Suppliers / Agio Pharmaceuticals

Agio Pharmaceuticals

India 362 employees Updated 9 July 2026

Agio Pharmaceuticals is a finished-dose manufacturer based in India. It appears in 87 regulatory filings across 11 regulators, without an active US DMF or CEP on file. Its filings concentrate with UZPHARM (UZ), DIGEMAPS (DO) and RAMA (GE). Its GMP standing is certified by CDSCO (India), UZPHARM (UZ) and FDA (GH). Customs aggregates show $25.9M of exports covering 1,204 molecules to 25 destinations in 2025.

0
active US DMFs
0
valid CEPs
6
registered plants
87
filings across 11 regulators

Registered plants

Site FDA FEI
Surendranagar, United Arab Emirates Not on file
Pune, United Arab Emirates Not on file
vapivapi 396 195valsad, India Not on file
surendranagar, India Not on file
G.I.D.C., India Not on file
japur highwaydedhrota 383 220sabarkantha, India Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
UZPHARM (UZ) 49 1
DIGEMAPS (DO) 8 None
RAMA (GE) 7 None
EDE (AE) 6 None
MINSA (CR) 6 None
US FDA 4 None
CDSCO (India) None 5
FDA (GH) None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $5.5M 11
2025 Not reported $25.9M 25
2024 Not reported $24.3M 23
2023 Not reported $24.2M 20

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 We do not publish the identity of any buyer.

Questions about Agio Pharmaceuticals

Does Agio Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Agio Pharmaceuticals. It does have 87 filings with 11 regulators, so it is registered, just not with the two strong registers buyers usually screen on.
Where does Agio Pharmaceuticals manufacture?
6 registered sites are on record, in United Arab Emirates and India (Surendranagar, Pune and Vapivapi 396 195valsad among others). Every site is listed on this page with the register it came from.
Which regulators recognise Agio Pharmaceuticals's GMP?
Current GMP certificates are on record from CDSCO (India), UZPHARM (UZ) and FDA (GH). 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