ORBION PHARMACEUTICALS PRIVATE LTD
Overview
ORBION PHARMACEUTICALS PRIVATE LTD is an active pharmaceutical ingredient (API) supplier with 48 active FDA Type II Drug Master Files, covering 5,6-DIHYDRO-3-(4-MORPHOLINYL)-1-[4-(2-OXO-1-PIPERIDINYL)PHENYL]-2(1H)-PYRIDINONE (AXBN20); ALBENDAZOLE USP; ALCAFTADINE; AMLODIPINE BESYLATE; AMLODIPINE BESYLATE USP; APIXABAN.
Core services & business areas
Active pharmaceutical ingredients supplied
Substances ORBION PHARMACEUTICALS PRIVATE LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
ORBION PHARMACEUTICALS PRIVATE LTD holds 30 active (30 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- RISEDRONATE SODIUMActive2012-03-01
- ZOLMITRIPTANActive2011-09-16
- OLANZAPINEActive2010-08-11
- ISA (INTERMEDIATE)Active2010-06-28
- RASAGILINE MESYLATE (NON STERILE BULK API)Active2010-05-07
- LEVOFLOXACIN (NON-STRILE BULK API)Active2010-03-30
- QUETIAPINE FUMARATE (NON STERILE BULK API)Active2009-12-24
- PRAMIPEXOLE DIHYDROCHLORIDEActive2009-08-28
- NARATRIPTAN HYDROCHLORIDE (NON-STERILE BULK API)Active2008-12-12
- ESZOPICLONE (NON-STERILE BULK API)Active2008-11-27
- PANTOPRAZOLE SODIUM (NON-STERILE BULK API)Active2008-11-12
- ROPINIROLE HYDROCHLORIDE (NON-STERILE BULK API)Active2008-10-18
- ARIPIPRAZOLE (NON-STERILE BULK API)Active2008-09-20
- DULOXETINE HYDROCHLORIDE (NON-STERILE BULK API)Active2008-06-27
- FELODIPINE (NON-STERILE BULK API)Active2008-04-02
Showing 15 of 30 Drug Master Files.
FDA compliance signals
8 FDA enforcement records linked to this company.
- 4832023-09-08
Equipment Design, Size and Location
- 4832023-09-08
Absence of Written Procedures
- 4832023-09-08
Following/documenting laboratory controls
- 4832019-05-31
Tablet or capsule weight variation
- 4832019-05-31
Procedures for non-sterile drug products
- 4832019-05-31
Scientifically sound laboratory controls
- 4832019-05-31
Equipment for Environmental Control
- 4832019-05-31
Test methods
Is this ORBION PHARMACEUTICALS PRIVATE LTD? Get in front of buyers actively sourcing.
We route real sourcing requests from pharma buyers to vetted, verified partners — qualified leads, not just a listing. Tell us what you make and we'll be in touch about becoming a Verified Supplier Partner.
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 7 days.