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.

API / Drug Master Files

JUBILANT BIOSYS LTD holds 93 active (93 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.

• HISTAMINE DIHYDROCHLORIDEActive2021-03-31
• APREMILASTActive2020-01-17
• VILAZODONE HYDROCHLORIDEActive2019-07-27
• MIRABEGRONActive2019-07-27
• BREXPIPRAZOLEActive2018-12-31
• VILDAGLIPTINActive2018-03-30
• TICAGRELORActive2018-03-30
• VARENICLINE TARTRATEActive2018-03-30
• PIRFENIDONEActive2018-01-24
• APIXABANActive2017-11-30
• NIACIN USPActive2017-03-29
• PERPHENAZINE USPActive2017-03-29
• DABIGATRAN ETEXILATE MESYLATEActive2017-03-27
• LURASIDONE HYDROCHLORIDEActive2017-03-27
• RIVAROXABANActive2017-03-23

Showing 15 of 93 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.