Suppliers / "Opes Healthcare

"Opes Healthcare

India Updated 9 July 2026

"Opes Healthcare is a finished-dose manufacturer based in India. It appears in 73 regulatory filings across 3 regulators, without an active US DMF or CEP on file. Its filings concentrate with ARCSA (EC), UZPHARM (UZ) and MINSA (CR). Its GMP standing is certified by CDSCO (India) and UZPHARM (UZ). Customs aggregates show $4.3M of exports covering 369 molecules to 10 destinations in 2025.

0
active US DMFs
0
valid CEPs
1
registered plants
73
filings across 3 regulators

Registered plants

Site FDA FEI
Vadodara, India Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 41 None
UZPHARM (UZ) 17 1
MINSA (CR) 15 None
CDSCO (India) None 2

Scale

Year Revenue Exports Destinations
2025 Not reported $4.3M 10
2024 Not reported $5.5M 10
2023 Not reported $4.3M 10
2022 Not reported $3.4M 9

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 We do not publish the identity of any buyer.

Questions about "Opes Healthcare

Does "Opes Healthcare hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for "Opes Healthcare. It does have 73 filings with 3 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does "Opes Healthcare manufacture?
1 registered site is on record, in India (Vadodara). Every site is listed on this page with the register it came from.
Which regulators recognise "Opes Healthcare's GMP?
Current GMP certificates are on record from CDSCO (India) and UZPHARM (UZ). 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