Suppliers / Orbion Pharmaceuticals

Orbion Pharmaceuticals

India Updated 9 July 2026

Orbion Pharmaceuticals is an API manufacturer based in India. It holds 28 active US drug master files and 2 valid CEPs across a filed portfolio of 29 molecules. Its GMP standing is certified by CDSCO (India), MHRA (UK) and EMA. Customs aggregates show $27.8M of exports covering 899 molecules to 7 destinations in 2025.

28
active US DMFs
2
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
Irungattukottai, India Not on file
SRIPERUMBUDUR, India Not on file
Kanchipuram, India Not on file

Filings and GMP by regulator

Regulator Filings GMP certificates
CDSCO (India) None 2
MHRA (UK) None 1
EMA None 1

Scale

Year Revenue Exports Destinations
2026 YTD Not reported $5.4M 1
2025 Not reported $27.8M 7
2024 Not reported $17.6M 6
2023 Not reported $13.2M 8

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 We do not publish the identity of any buyer.

Questions about Orbion Pharmaceuticals

Does Orbion Pharmaceuticals hold a US DMF or a CEP?
Orbion Pharmaceuticals holds 28 active US drug master files and 2 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 Orbion Pharmaceuticals manufacture?
3 registered sites are on record, in India (Irungattukottai, Sriperumbudur and Kanchipuram). Every site is listed on this page with the register it came from.
What does Orbion Pharmaceuticals make?
29 molecules are on record against Orbion Pharmaceuticals, including Modafinil, Amlodipine, Aripiprazole and Cetirizine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Orbion Pharmaceuticals's GMP?
Current GMP certificates are on record from CDSCO (India), MHRA (UK) and 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