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APIs & Pellets
# 302, Bhanu Enclave, Sunder Nagar, Erragadda, Hyderabad - 500 038, India.Tel: 0091-40-2370 0421 / 2381 3969 / 2381 2317 / 2381 6929 (D) Fax: 0091-40-2370 5088
email: [email protected], web: www.metroapi.com
THE COMPANY
Metrochem API PVT Ltd is a major GMP compliant internationally certified, vertically well integrated manufacturer of Active
Pharmaceutical ingredients (API’s), Pellets and Intermediates covering a wide range of Therapeutic segments. It has 6 state
of art production facilities located at Hyderabad and Visakhapatnam (Vizag), India.
The aim of the company is to provide the best in-class products with a focus on solving the customer’s needs. Underlying
this philosophy is an effective blend of technological expertise, experience, infrastructure and capability of working with
diverse clientele in the global Pharmaceutical Industry.
Metrochem is a USFDA (EIR) COFEPRIS, KFDA, IDL certified company. It also has ISO 9001:2008 and WHO GMP
certifications. To further strengthen the value proposition the Company is moving towards EUGMP, TGA and ANVISA. In the
recent past 3 DMF’s have been filed with USFDA.
VOLUME
The 6 manufacturing Facilities are dedicated to 3-core product groups – APIs, Pellets and Intermediates. This gives us the
capability to satisfy the customers with high volume requirements.
Apart from ancillary equipments, our core production equipment includes 200 Stainless Steel Reactors and 50 Glass Lined
Reactors with cumulative reaction volumes of 1250 KL, which produce in excess of 2000 TPA of APIs & Intermediates.
Pelletization plant is equipped with 13 Fluid Bed Coaters & other ancillary equipment to produce in excess of 2400 TPA of
pellets (Enteric coated, Granules and Sustained Release forms) with further expansion on the anvil.
Vizag facility is a green field manufacturing facility spread over 40000 Sqmtrs area having manufacturing blocks, 125
Reactors with 700 KL reaction volume and can produce Kilo to Multi Ton batches. This USFDA approvable facility started
operation in May 2015.
R&D
The manufacturing effort is reinforced with a centralized R&D having 100 Research scientists engaged in development of
APIs and Intermediates.
Additionally a team for Formulation R&D is engaged in development of Pellets, Granules and other Solid Dosage Forms.
CERTIFICATION
USFDA (EIR) Japanese Accreditation
KFDA Approved
WHO GMP Certified ISO 9001:2008 Certified
Granted Patents by Govt. of India Govt. of India Recognized R&D
PEOPLE
Metrochem’s most valuable resource is its people. It is a knowledge-driven company with dedicated professionals at the
helm handling operations, Research & Development, Production, Quality Assurance, Marketing, Material Management
and Finance.
Metrochem is led by a team of highly qualified Technocrats and Managers, supported by a trained and motivated work
force with a commitment to consistently produce high quality products, which meet and often surpass various quality
standards.
QUALITY
Quality is a religion at Metrochem and Improvement is a continuous Endeavour, our quality initiative covers products,
operations and Environment with well designed plants that comply with international requirements.
We have a comprehensive range of analytical instruments like FTIR, Head Space Gas Chromatographs, Double beam
U.V Spectrophotometers, Autotitrators, Digital Polarimeters, Gradient HPLC Systems, ICPMS, Stability Chambers etc.
QA Programme will be further strengthened by an in-house state of art microbiology laboratory which is on the anvil.
The management’s vision is to establish Metrochem as a High Volume-High Quality, Customer-Centric manufacturer by
implementing practices that translate the company’s vision & mission into reality.
API’s Approved by SFDA
Facilities inspected by USFDA, COFEPRIS EUGMP / MHRA / TGA / ANVISA Planned for 2018
Unit - IVUnit - IVAPI's & Intermediates API's & Intermediates
Vizag, A.P., India.Vizag, A.P., India.
Unit - IVAPI's & Intermediates
Vizag, A.P., India.
