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

What they file, and where

Molecule Regulators Docs
Modafinil EDQM, US FDA 2
Amlodipine US FDA 1
Aripiprazole US FDA 1
Cetirizine US FDA 1
Desloratadine US FDA 1
Duloxetine US FDA 1
Eszopiclone US FDA 1
Felodipine US FDA 1
Gemifloxacin US FDA 1
Granisetron US FDA 1
Show all 29 molecules on file
Granisetron Hydrochloride EDQM 1
Ibandronate US FDA 1
Levetiracetam US FDA 1
Levofloxacin US FDA 1
Memantine US FDA 1
Naratriptan US FDA 1
Olanzapine US FDA 1
Pantoprazole US FDA 1
Pramipexole US FDA 1
Quetiapine US FDA 1
Rasagiline US FDA 1
Risedronic Acid US FDA 1
Rivastigmine US FDA 1
Ropinirole US FDA 1
Sumatriptan US FDA 1
Terbinafine US FDA 1
Venlafaxine US FDA 1
Zaleplon US FDA 1
Zolmitriptan US FDA 1

Also appears on these molecule pages

Amlodipine API Cetirizine API Desloratadine API Duloxetine API Felodipine API Ibandronic Acid API Levofloxacin API Memantine API Olanzapine API Pramipexole API Sumatriptan API Terbinafine API
Show 5 more molecule pages
Zolmitriptan API Quetiapine API Venlafaxine API Pantoprazole API Levetiracetam API

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 We do not publish the identity of any buyer.

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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