Suppliers / Kopran

Kopran

India reconciled across 3 public records · 3 entities Updated 9 July 2026

Kopran is an API manufacturer based in India. It holds 6 active US drug master files across a filed portfolio of 5 molecules. Its filings concentrate with EFDA (ET), ZAMRA (ZM) and TMDA (TZ). Its GMP standing is certified by EDQM, MHRA (UK) and US FDA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 25 April 2025 as NAI. Customs aggregates show $54.5M of exports covering 378 molecules to 45 destinations in 2025.

6
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
130
filings across 10 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 25 April 2025 NAI US FDA
  • 25 January 2019 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
RAIGAD, India Not on file
Mumbai, India Not on file
Raigad, India 3004081315

What they file, and where

Molecule Regulators Docs
Atenolol SFDA (Saudi Arabia), US FDA 2
Metoprolol US FDA 2
Azithromycin US FDA 1
Nitroxoline US FDA 1
Pregabalin SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Atenolol API Azithromycin API Metoprolol API Pregabalin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EFDA (ET) 53 None
ZAMRA (ZM) 24 None
TMDA (TZ) 23 None
DIGEMAPS (DO) 10 None
ARCSA (EC) 9 None
MINSA (CR) 4 None
EDQM None 8
MHRA (UK) None 2
US FDA None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $2.5M 24
2025 Not reported $54.5M 45
2024 Not reported $43.2M 46
2023 Not reported $16.7M 44

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 We do not publish the identity of any buyer.

Questions about Kopran

Does Kopran hold a US DMF or a CEP?
Kopran holds 6 active US drug master files. 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.
Is Kopran FDA-registered?
One site operated by Kopran carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Kopran's last inspection go?
The most recent inspection on record closed on 25 April 2025 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Kopran manufacture?
3 registered sites are on record, in India (Raigad, Mumbai and Raigad). Every site is listed on this page with the register it came from.
What does Kopran make?
5 molecules are on record against Kopran, including Atenolol, Metoprolol, Azithromycin and Nitroxoline. Each links through to that molecule's full manufacturer list.
Which regulators recognise Kopran's GMP?
Current GMP certificates are on record from EDQM, MHRA (UK), US FDA and EMA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

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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Open risk flags

  • The most recent inspection outcome was NAI, on 25 April 2025.

Comparable suppliers

Alembic Pharmaceuticals shares 2 molecules Zydus Lifesciences shares 2 molecules Ipca Laboratories shares 2 molecules HEC Pharm shares 2 molecules Apitoria Pharma shares 1 molecule

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
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts