List of Registered Drugs for January – December 2014

DRUGS REGISTERED IN JANUARY 2014+

DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT STATUS

21-01-14 Caponko 500 Tablets Capecitabine USP 500mg Reliance Life Sciences PVT Ltd India

T. Geddes Grant Distributors Limited

List 4

22-01-14 Montelukast Sandoz 10mg Film Coated Tablets

Montelukast Sodium 10.4mg equivalent to 10mg Montelukast

Sandoz Ilac Sanayi Ve Ticaret A.S., Turkey

Qualcare Limited List 4

22-01-14 Montelukast Sandoz 5mg Chewable Tablets




22-01-14 Montelukast Sandoz 4mg Chewable Tablets




29-01-14 Apo-Letrozole 2.5mg Tablets

letrozole USP Apotex Inc., Canada Cari-Med Limited List 4

31-01-14 Health 2000 Dispersible Aciclovir 400mg Tablets

aciclovir BP 400mg Unicure Remedies Pvt. Ltd., India

Health Brands Limited

List 4

31-01-14 Flexilor 4 Tablets Lornoxicam 4mg tablets Glenmark Pharmaceuticals Ltd., India

T. Geddes Grant Limited

List 4

DRUGS REGISTERED IN JANUARY 2014


31-01-14 Acem 250 Tablets Clarithromycin tablets USP 250mg Emcure Pharmaceuticals Ltd., Pune, Maharashtra, India

Medical Products List 4


31-01-14 Flagasolina Injection for IM/IV use

hydralazine hydrochloride USP 20mg/ml Injection

Flagship Biotech International, Thane, Maharashtra, India

Unimed Limited List 4

31-01-14 C-Tri T 250 Tablets Cefuroxime axetil tablets USP equivalent to cefuroxime

250mg

Emcure Pharmaceuticals Ltd., Pune, Maharashtra, India


31-01-14 C-Tri T 500 Tablets Cefuroxime axetil tablets USP equivalent to cefuroxime 500mg



31-01-14 Acem 500 Tablets Clarithromycin tablets USP 500mg




10-02-14 Eliquis 2.5mg Film-coated Tablets Apixaban 2.5mg Bristol-Myers Squibb Manufactruing Company,

Humacao, Puerto Rico, USA

H.D. Hopwood, List 4

10-02-14 Eliquis 5mg Film-coated Tablets Apixaban 5mg Bristol-Myers Squibb Manufactruing Company,

Humacao, Puerto Rico, USA

H.D. Hopwood List 4

13-02-14 Esoz Inj. 40mg Powder for Solution for IV use only

esomeprazole sodium IH equivalent to esomeprazole 40mg

Glenmark Pharmaceuticals Limited, Kabilpur, Navsari,

Gujarat, India

T. Geddes Grant Limited List 4

13-02-14 Acinject-500 Injection for IM/IV use amikacin sulphate USP 500mg injection

Flagship Biotech International, Thane, Maharashtra, India

Uni-med Limited List 4

13-02-14 Lizolid Injection 200mg/100ml for IV use only

Linezolid 200mg injection, dextrose monohydrate USP

equivalent to dextrose anhydrous 5% w/v water for injection USP q.s

Glenmark Pharmaceuticals Limited, Kheda, Gujarat,

India

T. Geddes Grant Limited,

List 4

13-02-14 Zytop Injection 100mg/5ml for Intravenous use

etoposide USP 100mg/5ml Flagship Biotech International,Solon, Himachal, Pradesh, India

Uni-med Limited, List 4

DRUGS REGISTERED IN FEBRUARY 2014



13-02-14 Z-Cita-1GM Powder for reconstitution for Intravenous Infusion

gemcitabine hydrochloride USP equivalent to gemcitabine 1g

Flagship Biotech International, Solan, Himachal, Pradesh, India

Uni-med Limited

List 4

13-02-14 Z-Cita-200mg Powder for reconstitution for Intravenous Infusion

gemcitabine hydrochloride USP equivalent to gemcitabine 200mg

Flagship Biotech International, Solan, Himachal, Pradesh, India

Uni-med Limited

List 4

10-02-14 Norgesic Tablets Paracetamol/orphenadrine citrate 450mg/35mg

Quimica Y Farmacia, S.A. de C.V., Ramos Arizpe, Coahuila, Mexico

Cari-Med Limited

List 4

13-02-14 Flagtin 50mg/50ml Injection for Intravenous Infusion

cisplatin BP 50mg/50ml injection Flagship Biotech International, Himachal, Pradesh, India

Uni-med Limited

List 4


DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT STATUS12-02-14 Fusifen Cream

2% w/w fusidic acid BP Fourrts (India) Laboratories Pvt. Ltd Inter-Commercial

Distributors LtdList 4

17-02-14 Eylia 40mg/ml Solution for Intravitreal

Injection – Vial, (aflibercept) Regeneron Pharmaceuticals Inc, USA

Lasco Distributors Limited

List 4

18-02-14 Momate 50mcg Nasal Spray – 60 metered doses

each spray delivers mometasone furoate monohydrate equivalent to mometasone furoate 50mcg

Glenmark Pharmaceuticals Ltd., India

T. Geddes Grant Distributors Ltd

List 4

19-02-14 Pemehope 100mg Sterile Lyophilized Powder for constitution for IV Injection

pemetrexed disodium equivalent to pemetrexed 100mg

Glenmark Generics SA, Buenos Aires, Argentina

T. Geddes Grant Distributors Ltd.,

List 4

10-02-14 Oxuba 50mg Sterile Lyophilized Powder for constitution for Intravenous use only

oxaliplatin 50mg ph Eur Glenmark Generics SA, Buenos Aires, Argentina


List 4


19-02-14 Jakavi 5mg Tablets Ruxolitinib phosphate 6.6mg equivalent to ruxolitinib 5mg

Novartis Pharma Stein AG, Stein, Switzerland

Cari-Med Limited List 4







26-02-14 Signifor Solution for Injection 0.3mg/1ml for Subcutaneous use only

Pasireotide diaspartate 0.38mg equivalent to pasireotide 0.3mg












26-02-14 Zupivac H Injection 5mg/5ml

Bupivacaine HCl BP equivalent to anhydrous Bupivacaine HCl 5mg, dextrose (monohydrate) USP 80mg, water for injection USP q.s. (per ml)

