Suppliers / Fishfa Biogenics

Fishfa Biogenics

India Updated 9 July 2026

Fishfa Biogenics is an API manufacturer based in India. It holds 3 active US drug master files and one valid CEP across a filed portfolio of 3 molecules. Its GMP standing is certified by CDSCO (India) and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 January 2026 as VAI.

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

Inspection history

  • 30 January 2026 VAI US FDA

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

Registered plants

Site FDA FEI
Rajkot, India 3017150186
Rajkot, India Not on file
rajkot 360 003, India Not on file

What they file, and where

Molecule Regulators Docs
Tacrolimus EDQM, US FDA 2
Cyclosporine US FDA 1
Mupirocin US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

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

Questions about Fishfa Biogenics

Does Fishfa Biogenics hold a US DMF or a CEP?
Fishfa Biogenics holds 3 active US drug master files and 1 valid CEP. 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 Fishfa Biogenics FDA-registered?
One site operated by Fishfa Biogenics 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 Fishfa Biogenics's last inspection go?
The most recent inspection on record closed on 30 January 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Fishfa Biogenics manufacture?
3 registered sites are on record, in India (Rajkot and Rajkot 360 003 among others). Every site is listed on this page with the register it came from.
What does Fishfa Biogenics make?
3 molecules are on record against Fishfa Biogenics, including Tacrolimus, Cyclosporine and Mupirocin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fishfa Biogenics'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 30 January 2026.

Sources on this page

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