Suppliers / Morepen Laboratories

Morepen Laboratories

India MOREPENLAB.NS Updated 9 July 2026

Morepen Laboratories is an API manufacturer based in India. It holds 31 active US drug master files and 14 valid CEPs across a filed portfolio of 25 molecules. Its filings concentrate with CDSCO (India) and MINSA (CR). Its most recent recorded inspection, by US FDA, closed on 24 March 2023 as NAI. Customs aggregates show $83.0M of exports covering 1,748 molecules to 87 destinations in 2025.

31
active US DMFs
14
valid CEPs
4
registered plants 3 with an FDA FEI number
5
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
3 of 3 confirmed
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 24 March 2023 NAI US FDA
  • 19 April 2018 NAI US FDA
  • 17 April 2015 VAI US FDA
  • 14 October 2010 VAI US FDA

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

Registered plants

Site FDA FEI
New Delhi, India Not on file
Solan, India 3002807612
Solan, India 3003897648
Baddi, India 3006785414

What they file, and where

Molecule Regulators Docs
Rosuvastatin EDQM, SFDA (Saudi Arabia), US FDA 9
Sitagliptin EDQM, SFDA (Saudi Arabia), US FDA 5
Apixaban SFDA (Saudi Arabia), US FDA 4
Atorvastatin EDQM, SFDA (Saudi Arabia), US FDA 4
Loratadine EDQM, SFDA (Saudi Arabia), US FDA 4
Desloratadine EDQM, SFDA (Saudi Arabia), US FDA 3
Linagliptin SFDA (Saudi Arabia), US FDA 3
Saxagliptin SFDA (Saudi Arabia), US FDA 3
Dapagliflozin US FDA 2
Fexofenadine EDQM, US FDA 2
Show all 25 molecules on file
Montelukast SFDA (Saudi Arabia), US FDA 2
Rivaroxaban EDQM, US FDA 2
Rupatadine EDQM, US FDA 2
Vortioxetine US FDA 2
Bempedoic Acid US FDA 1
Brexpiprazole US FDA 1
Dapagliflozin Propanediol SFDA (Saudi Arabia) 1
Edoxaban US FDA 1
Empagliflozin US FDA 1
Ertugliflozin US FDA 1
Montelukast Sodium EDQM 1
Olmesartan US FDA 1
Olmesartan Medoxomil EDQM 1
Ticagrelor US FDA 1
Vonoprazan US FDA 1

Also appears on these molecule pages

Show 9 more molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 3 None
MINSA (CR) 2 None

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $15.4M 57
2025 $208.0M $83.0M 87
2024 $202.0M $74.9M 76
2023 $171.7M $71.9M 74

Export figures are customs aggregates. We do not publish the identity of any buyer. Revenue shown in US dollars, converted from the reported currency.

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Open risk flags

  • The most recent inspection outcome was NAI, on 24 March 2023.

Sources on this page

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