DMFs available for all Products We can also meet any other specific requirements in the above product range
Contract Manufacturing.Contract Research & Custom Synthesis services available
None of the products will be supplied to countries in which this could be in conflict with existing patents. Further,any products under patent will be offered for R&D purpose only.However the final responsibility lies exclusively with the buyer
API'sAnti Ulceratives
Omeprazole
Omeprazole Sodium
Omeprazole Magnesium
Esomeprazole Magnesium (3H2O)
Esomeprazole Magnesium (2H2O)
Esomeprazole Sodium
Esomeprazole Zinc/ Base/Strontium
Rabeprazole Sodium
Dexrabeprazole Sodium
Lansoprazole
Dexlansoprazole
Pantoprazole Sodium Sesquihydrate
Pantoprazole Sodium Monohydrate
S - Pantoprazole Sodium
Pantoprazole Magnesium
Ilaprazole
Ilaprazole Sodium
Ilaprazole Magnesium
Tenatoprazole Sodium
Anti Fungals
Itraconazole
Posaconazole
Anti Psychotic
Lurasidone Hcl
Levosulpiride
Brexpiprazole
Aripiprazole
Anti Asthmatic
Montelukast Sodium
Anti Epileptic / Anti Convulsant
Vigabatrin
Rufinamide
Gastroprokinetic
Prucalopride Succinate
Itopride HCL
Cinitapride Hydrogen Tartrate
Anti Emetics
Domperidone
Domperidone Maleate
Anti-lnflammatory
Flurbiprofen
Flurbiprofen Axetil / Sodium
Dexflurbiprofen
Ketoprofen Lysine
Dexketoprofen Trometamol
Anti Thalassemia
Deferiprone
Anti Diabetic
Sitagliptin Phosphate
Saxagliptin Hcl
Canagliflozin
Dapagliflozin
Teneligliptin
Ertugliflozin
Anti Osteoarthritis
Etoricoxib
Anti Anginal
Ivabradine
Urinary Incontinence
Mirabegron
lmmuno Modulator
Fingolimod Hcl
Benign Prostatic hypertrophy
Silodosin
Anti Hypertensives
Telmisartan
Azilsartan Medoxomil
Candesartan Cilexetil
Nicardipine Hcl
Nimodipine
Anti Thrombotic / Anti Coagulant
Clopidogrel Bisulphate (form I & II)
Apixaban
Edoxaban
Dabigatran Etexilate Mesylate
Anti Hyperuricemia(Gout)
Febuxostat
Anti Depressant
Duloxetine Hcl
Levomilnacipran Hcl
Antibacterial
Tedizolid Phosphate
Garenoxacin Mesylate
Anti Histamine
Levocetirizine HCL
Bepotastine Besilate
Diuretic
Chlorthalidone
DMFs available for all Products We can also meet any other specific requirements in the above product range
Contract Manufacturing.Contract Research & Custom Synthesis services available
None of the products will be supplied to countries in which this could be in conflict with existing patents. Further,any products under patent will be offered for R&D purpose only.However the final responsibility lies exclusively with the buyer
API's
API's Under Development
Anti Diabetic
Pioglitazone Hcl
Alogliptin Benzoate
Linagliptin
Empagliflozin
Ipragliflozin
Tofogliflozin
Remogliflozin Etabonate
Anti Bacterial
Prulifloxacin
Linezolid
Antihypertensive
Azelnidipine
Macitentan
Metoprolol Succinate
Bisoprolol Fumerate
Antiemetic
Metoclopramide Hcl
Aprepitant
Alizapride
Anti Hyperlipidemic
Atorvastatin Calcium
Rosuvastatin Calcium
Pitavastatin
Anti Depressant
Tandospirone Citrate
Cariprazine hydrochloride
Antithrombotic
Vorapaxar
Sarpogrelate Hcl
Bronchodilator
Ipratropium bromide
Tiotropium bromide
& Monohydrate
Aclidinium Bromide
Benign Prostatic
Hypertrophy
Naftopidil di Hcl
Antiglaucoma Agent
Timolol Hemihydrate
& Hydrogen
Maleate Salt
Anti Fungal
Isavuconazole
Tardive Dyskinesia
Valbenazine
Anti Parkinson’s Agents
Safinamide Mesylate
Pimavanserin Tartrate
Anti Hyperparathyroidism
Etelcalcetide
Calcifediol
Atopic Dermatitis
Crisaborole
To treat of Carcinoid
Syndrome Diarrhoea
Telotristat Etiprate
Antibacterial
Rifaximin
To treat erectile
dysfunction
Vardenafil Dihydrochloride
Antihyperparathyroid
Cinacalcet Hcl
Urinary Incontinence
Solifenacin succinate
Fesoterodine fumerate
Tolterodine tartrate
Anti Histamine
Masilukast
Bilastine
Loratadine
Desloratadine
Carbinoxamine
Anti Ulcerative
Lafutidine
Vonoprazan
To treat attention
Deficit Hyperactivity
Disorder (ADHD)
Atomoxetine Hcl
To Treat Alzheimer's
Disease
Galantamine HBr & Hcl
Donepezil Hcl
Osteoporosis
Ergocalciferol
Anti Gout
Colchiceine