Flagship Biotech International, Solon, Himachal, Pradesh, India

Uni-med Limited, List 4

DRUGS REGISTERED IN MARCH 2014

DRUGS

DATE PRODUCT GENERIC DESIGNATION

MANUFACTURER LOCAL AGENT

STATUS

4-03-14 Esem 2.5 Tablets S-Amlodipine besylate equivalent to s-amlodipine 2.5mg

MSN Laboratories Ltd., India

Lasco Distributors Ltd

List 4

4-03-14 Nificard 30 Extended Release Tablets

nifedipine USP 30mg Unique Pharmaceuticals Laboratories, India

Medical Products Limited

List 4

4-03-14 Esem 5 Tablets S-Amlodipine besylate equivalent to s-amlodipine 5mg

MSN Laboratories Ltd., India

Lasco Distributors Ltd

List 4

10-03-14 Emend 125mg/80mg Capsules Each box contains 1 capsule of 125mg aprepitant and 2 capsules of 80mg aprepitant

Alkermes Pharma Ireland Limited

List 4

12-03-14 Flagoda 500mg Tablets Capecitabine 500mg USP

Flagship Biotech International, India

Uni-Med HealthCare Limited

List 4

DATE PRODUCT GENERIC DESIGNATION

MANUFACTURER LOCAL AGENT STATUS

11-03-14 Candesartan Cilexetil/Hydrochlorothiazide Sandoz 8mg/12.5mg tablets

Each tablet contains candesartan cilexetil 8mg hydrochlorothiazide 12.5mg

Lek Pharmaceuticals d.d., Slovenia

Qualcare Limited

List 4


Each tablet contains candesartan cilexetil16mg hydrochlorothiazide 12.5mg


Qualcare Limited

List 4

11-03-14 Candesartan Cilexetil/Hydrochlorothiazide Sandoz 32mg/25mg tablets

Each tablet contains candesartan cilexetil 32mg


Qualcare Limited

List 4

REGISTERED IN MARCH 2014DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS

12-03-14 Ribomustin 100mg powder for

concentrate for solution for infusion-vial for IV injection

Bendamustine hydrochloride 100mg

Oncotec Pharma Producktion GmbH, Germany


12-03-14 Ramlon 5mg/5mg Hard Capsules

Ramipril 5mg; amlodipine besilate 5mg

Egis Pharmaceuticals PLC, H-1165 Budapest, Bokenyfeldi

ut 118-120, Hungary

Medimpex Jamaica Ltd

List 4


Ramipril 10mg; amlodipine besilate 5mg


ut 118-120, Hungary


List 4


Ramipril 10mg; amlodipine besilate

10mg


ut 118-120, Hungary


List 4

13-03-14 Fempro 2.5mg Tablets

Letrozole USP 2.5mg Cipla Ltd., India Lasco Distributors Ltd List 4

13-03-14 Momate 50mcg nasal spray – 120 metered

dose

mometasone furoate monohydrate equivalent to mometasone furoate 0.05% w/w; 50mcg per

spray

Glenmark Pharmaceuticals Ltd., India


List 4


13-03-14 Zaart-25 Tablets losartan potassium, USP, 25mg

M/S Cipla Ltd., Solan, India Lasco Distributors Ltd List 4

13-03-14 Zaart-50 Tablets losartan potassium, USP, 50mg

M/S Cipla Ltd., Solan, India Lasco Distributors Ltd List 4

13-03-14 Scheriproct N Rectal Cream

1gm contains: fluocortolone pivalate, 1mg hidocaine Hcl

20mg

Intendis manufacturing, SpA, Milano, Italy

Lasco Distributors Ltd List 4

14-03-14 Calutide 50 Tablets bicalutamide USP 50mg Cipla Limited, India Lasco Distributors Ltd List 4

14-03-14 Simcard 40mg Tablets Simvastatin USP 40mg Cipla Limited, India Lasco Distributors Ltd List 4

15-03-14 Prednicort Oral Solution Prednisolone sodium phosphate, U.S.P., 5mg/5ml

Incepta Pharmaceuticals Ltd., Dhaka, Bangladesh

Indies Pharma Ja. Ltd List 4

DRUGS REGISTERED IN MARCH 2014


11-03-14 Biosulin M 30/70 100 IU/ml Injection; S.C use only; 10ml vials {Each 1ml suspension contains

100 IU Insulin Human USP (recombinant DNA Origin} as, 70% Human Isulin Isophane suspension & 30% Human Insulin Regular Solution

Popular Pharmaceuticals Ltd., Tongi, Gazipur, Bangladesh

Indies Pharma Ja. Ltd.,

List 4

12-03-14 Health 2000 Meloxicam Tablets B.P. 15mg

Meloxicam , B.P., 15mg M/S Brussels Laboratories Pvt. Ltd., Gujarat, India


List 4

12-03-14 TaDa Tablets Tadalafil 20mg M/S Unicure Remedies Pvt. Ltd., Baroda, India


List 4

25.03.13 Ribomustin 25mg powder for concentrate for solution for infusion-vial for IV injection

Bendamustine hydrochloride 25mg Oncotec Pharma Producktion GmbH, Germany



15-03-14 Cortinase Nasal Spray Each actuation delivers triamcinolone acetonide B.P.,

55 micrograms



15-03-14 Flutinase Nasal Spray Each spray delivers fluticasone propionate, B.P 50mcg



17-03-14 Tolucombi 40mg/12.5mg Tablets

Telmisartan 40mg, hydrochlorothiazide 12.5mg

KRKA d.d. Novo Mesto, Slovenia Servi-Care Distributors Limited

List 4

15-03-14 Azenase Nasal Spray, 120 metered sprays

Each actuation delivers azelastine hydrochloride B.P.,

137mcg



17-03-14 Tolucombi 80mg/25mg Tablets

Telmisartan 80mg, hydrochlorothiazide 25mg

KRKA d.d. Novo Mesto, Slovenia Servi-Care Distributors Limited

List 4

15-03-14 Health 2000 Pentoxifylline Extended Release 400mg

Tablets

pentoxifylline USP 400mg Brussels Laboratories Pvt. Ltd., India Health Brands Limited List 4


18-03-14 Domstop Paediatric Drops

Each 1ml suspension contains: domperidone, B.P

5mg


Indies Pharma Ja. Ltd., List 4

18-03-14 Bioprist-Inj. Vit K Adult; Ampoules; IM/IV/Oral

Only.

