Suppliers / Metrochem API

Metrochem API

India reconciled across 13 public records · 4 entities Updated 9 July 2026

Metrochem API is an API manufacturer based in India. It holds 23 valid CEPs across a filed portfolio of 27 molecules. Its filings concentrate with CDSCO (India) and MINSA (CR). Customs aggregates show $44.6M of exports covering 1,433 molecules to 61 destinations in 2025.

0
active US DMFs
23
valid CEPs
1
registered plants
19
filings across 2 regulators

Registered plants

Site FDA FEI
Hyderabad, India Not on file

What they file, and where

Molecule Regulators Docs
Esomeprazole EDQM 3
Omeprazole EDQM 3
Bempedoic Acid SFDA (Saudi Arabia) 2
Lansoprazole EDQM, PMDA (Japan) 2
Rabeprazole Sodium Hydrate EDQM 2
Vonoprazan SFDA (Saudi Arabia) 2
Antazoline EDQM 1
Clopidogrel EDQM 1
Copper Sulfate Pentahydrate EDQM 1
Dabigatran Etexilate Mesilate EDQM 1
Show all 27 molecules on file
Dapagliflozin Propanediol SFDA (Saudi Arabia) 1
Dapagliflozin Propylene Glycol Monohydrate EDQM 1
Dimetindene EDQM 1
Empagliflozin SFDA (Saudi Arabia) 1
Lacosamide EDQM 1
Manganese Sulfate Monohydrate EDQM 1
Pantoprazole EDQM 1
Pantoprazole Sodium Sesquihydrate EDQM 1
Prucalopride SFDA (Saudi Arabia) 1
Rabeprazole EDQM 1
Vigabatrin EDQM 1
Zinc Chloride EDQM 1
Zinc Sulfate Heptahydrate EDQM 1
クロピドグレル硫酸塩 PMDA (Japan) 1
ラベプラゾールナトリウム PMDA (Japan) 1
レボセチリジン塩酸塩 PMDA (Japan) 1
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Also appears on these molecule pages

Alogliptin contract manufacturing Bilastine contract manufacturing Canagliflozin contract manufacturing Cetirizine contract manufacturing Clopidogrel contract manufacturing Crisaborole contract manufacturing Dabigatran contract manufacturing Dabigatran Etexilate Mesilate API Dapagliflozin contract manufacturing Dexketoprofen contract manufacturing Dexlansoprazole contract manufacturing Edoxaban contract manufacturing
Show 31 more molecule pages
Efinaconazole contract manufacturing Elagolix contract manufacturing Empagliflozin contract manufacturing Ertugliflozin contract manufacturing Esomeprazole contract manufacturing Etoricoxib contract manufacturing Febuxostat contract manufacturing Fingolimod contract manufacturing Gabapentin contract manufacturing Itraconazole contract manufacturing Ketoprofen contract manufacturing Lansoprazole contract manufacturing Levocetirizine contract manufacturing Levomilnacipran contract manufacturing Loxoprofen contract manufacturing Lurasidone contract manufacturing Milnacipran contract manufacturing Mirabegron contract manufacturing Montelukast contract manufacturing Omeprazole contract manufacturing Pantoprazole contract manufacturing Posaconazole contract manufacturing Prucalopride contract manufacturing Rabeprazole contract manufacturing Ranolazine contract manufacturing Saxagliptin contract manufacturing Silodosin contract manufacturing Siponimod contract manufacturing Tedizolid contract manufacturing Vigabatrin API Lacosamide API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 13 None
MINSA (CR) 6 None

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $6.3M 39
2025 Not reported $44.6M 61
2024 Not reported $40.2M 61
2023 Not reported $55.6M 60

Export figures are customs aggregates. We do not publish the identity of any buyer.

Questions about Metrochem API

Does Metrochem API hold a US DMF or a CEP?
Metrochem API holds 23 valid CEPs. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Where does Metrochem API manufacture?
1 registered site is on record, in India (Hyderabad). Every site is listed on this page with the register it came from.
What does Metrochem API make?
27 molecules are on record against Metrochem API, including Esomeprazole, Omeprazole, Bempedoic Acid and Lansoprazole. Each links through to that molecule's full manufacturer list.
Where does Metrochem API file?
Filings are on record with CDSCO (India) and MINSA (CR), 19 in total.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Comparable suppliers

MSN Laboratories shares 3 molecules Apitoria Pharma shares 3 molecules Dr Reddy's Laboratories shares 2 molecules Alembic Pharmaceuticals shares 2 molecules Torrent Pharmaceuticals shares 2 molecules

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
Customs aggregates
Export values, molecule and destination counts