BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD

Overview

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD is an active pharmaceutical ingredient (API) supplier with 41 active FDA Type II Drug Master Files, covering ((3S,5R)-5-((1H-1,2,4-TRIAZOL-1-YL)METHYL)-5-(2,4-DIFLUOROPHENYL)TETRAHYDROFURAN-3-YL)METHYL 4-METHYLBENZENESULFONATE(POSACONAZOLE INTERMEDIATE POA); 2-[(1S,2S)-1-ETHY1-2-BEZYLOXYPROPYL]-2,4-DIHYDRO-4-[4-[4-(4-HYDROXYPHENYL) -1-PIPERAZINYL]PHENYL]- 3H-1,2,4-TRIAZOL-3-ONE (POSACONAZOLE INTERMEDIATE POB); 2-AMINO-1,9-DIHYDRO-9-[(1S,3R,4S)-4-(BENZYLOXY)-3-(BENZYLOXYMETHYL)-2-METHYLENE CYCLOPENTYL]-6H-PURINE-6-ONE(ET1); ANIDULAFUNGIN (NON-STERILE API); ARGATROBAN; CARBOPROST TROMETHAMINE.

API / Drug Master Files

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD holds 41 active (49 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.

• SAXAGLIPTIN INTERMEDIATE SGAActive2024-12-31
• SAXAGLIPTIN INTERMEDIATE SGBActive2024-07-21
• VOCLOSPORINActive2024-07-09
• LURBINECTEDINActive2023-12-28
• TRABECTEDINActive2023-12-13
• ISAVUCONAZONIUM SULFATEActive2023-10-19
• FIDAXOMICINActive2023-09-28
• FONDAPARINUX SODIUM USPActive2022-12-16
• DALBAVANCIN HYDROCHLORIDE (DB)Active2022-11-24
• DALBAVANCIN PRECURSOR A40926 (CBR48)Active2022-09-14
• CARBOPROST TROMETHAMINEActive2022-08-31
• MOLNUPIRAVIRActive2022-08-25
• FERRIC CARBOXYMALTOSEActive2022-07-28
• EXATECAN MESYLATEActive2022-06-24
• EVEROLIMUS (0.2%BHT)Active2021-12-31

Showing 15 of 49 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.