1ml ampoule conatins: phytomenadione, B.P., 10mg


Indies Pharma Ja. Ltd., List 4

19-03-14 Intelence 25mg Tablets Etravirine Janssen-Cilag SpA, Italy Cari-Med Limited List 4

27-03-14 Filstat 10 Tablets Atorvastatin calcium trihydrate BP 10.84mg

equivalent to atorvastatin 10mg

Fourrts (India) Laboratories Pvt. Limited

Inter-Commercial Distributors Ltd

List 4





List 4





List 4




List 4

DRUGS REGISTERED IN APRIL 2014DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT STATUS

15-04-14 Lanzul 30mg Gastro-Resistant Capsules

Lansoprazole 30mg KrKA, d.d., Novo Mesto, Slovenia

Servi-Care Distributors Limited

List 4

15-04-14 Ciprinol 500mg Film-Coated Tablets

Ciprofloxacin hydrochloride monohydrate 582mg Ph. Eur.

equivalent to ciprofloxacin 500mg

KrKA, d.d., Novo Mesto, Slovenia


List 4

3-04-14 Carboplatin Injection BP 50mg/5ml for IV infusion

carboplatin BP 10mg/ml Naprod Life Sciences Pvt. Ltd., Boisar, Thane, Maharashtra, India


List 4

3-04-14 Carboplatin Injection BP 450mg/45ml

carboplatin BP 10mg/ml Naprod Life Sciences Pvt. Ltd., Boisar, Thane, Maharashtra, India


List 4


3-04-14 Oxuba 100mg Sterile Lyophylized Powder for Reconstition for IV use

only

Oxaliplatin 100mg Ph Eur Glenmark Generics SA, Buenos Aires, Argentina


List 4

3-04-14 Pemehope 500mg Sterile Lyophylized Powder for

Intravenous use only

pemetrexed disodium equivalent to pemetrexed

500mg

Glenmark Generics SA, Buenos Aires, Argentina


List 4

9-04-14 Imovax Polio Suspension for Injection in

Multidose- Poliomyelitis Vaccine (inactivated)

Sanofi Pasteur S.A., Lyon, France


11-04-14 Duodart 0.5mg/0.4mg Hard Capsules

2Dutaseride 0.5mg & Tamsulosin Hydrochloride

0.4mg

Catalent Germany Schorndorf GmbH,

Steinbeisstr, Schorndorf, Germany

GlaxoSmithKline Caribbean Limited

List 4


15-04-14 Lizolid IV Injection 600mg/300ml

Linezolid IV Injection 600mg/300ml

Glenmark Pharmaceuticals Ltd., Kheda, Gujarat, India


List 4

11-04-14 Stribild Tablets Each tablet contains 150mg elvitegravir, 150mg cobicistat, 200mg emtricitabine, 300mg tenofovir disoproxil fumarate equivalent to 245mg tenofovir

disoproxil

Patheon Inc., Canada H.D. Hopwood & Company Ltd.

List 4

11-04-14 Uro-Vaxom Capsules Standardized lyophilizate 60mg corresponding to 6mg of

lyophilized bacterial lysates of Escherichia Coli

OM Pharma SA, Switzerland Qualcare Limited List 4

14-04-14 Octocaine Ointment 5% - mint flavored

Lidocaine base 5% Novocol Inc, USA Glen Logan List 4


14-04-14 Oni Cream (Betamethasone BP 0.05%

Clotrimazole BP 1% each gram of cream contains betameth {as

dipropionate} 0.5mg and clotrimazole BP 10mg asone BP

Square Pharmaceuticals Ltd., Bangladesh

R.A. Williams Distributors Ltd

List 4

23-04-14 Glivec 100mg Film-coated Tablets

Imatinib 100mg as Mesilate beta crystals

Novartis Pharma Produktions GmbH, Wehr, Baden-

Württenberg, Germany


22-04-14 Stelera 90mg Solution for Injection in

Pre-filled syringe for subcutaneous use Ustekinumab

90mg/ml

Baxter Pharmaceuticals Solutions LLC, Bloomington,

USA & Cilag AG, Schaffhausen, Switzerland


17-04-14 Amisped 4mg Chewable Tablets Montelukast sodium 4.2mg equivalent to montelukast base

4mg

Sanofi Aventis de Colombia S.A.


17-04-14 Amisped 5mg Chewable Tablets Montelukast sodium 5.2mg equivalent to montelukast base

5mg

Sanofi Aventis de Colombia S.A.



17-04-14 Amisped 10mg Film-coated Tablets Montelukast sodium 10.375mg equivalent to montelukast base 10mg

Sanofi Aventis de Colombia S.A. Cari-Med Limited List 4

23-04-14 Ticas 0.05% Cream Each 100gm cream contains fluticasone propionate BP 0.05gm

Square Pharmaceuticals Ltd., Bangladesh R.A. Williams Distributors Ltd List 4

23-04-14 Ticas 0.005% Ointment Each 100gm ointment contains fluticasone propionate BP 0.005gm


24-04-14 Zimax 500 Tablets Each tablet contains azithromycin dihydrate USP 524.04mg equivalent to

azithromycin 500mg


24-04-14 Metaspray Metered Dose Nasal Spray 50mcg/spray

Each spray contains mometasone furoate BP 50mcg


29-04-14 Nufer Syrup Indus Pharmaceuticals, Kancheepuram, India Unimed Health Care Ltd List 4


29-04-14 Foseal – 800 Tablets Sevelamer hydrochloride 800mg Emcure Pharmaceuticals Ltd., Maharashtra State, India

Servi-Care Distributors Limited List 4

29-04-14 Orofer Capsules Iron {III} hydroxide polymaltose complex equivalent to elemental iron,

100mg; folic acid B.P., 550mcg

Emcure Pharmaceuticals Ltd., Jammu, India


29-04-14 Orofer Syrup Each 5ml contains: Iron {III} hydroxide polymaltose complex

equivalent to elemental iron, 50mg

Emcure Pharmaceuticals Ltd., Jammu, India


30-04-14 Pegasys Solution for Injection in Pre-filled Pen; 180 micrograms/0.5ml;

subcutaneous use

Each pre-filled pen contains: 135 micrograms peginterferon alfa-2a {40

KD}

Catalent Belgium, Brussels, Belgium Facey Commodity Company Ltd List 4

30-04-14 Pegasys Solution for Injection in Pre-filled Pen; 135 micrograms/0.5ml;

subcutaneous use

Each pre-filled pen contains: 135 micrograms peginterferon alfa-2a {40

KD})

