YUNNAN HANDE BIO-TECH CO LTD

Overview

YUNNAN HANDE BIO-TECH CO LTD is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering 10-DEACETYLBACCATIN III; PACLITAXEL DRUG SUBSTANCE; PACLITAXEL DRUG SUBSTANCE ISOLATED FROM TAXUS CANADENSIS; PACLITAXEL DRUG SUBSTANCE, SEMI-SYNTHESIZED FROM 10-DAB; SEMI SYNTHETIC PACLITAXEL DRUG SUBSTANCE.

API / Drug Master Files

YUNNAN HANDE BIO-TECH CO LTD holds 5 active (5 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.

• 10-DEACETYLBACCATIN IIIActive2021-09-23
• PACLITAXEL DRUG SUBSTANCE, SEMI-SYNTHESIZED FROM 10-DABActive2013-09-22
• SEMI SYNTHETIC PACLITAXEL DRUG SUBSTANCEActive2009-06-01
• PACLITAXEL DRUG SUBSTANCE ISOLATED FROM TAXUS CANADENSISActive2006-01-12
• PACLITAXEL DRUG SUBSTANCEActive1996-03-29

FDA compliance signals

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