHLORIDE SYRUP 15MG/5ML

    AMBROCARE SYRUP Breathe Free Lanka (Pvt) Ltd

    Cipla Ltd INDIA 31-Jul-15 Full

    231 AMIKACIN SULPHATE INJECTION BP 250MG/2ML

    N/A INJECTION Yaden International (Pvt) Ltd

    Vital Healthcare (Pvt) Ltd

    INDIA 11-Sep-14 Full

    232 AMIKACIN SULPHATE INJECTION BP 500MG/2ML

    N/A INJECTION Yaden International (Pvt) Ltd

    Mercury Laboratories Ltd

    INDIA 28-Dec-18 Two Years

    233 AMIKACIN SULPHATE INJECTION USP 100MG/2ML

    AMPRO 100 INJECTION Access International (Pvt) Ltd

    Protech Biosystems (Pvt) Ltd

    INDIA 26-Jun-15 Full

    234 AMIKACIN SULPHATE INJECTION USP 250MG/2ML

    AMIBAC 250 INJECTION PharmAce (Pvt) Ltd Kavbir Pharmaceutical Pvt Ltd

    INDIA 30-Jul-15 Full

    235 AMIKACIN SULPHATE INJECTION USP 500MG/2ML

    N/A INJECTION P T C Medical (Pvt) Ltd

    Scott Edil Pharmacia Ltd

    INDIA 19-Jun-16 Full

    236 AMIKACIN SULPHATE INJECTION USP 500MG/2ML

    N/A INJECTION Yaden International (Pvt) Ltd

    Vital Healthcare (Pvt) Ltd

    INDIA 19-Jun-17 Full

    237 AMILORIDE HYDROCHLORIDE USP 5MG+HYDROCHLOROTHIAZIDE USP 50MG

    MODURETIC TABLETS Mansel (Ceylon) (Pvt) Ltd

    OBS Pakistan (Pvt) Ltd

    PAKISTAN 05-Apr-17 Full

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    35

    SCHEDULE - II (GROUP B) (Contd.)

    238 AMINO ACID 5% AND SORBITIOL 5% W/V INJECTION

    NIRMIN 5 INJECTION Sunshine Healthcare lanka Ltd

    Aculife Healthcare (Pvt) Ltd

    INDIA 18-Oct-18 Two Years

    239 AMINO ACID ELECTROLYTES 10% W/V

    NIRMIN PLUS INJECTION Sunshine Healthcare lanka Ltd

    Aculife Healthcare (Pvt) Ltd

    INDIA 23-Sep-16 Full

    240 AMINO ACID INJECTION 7% W/V CELEMIN NEPHRO

    INJECTION Akbar Pharmaceuticals (Pvt) Ltd

    Otsuka Pharmaceuticals (Pvt) Ltd

    INDIA 24-Feb-15 Full

    241 AMINO ACID SOLUTION FOR INJ 10%

    AMINOVEN 10% INJECTION Hemas Pharmaceuticals (Pvt) Ltd

    Fresenius Kabi Austria Gmbh Austria Fresenius kabi Ab Sweden

    AUSTRIA 31-Jul-17 Two Years

    242 AMINO ACID SOLUTION FOR INJ 70g/L

    NEPHROSTERIL INJECTION Markss HLC (Pvt) Ltd

    Fresenius Kabi Austria Gmbh Austria Fresenius kabi Ab Sweden

    AUSTRALIA 21-Jan-14 Full

    243 AMINO ACID SOLUTION FOR INTRAVENOUS NUTRITION 65.3G/L

    VAMINOLACT INJECTION Hemas Pharmaceuticals (Pvt) Ltd

    Fresenius Kabi A.B

    AUSTRIA 27-Jul-15 Full

    244 AMINOPHYLLIN 32MG+DIPHENYDRAMINE 8MG+AMMONIUM CHLORID 30MG, MENTHOL 0.98MG/5ML

    AMINOLLIN SYRUP Ceyoka (Pvt) Ltd ISIS Pharmaceuticals & Chemical Works

    PAKISTAN 24-Feb-16 Full

    245 AMINOPHYLLIN PHEUR. 32+DIPHEHYDRAMINE 8MG+AMMONIUM CHLORIDE 30MG/5ML

    EXALYN SYRUP SYRUP Hemas Pharmaceuticals (Pvt) Ltd

    Brookes Pharma (Pvt) Ltd

    PAKISTAN 27-Feb-15 Full

    246 AMINOPHYLLINE INJECTION BP 25MG/ML

    VITAPHYLLINE INJECTION Yaden International (Pvt) Ltd

    Vital Healthcare (Pvt) Ltd

    INDIA 26-Apr-15 Full

    247 AMINOPHYLLINE INJECTION BP 25MG/ML

    N/A INJECTION The Esses Pharmacy (Pvt) Ltd

    SG Pharma (Pvt) Ltd

    INDIA 10-Apr-16 Full

    248 AMIODARONE 150MG/3ML SOLUTION FOR INJECTION

    N/A INJECTION Akbar Pharmaceuticals (Pvt) Ltd

    Hikma pharmaceuticals

    PORTUGAL 20-Jan-14 Full

    249 AMIODARONE CONCENTRAT STERILE INJECTION 50MG/ML

    CORDASOL INJECTION The Esses Pharmacy (Pvt) Ltd

    SG Pharma (Pvt) Ltd

    INDIA 11-Feb-14 Full

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