Suppliers / Kopran Research Laboratories

Kopran Research Laboratories

India Updated 9 July 2026

Kopran Research Laboratories is an API manufacturer based in India. It holds 5 active US drug master files across a filed portfolio of 5 molecules. Its GMP standing is certified by US FDA. 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.

5
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
1
filings across 1 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 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

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
US FDA 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 We do not publish the identity of any buyer.

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Open risk flags

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

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