Catalent Belgium, Brussels, Belgium Facey Commodity Company Ltd List 4

30-04-14 Olpadin Sterile Eye Drops Each 1 ml contains olopatadine hydrochloride, INN, equivalent to

olopatadine 1mg

Aristopharma Ltd., Dhaka, Bangladesh R.A. Williams Distributors Ltd List 4


30-04-14 Low Molecular Weight Heparin Enoxaparin

Sodium Injection 20mg/0.2 Enoxaparin sodium Ph. Eur 20mg/0.2mlml PFs

Gland Pharma Limited, Hyderabad, India

Medical Products Limited List 4

List 4

List 4

List 4

List 4

List 4

List 4


2-05-14 Chlocol Eye Drops Chloramphenicol, B.P., 0.5% w/v M/S Flagship Biotech International, Dist., Thane, India

Uni-Med Health Care Ltd List 4

2-05-14 Pefotrex-500 for Injection; lyophilized; vials; for I.V. Infusion only

Each vial contains pemetrexed 500mg as premetrexed disodium

M/S Flagship Biotech International, Dist., Solan, India

Uni-Med Health Care Ltd., List 4

2-05-14 Panpure IV for Injection; lyophilized; vials; for I.V. Injection only

Each combipack contains: 1 vial, containing S,pantoprazole sodium

equivalent to S (-) pantoprazole 20mg plus 10mg sterile sodium chloride Injection IP

Emcure Pharmaceuticals Ltd., Gujarat State, India


5-05-14 Antiplar Tablets Clopidogrel bisulfate, U.S.P., equivalent to clopidogrel 75mg

Emcure Pharmaceuticals Ltd., Gujarat State, India


8-05-14 Tolura 40mg Tablets Telmisartan KrKa d.d., Novo Mesto, Slovenia Servi-Care Distributors Limited List 4

8-05-14 Tolura 80mg Tablets Telmisartan KrKa d.d., Novo Mesto, Slovenia Servi-Care Distributors Limited List 4

9-05-14 Nolicin 400mg film coated Tablets Norfloxacin 400mg KrKa d.d., Novo Mesto, Slovenia Servi-Care Distributors Limited List 4

DRUGS REGISTERED IN MAY 2014


13-05-14 Vasilip 10mg film coated Tablets Simvastatin KrKa d.d., Novo Mesto, Slovenia


List 4



List 4



List 4

List 4

List 4

List 4

List 4


10-06-14 Meropenem Sandoz 1000mg powder for solution for

injection/infusion

Meropenem trihydrate 1.14155g corresponding to Meropenem per

vial

Sandoz Private Limited, India Qualcare Limited List 4

124-06-14 Levolin Inhaler with dose counter (CFC Free)

Levosalbutamol tartrate equivalent to levosalbutamol 50mcg per dose suspended in tetrafluroethane {HFA-134-a}

propellant

Cipla Limited, Verna, Goa, India


List 4

24-06-14 Oncogem 1000 Powder for reconstitution for IV Infusion

Gemcitabine hydrochloride USP equivalent to Gemcitabine

1000mg

Cipla Limited, Verna, Goa, India


List 4

List 4

List 4

List 4

List 4

DRUGS REGISTERED IN JUNE 2014

DRUGS REGISTERED IN JULY 2014


24-07-14 Tolucombi 80/12.5mg Tablets Telmisartan 80mg, hydrochlorothiazide 12.5mg

KrkA d.d., Novo Mesto, Slovenia Servi-Care Distributors Limited List 4


Each tablet contains candesartan cilexetil 32mg hydrochlorothiazide 12.5mg

Lek Pharmaceuticals d.d., Slovenia Qualcare Limited List 4

28-07-14 Health 2000 Fluconazole150mg Capsules

Fluconazole, U.S.P., 150mg S Kant Healthcare Ltd., Gujarat, India Health Brands Limited List 4

16-07-14 Grafeel Filgrastim Injection 300mcg/1 ml vial SC/IV Infusion

Human Recombinant Granulocyte Colony Stimulating Factor 300mcg/1ml {r-DNA origin})

Dr. Reddy’s Labs Ltd., Biotechnology Division, Ranga Reddy District, Andhra Pradesh, India

Dr. Reddy’s Labs Ltd., List 4

16-07-14 Grafeel Filgrastim Injection 300mcg/1 ml Prefilled Syringe SC/IV Infusion

Human Recombinant Granulocyte Colony Stimulating Factor 300mcg/ per prefilled syringe ml (r-DNA origin}

Dr. Reddy’s Labs Ltd., Biotechnology Division, Ranga Reddy District, Andhra Pradesh, India

Dr. Reddy’s Labs Ltd., List 4

List 4

List 4


2-07-14 Fluorouracil Injection BP 250mg/5ml for IV use

Fluorouracil BP 50mg/ml Naprod Life Sciences PVT Ltd., Andheri (East), Mumbai, India

Inter-Commercial Distributors Limited

List 4

2-07-14 Paclitaxel Injection USP 30mg/5ml for IV Infusion

Paclitaxel USP 6mg/ml Naprod Life Sciences PVT Ltd., Andheri (East), Mumbai, India


List 4

2-07-14 Paclitaxel Injection USP 300mg/50ml for IV Infusion

Paclitaxel USP 6mg/ml Naprod Life Sciences PVT Ltd., Andheri (East), Mumbai, India


List 4

15-07-14 Cymbalta 30mg gastro-resistant capsule, hard

Duloxetine hydrochloride Lilly del Caribe Inc, Puerto Rico Health Brands Limited List 4

15-07-14 Cymbalta 60mg gastro-resistant capsule, hard

Duloxetine hydrochloride Lilly del Caribe Inc, Puerto Rico Health Brands Limited List 4

List 4

List 4

DRUGS REGISTERED IN AUGUST 2014


12-08-14 Clean & Clear Continuous Control Acne Cleanser

Benzoyl Peroxide 10%) Kik Custom Products – Rexdale Plant, Etobicoke, Canada


14-08-14 Simvor Tablets 10mg Simvastatin USP 10mg Ranbaxy Laboratories Ltd., Dewas, India Massy Distribution Ja. Ltd List 4



14-08-14 Enhancin 625mg Tablets Amoxicillin trihydrate Ph Eur equivalent to amoxicillin 500mg, potassium clavulonate Ph Eur equivalent to clavulanic acid 125mg

Ranbaxy Laboratories Ltd., Dewas, (M.P.), India

Massy Distribution Ja. Ltd List 4

14-08-14 Enhancin 1G Tablets Amoxicillin trihydrate Ph Eur equivalent to amoxicillin 875mg, potassium clavulonate Ph Eur equivalent to 125mg

Ranbaxy Laboratories Ltd., Dewas, (M.P.), India


26-08-14 Metpure XL 25 Tablets S {-} metoprolol succinate 23.75mg equivalent to S {-} metoprolol tartrate 25mg

Emcure Pharmaceuticals Ltd., India Servi-Care Distributors Limited List 4


26-08-14 Metpure XL 50 Tablets S {-} metoprolol succinate 47.5mg equivalent to S {-} metoprolol tartrate 50mg

Emcure Pharmaceuticals Ltd., India Servi-Care Distributors Limited List 4

15-08-14 Tramadol-Denk 50mg Effervescent Tablets

Tramadol Hydrochloride 50mg Ph. Eur. Losan Pharma GmbH, Neuenburg, Germany


15-08-14 Momate AZ Nasal Spray Mometasone furoate BP 50mcg, azelastine Hydrochloride BP 140mcg (per spray)

Glenmark Pharmaceuticals Ltd., Tehsil Nalagarh, Solon, Himachal Pradesh, India

T. Geddes Grant Distribution Ltd List 4

15-08-14 Hartmann’s Solution for Injection BP RL

Compound sodium lactate injection BP (sodium lactate USP 0.32g/100ml, sodium chloride BP0.6g/100ml, potassium chloride BP 0.04g/100ml calcium chloride dihydrate BP 0.027g/100ml

Ahlcon Parenterals (India) Ltd., Bhiwadi, Alwar (Rajasthan), India

Medical Products Ltd. List 4

15-08-14 APO-Latanoprost Ophthalmic Solution 50mcg/ml

Latanoprost ophthalmic solution 50mcg/ml Apotex Inc., Richmond Hill, Ontario, Canada


List 4

List 4

DRUGS REGISTERED IN SEPTEMBER 2014


9-09-14 Dermasol 0.05% Cream Each gram cream contains clobetasol propionate BP 0.5mg

Square Pharmaceuticals Ltd., Bangladesh R.A. Williams Distributors Limited List 4

10-09-14 Apo-Mometasone Aqueous Nasal Spray – 50mcg per metered spray

mometasone furoate 50mcg per dose Apotex Inc., Canada Cari-Med Limited List 4

18-09-14 Fluarix Vaccine Influenza Vaccine (Northern Hemisphere 2014-2015 IM/SC Suspension for Injection} See overleaf

GlaxoSmithKline Biologicals, (Branch of SmithKline Beecham Pharma GmbH & Co. KG) Germany

GlaxoSmithKline Caribbean Ltd List 4

11-09-14 Diprobet Cream 0.05% Each 100gm cream contains betamethasone dipropionate BP 0.065GM {equivalent to betamethasone 0.05gm}


12-09-14 Dermasol 0.05% Ointment Each 100gm ointment contains clobetasol propionate BP 0.05mg


12-09-14 Ezex 0.05% Ointment Each gm ointment contains clobetasone butyrate BP 0.5mg


15-09-14 Ezex 0.05% Cream Each gm contains clobetasone butyrate BP 0.5mg



15-09-14 Genvir-500 Tablets Valacyclovir hydrochloride equivalent to Valacyclovir 500mg

Genpharma (International) Pvt. Ltd., Pune, India

Medical Products Limited List 4

15-09-14 Visag Sterile Ophthalmic Solution Azithromycin dihydrate 10mg/1ml Laboratories Poen S.A.C.I.F.I., Buenos Aires, Argentina

T. Geddes Grant Distributors Ltd List 4

15-09-14 Amloval 5/80 Tablets Amlodipine besilate 5mg; valsartan 80mg Popular Pharmaceuticals Ltd., Tongi, Bangladesh


15-09-14 Bactrocin 2% Ointment Each 100gm ointment contains mupirocin USP 2gm


16-09-14 Encifer Injection (Iron Sucrose Injection USP

Each 5ml contains: ferric hydroxide in complex with sucrose equivalent to elemental iron 100mg

Emcure Pharmaceuticals Ltd., Thane, India


23-09-14 Xalaprost Eye Drops Latanoprost 0.05mg/ INN Beximco Pharmaceuticals Ltd., Tongi, Bangladesh


23-09-14 Biosulin Glargine Injection 100 I.U./ ml; 3ml Vials For S.C. use only

Popular Pharmaceuticals Ltd., Tougi, Gazipur, Bangladesh

Indies Pharma Ja., Ltd. List 4


16-09-14 Vifex Syrup Each 5ml contains: salbutamol sulphate, B.P., equivalent to salbutamol, 1mg; bromhexine hydrochloride, B.P., 2mg; guaifenesin, B.P., 50mg

Emcure Pharmaceuticals Ltd., Thane, India


16-09-14 Lexapro 20mg film coated tablets Each tablet contains escitalopram oxalate {INN} 25.54mg corresponding to escitalopram 20mg)

H. Lundbeck A/S, Denmark Massy Distribution (Jamaica) List 4

18-09-14 Akridol 6.25mg Tablets Carvedilol BP 6.25mg Akriti Pharmaceuticals Pvt Ltd., India Recharge Distributors Ltd List 4

18-09-14 Akridol 12.5mg Tablets Carvedilol BP 12.5mg Akriti Pharmaceuticals Pvt Ltd., India Recharge Distributors Ltd List 4

18-09-14 Exelon Patch 15- Transdermal Patch Each 15cm² patch contains 27mg rivastigmine base, in vivo release rate 13.3mg/24h

