Suppliers / Mega Fine Pharma

Mega Fine Pharma

India reconciled across 2 public records · 1 entities Updated 9 July 2026

Mega Fine Pharma is an API manufacturer based in India. It holds 5 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by EMA.

0
active US DMFs
5
valid CEPs
3
registered plants
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Mumbai, India Not on file
Nashik, India Not on file
Vapi, India Not on file

What they file, and where

Molecule Regulators Docs
Donepezil EDQM 1
Quetiapine EDQM 1
Rivaroxaban EDQM 1
Solifenacin Succinate EDQM 1
Teriflunomide EDQM 1

Also appears on these molecule pages

Teriflunomide API Quetiapine API Rivaroxaban API Solifenacin API Donepezil API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 2

Questions about Mega Fine Pharma

Does Mega Fine Pharma hold a US DMF or a CEP?
Mega Fine Pharma holds 5 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 Mega Fine Pharma manufacture?
3 registered sites are on record, in India (Mumbai, Nashik and Vapi). Every site is listed on this page with the register it came from.
What does Mega Fine Pharma make?
5 molecules are on record against Mega Fine Pharma, including Donepezil, Quetiapine, Rivaroxaban and Solifenacin Succinate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Mega Fine Pharma's GMP?
Current GMP certificates are on record from 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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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates