Suppliers / Megafine Pharma (P)

Megafine Pharma (P)

India 35 employees 2 duplicate records merged Updated 9 July 2026

Megafine Pharma (P) is an API manufacturer based in India. It holds 26 active US drug master files across a filed portfolio of 27 molecules. Its GMP standing is certified by CDSCO (India) and US FDA. Its most recent recorded inspection, by US FDA, closed on 12 May 2023 as VAI. Customs aggregates show $245K of exports covering 3 molecules to 2 destinations in 2025.

26
active US DMFs
0
valid CEPs
4
registered plants 2 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 12 May 2023 VAI US FDA
  • 24 January 2023 VAI US FDA
  • 6 March 2020 OAI US FDA
  • 21 February 2020 OAI US FDA
  • 15 June 2018 OAI US FDA
  • 12 May 2018 OAI US FDA
  • 23 September 2016 OAI US FDA
  • 15 May 2015 OAI US FDA

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

Registered plants

Site FDA FEI
vapi 396 195valsad, India Not on file
Vapi, India Not on file
Nashik, India 3005694111
Vapi, India 3006688078

What they file, and where

Molecule Regulators Docs
Bosentan SFDA (Saudi Arabia), US FDA 3
Mirtazapine SFDA (Saudi Arabia), US FDA 3
Solifenacin Succinate SFDA (Saudi Arabia), US FDA 3
Cinacalcet SFDA (Saudi Arabia), US FDA 2
Donepezil SFDA (Saudi Arabia), US FDA 2
Memantine SFDA (Saudi Arabia), US FDA 2
Rivaroxaban SFDA (Saudi Arabia), US FDA 2
Teriflunomide SFDA (Saudi Arabia), US FDA 2
Venlafaxine US FDA 2
Ambrisentan US FDA 1
Show all 27 molecules on file
Apixaban US FDA 1
Apremilast US FDA 1
Asenapine US FDA 1
Betahistine Dihydrochloride SFDA (Saudi Arabia) 1
Darifenacin US FDA 1
Desvenlafaxine US FDA 1
Edoxaban US FDA 1
Lurasidone US FDA 1
Mirabegron US FDA 1
Paliperidone US FDA 1
Prasugrel US FDA 1
Pyrantel US FDA 1
Quetiapine US FDA 1
Tamsulosin SFDA (Saudi Arabia) 1
Vildagliptin SFDA (Saudi Arabia) 1
Vortioxetine US FDA 1
Ziprasidone US FDA 1

Also appears on these molecule pages

Ambrisentan API Apremilast API Asenapine API Betahistine API Bosentan API Cinacalcet API Darifenacin API Desvenlafaxine API Donepezil API Edoxaban API Memantine API Mirtazapine API
Show 15 more molecule pages
Paliperidone API Prasugrel API Pyrantel API Solifenacin API Teriflunomide API Vortioxetine API Ziprasidone API Quetiapine API Tamsulosin API Venlafaxine API Rivaroxaban API Mirabegron API Vildagliptin API Apixaban API Lurasidone API

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) None 2
US FDA None 1

Scale

Year Revenue Exports Destinations
2025 Not reported $245K 2
2024 Not reported $77K 2
2023 Not reported $1.7M 1
2022 Not reported $563K 3

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

Questions about Megafine Pharma (P)

Does Megafine Pharma (P) hold a US DMF or a CEP?
Megafine Pharma (P) holds 26 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 Megafine Pharma (P) FDA-registered?
2 sites operated by Megafine Pharma (P) carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Megafine Pharma (P)'s last inspection go?
The most recent inspection on record closed on 12 May 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file, of which 6 closed as OAI.
Where does Megafine Pharma (P) manufacture?
4 registered sites are on record, in India (Vapi 396 195valsad, Vapi and Nashik among others). Every site is listed on this page with the register it came from.
What does Megafine Pharma (P) make?
27 molecules are on record against Megafine Pharma (P), including Bosentan, Mirtazapine, Solifenacin Succinate and Cinacalcet. Each links through to that molecule's full manufacturer list.
Which regulators recognise Megafine Pharma (P)'s GMP?
Current GMP certificates are on record from CDSCO (India) and US FDA. 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 VAI, on 12 May 2023.

Comparable suppliers

Apitoria Pharma shares 13 molecules Dr Reddy's Laboratories shares 10 molecules Alembic Pharmaceuticals shares 10 molecules Zydus Lifesciences shares 10 molecules Macleods Pharmaceuticals shares 10 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
EudraGMDP and national regulators
GMP certificates
Customs aggregates
Export values, molecule and destination counts