SHANDONG XINHUA PHARMACEUTICAL CO LTD

Overview

SHANDONG XINHUA PHARMACEUTICAL CO LTD is an active pharmaceutical ingredient (API) supplier with 160 active FDA Type II Drug Master Files, covering 16 ALPHA-METHYL EPOXIDE (8-DM); 16 ALPHA-METHYL EPOXIDE (8DM); ABEMACICLIB; ABIRATERONE ACETATE; ABIRATERONE ACETATE (NON-STERILE); AFATINIB DIMALEATE.

API / Drug Master Files

SHANDONG XINHUA PHARMACEUTICAL CO LTD holds 160 active (176 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.

• DOTINURADActive2026-03-25
• RELUGOLIXActive2026-03-25
• GLYCOPYRRONIUM BROMIDEActive2026-03-23
• VONOPRAZAN FUMARATEActive2026-03-23
• DAPOXETINE HYDROCHLORIDEActive2026-03-23
• AZILSARTAN MEDOXOMIL POTASSIUMActive2026-03-13
• ATOMOXETINE HYDROCHLORIDEActive2026-03-13
• FEZOLINETANTActive2026-02-26
• ELAGOLIX SODIUMActive2026-02-26
• RESMETIROMActive2026-02-26
• LENACAPAVIR INTERMEDIATE (LEP3)Active2026-01-30
• ERTUGLIFLOZIN L-PYROGLUTAMIC ACIDActive2026-01-21
• HEPARIN SODIUMActive2026-01-20
• FLUVOXAMINE MALEATEActive2025-12-26
• DAPRODUSTATActive2025-12-23

Showing 15 of 176 Drug Master Files.

FDA compliance signals

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