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.

API / Drug Master Files

ORBION PHARMACEUTICALS PRIVATE LTD holds 48 active (48 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.

• PANTOPRAZOLE SODIUM USPActive2025-12-26
• ALBENDAZOLE USPActive2021-02-12
• APIXABANActive2020-10-08
• DABIGATRAN ETEXILATE MESYLATEActive2020-09-28
• 5,6-DIHYDRO-3-(4-MORPHOLINYL)-1-[4-(2-OXO-1-PIPERIDINYL)PHENYL]-2(1H)-PYRIDINONE (AXBN20)Active2020-04-27
• HYDROXYCHLOROQUINE SULFATE USPActive2020-03-26
• SAFINAMIDE MESYLATEActive2020-02-13
• LABETALOL HYDROCHLORIDE USPActive2019-08-29
• RIVAROXABANActive2019-07-06
• ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USPActive2018-06-30
• DEXTROMETHORPHAN HYDROBROMIDE USPActive2018-06-04
• ALCAFTADINEActive2018-01-07
• PENICILLAMINE, USPActive2016-10-18
• PERPHENAZINE USPActive2012-11-28
• RISEDRONATE SODIUMActive2012-03-01

Showing 15 of 48 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to ORBION PHARMACEUTICALS PRIVATE LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.