HUNAN DONGTING PHARMACEUTICAL CO LTD

Overview

HUNAN DONGTING PHARMACEUTICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 11 active FDA Type II Drug Master Files, covering 16ALPHA-HYDROXY PREDNISOLONE; 5TR; CHEMICAL INTERMEDIATE-16A-HYDROXY PREDNISOLONE; DIRITHROMYCIN; ENOXAPARIN SODIUM (NON-STERILE BULK FORM); HEPARIN SODIUM USP.

API / Drug Master Files

HUNAN DONGTING PHARMACEUTICAL CO LTD holds 11 active (13 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.

• CHEMICAL INTERMEDIATE-16A-HYDROXY PREDNISOLONEActive2026-02-13
• NORGESTRELActive2025-04-03
• TAFAMIDIS MEGLUMINE DRUG SUBSTANCEActive2025-01-06
• LEVONORGESTRELActive2022-09-13
• SULFADIAZINE USPActive2018-12-13
• 5TRActive2017-05-24
• 16ALPHA-HYDROXY PREDNISOLONEActive2013-07-19
• HEPARIN SODIUM USPActive2009-03-25
• DIRITHROMYCINActive2007-04-30
• ENOXAPARIN SODIUM (NON-STERILE BULK FORM)Active2005-05-28
• TRANEXAMIC ACIDActive1999-05-28
• MOMETASONE FUROATEInactive2012-03-01
• DALTEPARIN SODIUM USPInactive2007-09-25

FDA compliance signals

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