ATUL BIOSCIENCE LTD

Overview

ATUL BIOSCIENCE LTD is an active pharmaceutical ingredient (API) supplier with 11 active FDA Type II Drug Master Files, covering (4-[2-(DIMETHYLAMINO)-1-(1-HYDROXYCYCLOHEXYL) ETHYL] PHENOL; 2-BUTYL-4-CHLORO-1-[P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL]IMIDAZOLE-5-METHANOL; ACYCLOVIR USP; DESVENLAFAXINE SUCCINATE USP; FLUCONAZOLE; LOSARTAN POTASSIUM USP.

API / Drug Master Files

ATUL BIOSCIENCE LTD holds 11 active (11 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.

• METOPROLOL TARTRATE USPActive2025-11-14
• METOPROLOL SUCCINATE USPActive2025-06-30
• VALACYCLOVIR HYDROCHLORIDE USPActive2025-03-25
• ACYCLOVIR USPActive2025-03-25
• FLUCONAZOLEActive2024-11-15
• 2-BUTYL-4-CHLORO-1-[P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL]IMIDAZOLE-5-METHANOLActive2023-03-28
• (4-[2-(DIMETHYLAMINO)-1-(1-HYDROXYCYCLOHEXYL) ETHYL] PHENOLActive2023-02-01
• LOSARTAN POTASSIUM USPActive2022-12-29
• DESVENLAFAXINE SUCCINATE USPActive2022-11-09
• VENLAFAXINE HYDROCHLORIDEActive2022-07-20
• N-(BENZYLOXYCARBONYL)-L-VALINEActive2018-01-24

FDA compliance signals

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