LTS Lohmann Therapie-Systeme AG, Germany

Cari-Med Ltd. List 4

23-09-14 Apo-Losartan/ HCTZ 100mg/25mg Tablets

Losartan potassium 100mg, hydrochlorothiazide 25mg

Apotex Research Pvt Ltd., India Cari-Med Ltd List 4

23-09-14 Apo-Losartan/ HCTZ 50mg/12.5mg Tablets

Losartan potassium 50mg, hydrochlorothiazide 12.5mg

Apotex Research Pvt Ltd., India Cari-Med Ltd List 4


24-09-14 Moxflag CV 625 Tablets Bharat Parenterals Limited, India Uni-Med Health Care Limited List 4

24-09-14 Moxflag CV 1000 Tablets Bharat Parenterals Limited, India Uni-Med Health Care Limited List 4

25-09-14 Irbesartan Sandoz 300mg Film Coated Tablets

Irbesartan 300mg LEK Pharmaceuticals d.d., Slovenia Qualcare Limited List 4

25-09-14 Irbesartan Sandoz 150mg Film Coated Tablets

Irbesartan 150mg LEK Pharmaceuticals d.d., Slovenia Qualcare Limited List 4

25-09-14 Baxmune 500mg Tablets Mycophenolate mofetil Ph. Eur 500mg Ranbaxy Laboratories Limited, India Massy Distribution (Jamaica) List 4

25-09-14 Seroquel XR Extended Release Tablets 150mg

Quetiapine Fumarate equivalent to 150mg Quetiapine

Astra Zeneca Pharmaceuticals LP, USA Cari-Med Limited List 4

List 4

DRUGS REGISTERED IN OCTOBER 2014


6-10-14 Levepsy 500 Tablets Levetiracetam USP 500mg Cipla Limited, India Lasco Distributors Limited List 4

6-10-14 Levepsy 750 Tablets Levetiracetam USP 750mg Cipla Limited, India Lasco Distributors Limited List 4

7-10-14 Diclofenac Gel 1% Diclofenac diethylamine B.P., 1.16%% w/w equivalent to diclofenac sodium B.P., 1% w/w

S Kant Healthcare Ltd., Gujarat, India Health Brands Limited List 4

8-10-14 Fungiloc Vaginal Pessaries 100mg Each pessary contains clotrimazole BP 100mg

Meridian Enterprises Pvt. Ltd., India Uni-Med Healthcare Limited List 4

8-10-14 Mometasone Furoate 50mcg Nasal SpraySuspension

Each actuation delivers 100mg of suspension containing mometasone furoate monohydrate equivalent to 50mcg mometasone furoate

Lek Pharmaceuticals d.d., Slovenia Qualcare Ltd List 4

9-10-14 Lamivudine/Zidovudine Dispersible Tablets 30mg/60mg

Lamivudine, U.S.P., 30mg; Zidovudine, U.S.P., 60mg

Mylan Laboratories Ltd., Maharashtra State, India

Recharged Distributors Limited List 4

17-10-14 Quexel 850mg film coated tablets Metformin hydrochloride 850mg Sanofi Aventis de Colombia S.A Massy Distribution (Jamaica) Ltd List 4


23-10-14 Ceroxim Suspension 125mg/5ml Each 5ml suspension contains cefuroxime axetil

Ranbaxy Laboratories Ltd., India Massy Distribution (Jamaica) Ltd List 4

27-10-14 CoLosar-Denk 100/12.5mg film coated tablets

Losartan potassium 100mg, hydrochlorothiazide 12.5mg per tablet

Denk Pharma GmbH & Co. KG., Germany

Massy Distribution (Jamaica) Ltd List 4

27-10-14 Anastrozole Denk 1 film coated tablets Each film coated tablet contains anastrozole 1mg

Haupt Pharma Munster GmbH, Germany Massy Distribution (Jamaica) Ltd List 4

27-10-14 Tri-Luma Cream Fluocinolone acetonide 0.01%, hydroquinone 4%, tretinon 0.05%)

G. Production Inc., Canada Cari-Med Limited List 4

29-10-14 Synvisc One Intra-articular Injection 8mg/ml

Contains Hylan GF 20 (repeating disaccharide units of N acetyl glucosamine and sodium

Genzyme Biosurgery, USA (A Division of Genzyme Biosurgery Corporation

Massy Distribution (Jamaica) Ltd List 4

30-10-14 Metsafe 500 ER Tablets Each uncoated table contains metformin hydrochloride USP 500mg as extended release form

MSN Laboratories Private Limited, India Lasco Distributors Ltd List 4

30-10-14 Metsafe 1000 ER Tablets Each uncoated table contains metformin hydrochloride USP 1000mg as extended release form



31-10-14 Lamictal Chewable Dispersible Tablets 2mg

Lamotrigine GlaxoSmithKline LLC, NC, USA GlaxoSmithKline Caribbean Ltd List 4

31-10-14 Levolet 750 Tablets Levofloxacin hemihydrate 768.7mg equivalent to levofloxacin 750mg per film coated tablet

Dr. Reddy’s Laboratories Ltd., India Medical Disposables Limited List 4

31-10-14 Erian Ointment Cinchocaine hydrochloride BP 5mg, hydrocortisone BP 5mg, framycetin sulphate BP 10mg, esculin 10mg per gram of ointment


List 4

List 4

List 4

List 4

DRUGS REGISTERED IN NOVEMBER 2014


11-11-14 Vaxigrip 0.25ml Prefilled Syringe Influenza Vaccine 2014-2015 Sanofi Pasteur S.A., Lyon, France Cari-Med Limited List 4

11-11-14 Vaxigrip 0.5ml Prefilled Syringe Influenza Vaccine 2014-2015 Sanofi Pasteur S.A., Lyon, France Cari-Med Limited List 4

3-11-14 Simponi Solution for Injection 100mg/1ml in Prefilled pen (Smartject-single use for SC Injection)

One (1) ml pre-filled pen contains 100mg golimumab Baxter Pharmaceuticals Solutions LLC, USA


3-11-14 Erian Suppositories Each suppository contains cinchocaine hydro - chloride BP 5mg, hydrocortisone BP 5mg framycetin sulphate BP 10mg, esculin 10mg

Square Pharmaceuticals Ltd., Bangladesh R.A. Williams Distributors Ltd

List 4

3-11-14 LDNIL 40 Tablets Rosuvastatin calcium 41.6mg equivalent to Rosuvastatin 40mg


