JUBILANT BIOSYS LTD

Overview

JUBILANT BIOSYS LTD is an active pharmaceutical ingredient (API) supplier with 93 active FDA Type II Drug Master Files, covering ALENDRONATE SODIUM USP; ALISKIREN HEMIFUMARATE; APIXABAN; APREMILAST; APREPITANT USP; ARIPIPRAZOLE USP.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances JUBILANT BIOSYS 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

JUBILANT BIOSYS LTD holds 95 active (95 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.

• CARBAMAZEPINE USPActive2026-06-20
• HISTAMINE DIHYDROCHLORIDEActive2021-03-31
• APREMILASTActive2020-01-17
• VILAZODONE HYDROCHLORIDEActive2019-07-27
• MIRABEGRONActive2019-07-27
• BREXPIPRAZOLEActive2018-12-31
• VILDAGLIPTINActive2018-03-30
• VARENICLINE TARTRATEActive2018-03-30
• TICAGRELORActive2018-03-30
• PIRFENIDONEActive2018-01-24
• APIXABANActive2017-11-30
• PERPHENAZINE USPActive2017-03-29
• NIACIN USPActive2017-03-29
• LURASIDONE HYDROCHLORIDEActive2017-03-27
• DABIGATRAN ETEXILATE MESYLATEActive2017-03-27

Showing 15 of 95 Drug Master Files.

FDA compliance signals

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