Suppliers / Enzene Biosciences

Enzene Biosciences

India Updated 9 July 2026

Enzene Biosciences is a finished-dose manufacturer based in India. It appears in 17 regulatory filings across 2 regulators, without an active US DMF or CEP on file. Its filings concentrate with CDSCO (India) and JFDA (JO). Its GMP standing is certified by EMA. Customs aggregates show $705K of exports covering 170 molecules to 13 destinations in 2025.

0
active US DMFs
0
valid CEPs
2
registered plants
17
filings across 2 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
PUNE, India Not on file
Chinchwad, India Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) 15 None
JFDA (JO) 2 None
EMA None 3

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $783K 8
2025 Not reported $705K 13
2024 Not reported $39K 10
2023 Not reported $1.1M 9

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 We do not publish the identity of any buyer.

Questions about Enzene Biosciences

Does Enzene Biosciences hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Enzene Biosciences. It does have 17 filings with 2 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Enzene Biosciences manufacture?
2 registered sites are on record, in India (Pune and Chinchwad). Every site is listed on this page with the register it came from.
Which regulators recognise Enzene Biosciences'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
Customs aggregates
Export values, molecule and destination counts