5-11-14 Cerezol 20 Capsules Temozolomide USP 20mg Flagship Biotech International, India Uni-Med HealthCare Limited List 4

5-11-14 Cerezol 100 Capsules Temozolomide USP 100mg Flagship Biotech International, India Uni-Med HealthCare Limited List 4


4-11-14 Oncogem 200 Powder for reconstitution for IV Infusion

Gemcitabine Hydrochloride USP equivalent to Gemcitabine 200mg & Sodium Chloride Injection IP 0.9% w/v

Cipla Limited, Verna, Goa, India Lasco Distributors Limited List 4

5-11-14 Esomac IV Lyophilized Injection 40mg Esomeprazole sodium for Injection equivalent to Esomeprazole 40mg & Sodium Chloride Injection IP 0.9% w/v

Cipla Limited, Verna, Goa, India Lasco Distributors Limited List 4

14-11-14 Invokana Film-Coated Tablets 300mg Canagliflozin 300mg as canagliflozin hemihydrate306mg

Janssen – Ortho LLC, Gurabo, Puerto Rico, USA / Janssen – Cilag SpA, Italy (packaged & released)


14-11-14 Invokana Film-Coated Tablets 100mg Canagliflozin 100mg as canagliflozin hemihydrate102mg

Janssen – Ortho LLC, Gurabo, Puerto Rico, USA / Janssen – Cilag SpA, Italy (packaged & released)


17-11-14 Cextaz - Ceftazidime for Injection USP 1000mg for IV/IM useVancocyn 1 – Vancomycin Hydrochloride for Injection

Ceftazidime USP 1000mg as ceftazidime pentahydrate a blend of sterile ceftazidime perntahydrate & sterile sodium carbonate

Vida Laboratories Pvt. Ltd., Wilson Garden, Bangalore, India

Medical Disposables & Supplies Limited

List 4

17-11-14 Vancocyn 1 – Vancomycin Hydrochloride for Injection USP 1G for IV use only

Vancomycin Hydrochloride USP equivalent toVancomycin 1G



List 4

17-11-14 Vancocyn – Vancomycin Hydrochloride for Injection USP 500mg for IV use only

Vancomycin Hydrochloride USP equivalent to Vancomycin 500mg



List 4


17-11-14 Rovas 5 film coated tablets Rosuvastatin calcium 5.21mg equivalent to Rosuvastatin 5mg

Intas Pharmaceuticals Ltd., India Wray & Nephew Ltd., (formerly Lascelles Ltd.)

List 4

17-11-14 Rovas 20 film coated tablets Rosuvastatin calcium 20.84mg equivalent to Rosuvastatin 20mg

Intas Pharmaceuticals Ltd., India Wray & Nephew Ltd., (formerly Lascelles Ltd.)

List 4

17-11-14 Gyno V6 Vaginal Tablets 100mg Clotrimazole USP 100mg Akriti Pharmaceuticals Pvt. Ltd., India Recharged Distributors Ltd List 4

18-11-14 Cefotan 1 – Cefotaxime for Injection IV/IM use Cefotaxime sodium USP equivalent to cefotaxime 1G



List 4

18-11-14 Tenox 5mg Tablets Amlodipine besilate 6.94mg equivalent to 5mg amlodipine

Krka d.d., Novo Mesto, Slovenia Servi-Care Distributors Ltd List 4

18-11-14 Tenox 10mg Tablets Amlodipine besilate 13.88mg equivalent to 10mg amlodipine

Krka d.d., Novo Mesto, Slovenia Servi-Care Distributors Ltd List 4

19-11-14 Benzetacil L-A 1200000 IU Powder for Suspension for Injection; IM use

Each 5ml vial contains benzathine penicillin G 1200000 IU

Fresenius Kabi Anti-Infectives S.r.l., Villadose (RO), Italy



19-11-14 Benzetacil L-A 2400000 IU Powder for Suspension for Injection; IM use

Each 5ml vial contains benzathine penicillin G 2400000 IU

Fresenius Kabi Anti-Infectives S.r.l., Villadose (RO), Italy


21-11-14 Glidara 500 Tablets Each film coated tablet contains metformin hydrochloride USP 500mg

Medicamen Biotech Ltd., India Medical Products Limited List 4

21-11-14 Glidara 850 Tablets Each film coated tablet contains metformin hydrochloride USP 850mg

Medicamen Biotech Ltd., India Medical Products Limited List 4

21-11-14 Protride 5 film coated tablets Finasteride 5mg USP Unicure Remedies Pvt. Ltd., India Health Brands Ltd List 4

21-11-14 Grani-Denk 1mg/ml; 1ml concentrate for solution for injection or infusion – single use ampoules for IV use

Each ml concentrate contains granisetron hydrochloride 1.12mg corresponding to granisetron 1mg

Hameln Pharmaceutical GmbH, Germany Massy Distribution (Jamaica) Ltd., List 4

24-11-14 Prasusafe 5 tablets Each film coated tablet contains prasugrel hydrochloride 5.49 mg equivalent to prasugrel 5mg

MSN Laboratories Limited, India Lasco Distributors Ltd List 4

24-11-14 Losar-Denk 25 film coated tablets Each film coated tablet contains losartan potassium 25mg equivalent to losartan 22.9mg

Denk Pharma GmbH & Co. KG, Gollstr. 1, 84529 Tittmoning, Germany

Massy Distribution (Jamaica) Ltd. List 4


25-11-14 Herceptin 150mg powder for concentrate for IV infusion – single dose vial

One vial contains 150mg trastuzumab; reconstituted solution contains 21mg/ml trastuzumab

Roche Diagnostics GmbH, Mannheim, Germany

Facey Commodity Company Ltd List 4

26-11-14 Inalix SR 1.5mg tablets Each film coated sustained release tablet contains indapamide USP 1.5mg

S Kant HealthCare Ltd., India Health Brands Ltd List 4

26-11-14 Aerius Oral Solution 0.5mg/ml Desloratadine Schering Plough S.A. de CV, Mexico Health Brands Ltd List 4

26-11-14 Zoledro-Denk 4mg/5ml concentrate for solution for infusion – vial for IV single use

One vial with 5ml concentrate contains zoledronic acid monohydrate 4.264mg corresponding to zoledronic acid 4mg

