HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD

Overview

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 17 active FDA Type II Drug Master Files, covering ABIRATERONE ACETATE; ATROPINE SULFATE; CLADRIBINE DRUG SUBSTANCE; DEXIBUPROFEN DRUG SUBSTANCE; DEXMEDETOMIDINE DRUG SUBSTANCE; DEXMEDETOMIDINE HYDROCHLORIDE USP.

API / Drug Master Files

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD holds 17 active (17 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.

• INDOCYANINE GREEN USPActive2025-11-22
• DEXMEDETOMIDINE HYDROCHLORIDE USPActive2025-09-29
• IBUPROFEN ARGININE DRUG SUBSTANCEActive2025-05-14
• CLADRIBINE DRUG SUBSTANCEActive2024-05-10
• DEXMEDETOMIDINE DRUG SUBSTANCEActive2021-08-23
• DEXIBUPROFEN DRUG SUBSTANCEActive2020-11-09
• FLUDARABINE PHOSPHATE DRUG SUBSTANCEActive2020-04-29
• HOMATROPINE HYDROBROMIDEActive2019-09-29
• ATROPINE SULFATEActive2014-12-25
• HYOSCYAMINE SULFATEActive2014-09-02
• HOMATROPINE METHYLBROMIDEActive2014-07-28
• ABIRATERONE ACETATEActive2013-12-24
• Fludarabine Phosphate Drug SubstanceActive2007-11-12
• FLUMAZENILActive2006-08-31
• MILRINONEActive2006-08-31

Showing 15 of 17 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.