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: contact@metroapi.com, 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.