Hameln Pharmaceutical GmbH, Germany Massy Distribution (Jamaica) Ltd List 4

27-11-14 Equinixin 25mg/g Granules for Horses Flunixin 250mg as flunixin meglumine BP Veterinary Use Only

Norbrook Laboratories Ltd., Newry, Co, Down, Northern Ireland

Hi-Pro Farm Supplies List 4

27-11-14 Norodine 24 Solution for Injection for IV/IM/SC use

Trimethoprim 40mg/ml suphadiazine 200mg/ml in in 100ml bottle Veterinary Use Only

Norbrook Laboratories Ltd., Newry, Co Down, Northern Ireland


27-11-14 Advil Max Soft Gel Capsules 400mg Ibuprofen 400mg Procaps S.A., Colombia Facey Commodity Company Ltd List 4


14-11-14 Ran CV 500-Ranolazine Extended Release Tablets 500mg

Ranolazine 500mg MSN Laboratories Pvt. Ltd., Medak Dist., Andhra Pradesh, India


19-11-14 Silotrif 8 – Silodosin Capsules 8mg Silodosin 8mg (IHS) MSN Laboratories Pvt. Ltd., Medak Dist., Andhra Pradesh, India


19-11-14 Silotrif 4 – Silodosin Capsules 4mg Silodosin 4mg MSN Laboratories Pvt. Ltd., Medak Dist., Andhra Pradesh, India


27-11-14 Devomycin D Solution for Injection for IM use only

Streptomycin Sulphate 150mg/ml; dihydrostreptomycin Sulphate 150mg/ml in 100ml bottle Veterinary Use Only

Norbrook Laboratories Ltd., Newry, Co Down, North Ireland


28-11-14 Candizar – 4 Tablets Candesartan cilexetil 4mg Ind-Swift Ltd., Global Business Unit, Punjab, India






DRUGS REGISTERED IN DECEMBER 2014


8-12-14 Cefimax – Cefepime for Injection USP 1G for IM/IV use

Cefepime hydrochloride USP equivalent for cefepime 1G



List 4

8-12-14 Espraz – Esomeprazole Sodium for Injection 40mg Powder for reconstitution for IV use only

esomeprazole sodium equivalent to 40mg per vial



List 4

10-12-14 Neupro Transdermal Patch 2mg/24h Rotigotine 4.5mg per 10cm2 patch LTS Lohmann Therapie-Systeme AG, Andernach, Germany


10-12-14 Neupro Transdermal Patch 4mg/24h Rotigotine 9mg per 20cm2 patch LTS Lohmann Therapie-Systeme AG, Andernach, Germany


10-12-14 Neupro Transdermal Patch 6mg/24h Rotigotine 13.5mg per 30cm2 patch LTS Lohmann Therapie-Systeme AG, Andernach, Germany


10-12-14 Neupro Transdermal Patch 8mg/24h Rotigotine 18mg per 40cm2 patch LTS Lohmann Therapie-Systeme AG, Andernach, Germany


18-12-14 Enbrel Myclic 50mg Solution for Injection in Per-filled pen – subcutaneous use

Etanercept Pfizer Ireland Pharmaceuticals, Ireland Facey Commodity Co. Ltd List 4


16-12-14 Aristomol 0.5% Eye Drops Timolol maleate, B.P., 0.5% Aristopharma Ltd., Dhaka, Bangladesh R. A. Williams Distributors Limited List 4

16-12-14 Salinocarb Powder Sodium salimomycin 10%; nicarbazine 10%) Veterinary Use Only - Poultry

Ilender Peru S.A., Lima, Peru Jamaica Broilers Group Ltd List 4

16-12-14 Esmya 5mg Tablets Ulipristal acetate 5mg Gedeon Richter PLC., Budapest, Hungary Medimpex Jamaica Ltd List 4

27-12-14 Combivit Solution for Injection for SC/IM Use

Thiamine HCL 3.5% w/v, riboflavin sodium phosphate 0.05% w/v, pyridoxine HCL 0.7% w/v, nicotinamide 2.3% w/v, ascorbic acid 7% w/v in 100ml bottle Veterinary Use Only

Norbrook Laboratories Ltd., Newry, Co Down, North Ireland


18-12-14 Bridion 200mg/2ml Solution for Injection – vial for IV single bolus; single use

Sugammadex sodium NV Organon, Netherlands Health Brands Ltd List 4

18-12-14 Bridion 500mg/5ml Solution for Injection – vial for IV single bolus; single use

Sugammadex sodium NV Organon, Netherlands Health Brands Ltd List 4

18-12-14 Epnone 25 Film Coated Tablets Eplerenone 25mg tablet MSN Laboartories Ltd., Bollaram, Medak Dist., Andhra Pradesh, India

Lasco Distributors Limited List 4


17-12-14 Nature’s Soul Bioprist’s Herbal Iron Capsules Blood Enriching Formula

Micronised iron 200mg,, emblica officinalis (Indian gooseberry) 75mg, terminalia bellerica (beleric) 5mg,terminalia chebula (yellow myrobalan)75mg, glycyrrhiza glabra (liquorice) 75mg per capsule/per

Bacfo Pharmaceuticals (India) Ltd., Noida, India


serving}18-12-14 Epnone 50 Film Coated Tablets Eplerenone 50mg tablet MSN Laboartories Ltd., Bollaram, Medak

Dist., Andhra Pradesh, IndiaLasco Distributors Limited List 4

18-12-14 Tolvat 15 Tablets Tolvaptan 15mg tablet MSN Laboartories Ltd., Bollaram, Medak Dist., Andhra Pradesh, India


18-12-14 Tolvat 30 Tablets Tolvaptan 30mg tablet MSN Laboartories Ltd., Bollaram, Medak Dist., Andhra Pradesh, India


18-12-14 Kadcyla 100mg Powder for Concentrate for Solution for infusion – vial for IV use

Trastuzumab emtansine DSM Pharmaceuticals Inc., USA Facey Commodity Co. Ltd List 4

18-12-14 Kadcyla 160mg Powder for Concentrate for Solution for infusion – vial for IV use

Trastuzumab emtansine DSM Pharmaceuticals Inc., USA Facey Commodity Co. Ltd List 4

22-12-14 Prezista Oral Suspension 100mg/ml Darunavir 100mg/ml (as darunavir ethanolate 108.4mg/ml

Janssen-Cilag International, Beerse, Belgium


List of Registered Drugs for January – December 2014

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