Topiroxostat
Antianginal
Ranolazine
Anticonvulsant / Anti epileptic
Eslicarbazepin Acetate
Perampanel
Debriding Agent / Vulnerary
Allantion
Anti Rheumatic
Tofacitinib citrate
Baricitinib
Methotrexate
Leflunomide
Anti Psoriasis
Ruxolitinib Phosphate
Apremilast
COPD
Roflumilast
Hypnotic Sedative
Suvorexant
Anti Viral
Dolutegravir
Pellets Enteric Coated Pellets,
Granules & Sustained Release Forms
Anti Ulceratives
Omeprazole Pellets - 7.5%, 8.5%, 10%, 12.5%, 15%, 20%, 25%, etc.,
Esomeprazole Magnesium Pellets - 8.5%, 10%, 15%, 22.5%, 23.5%, 26.67% etc.,
Esomeprazole Dihydrate Pellets - 8.5%, 10%, 15%, 22.5% etc.,
Lansoprazole Pellets - 6%, 7.5%, 8.5%, 10%, 10.5%, 11%, 11.2%, 11.5%, 12%, 14% etc.,
Rabeprazole Pellets - 7.5%, 8.5%, 13.33%, 15%, 17%, 20%, 22.5% etc.,
S-Pantoprazole Pellets - 20% etc.,
Dexrabeprazole Pellets - 8.5%, 10%, 15% etc.,
Dexlansoprazole Pellets - 8.5%, 10% etc.,
Anti Fungals
Itraconazole Pellets - 20%, 22%
Anti Emetics
Domperidone Pellets 10%, 20%, 30%, 40%
SR - Sustained release Pellets
Domperidone (SR) Pelles - 10%, 20%, 30%, 40%
Gastroprokinetic
Itopride HCl (SR) Pellets - 60%
Anti Inflammatories
Diclofenac Sodium Pellets (SR) - 40%, 50%
Diclofenac Potassium Pellets (SR) - 40%, 50%
Ketoprofen Pellets (SR) - 70%
Anti Spasmodics
Mebeverine pellets (SR) - 20%, 40%
Benign Prostatic hypertrophY
Tamsulosin Pellets (SR) - 0.12%, 0.2%, 0.4%
Anti Psychotic
Levosulpiride Pellets - 50%
DMFs available for all Products We can also meet any other specific requirements in the above product range
Contract Manufacturing.Contract Research & Custom Synthesis services available
None of the products will be supplied to countries in which this could be in conflict with existing patents. Further,any products under patent will be offered for R&D purpose only.However the final responsibility lies exclusively with the buyer
DMFs available for all Products We can also meet any other specific requirements in the above product range
Contract Manufacturing.Contract Research & Custom Synthesis services available
None of the products will be supplied to countries in which this could be in conflict with existing patents. Further,any products under patent will be offered for R&D purpose only.However the final responsibility lies exclusively with the buyer
Pellets Enteric Coated Pellets,
Granules & Sustained Release Forms
Anti Obesity
Orlistat Pellets - 50%
Blended / Combination Pellets
Omeprazole (EC) & Domperidone (SR)
Pantoprazole Sodium (EC) & Domperidone IR & SR
Rabeprazole Sodium (EC) & Domperidone (SR)
Esomeprazole Magnesium (EC) & Domperidone (SR)
Other Pellets
Aspirin Pellets 70%
Levomilnacipran Hcl Pellets
Flurbiprofen Pellets 57 .1 4%
Diltiazem HCI Pellets 50%
Tolterodine Tartrate Pellets 2.0%
Fluoxetine HCI Pellets 70%
Theophylline Pellets 70%
Metoprolol Succinate Pellets 50%, 60%
Tramadol HCI Pellets 10%
Indomethacin Pellets 20%
Mesalamine Pellets
Dutasteride Pellets 0.5%
Iron poly maltose pellets
Galantamine Pellets
Tacrolimus Pellets
Pregabalin Pellets 50%
Aprepitant pellets
Ferrous Sulphate & Folic acid pellets
Atorvastatin Pellets 7.5%, 10.0%
Tamsulosin & Dutasteride Pellets
Oxeladin Pellets
Duloxetine Pellets
Donepezil pellets
Telmisartan Pellets
Nicardipine Pellets
Fenofibrate Pellets
Clopidogrel Pellets
Ciprofloxacin Pellets 20%
Dabigatran Pellets
Tenatoprazole Pellets
Cinitapride Pellets
Terbinafine Hcl Pellets
Combination&speciality Pellets
Taste Masking Pellets
Mups
Micro granules - for direct compression
Any Other Pellets can be developed on request
Muscle Relaxants
Tizanidine HCI Pellets (SR) - 3.5%
Anti Asthmatic
Budesonide Pellets (SR) - 1.0%
Anti Depressants
Venlafaxine HCI Pellets (SR) - 25%, 33%, 35%
PELLETS
GLOBAL PRESENCE
Unit - II Unit - II Pellets Pellets
Hyderabad, India.Hyderabad, India.
Unit - II Pellets
Hyderabad, India.
Unit - IUnit - IAPI's & Intermediates API's & Intermediates
Hyderabad, India.Hyderabad, India.
Unit - IAPI's & Intermediates
Hyderabad, India.