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.

Core services & business areas

Active pharmaceutical ingredients supplied

Substances SHANDONG XINHUA PHARMACEUTICAL CO LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.

API / Drug Master Files

SHANDONG XINHUA PHARMACEUTICAL CO LTD holds 27 active (32 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.

• LEVODOPA (II)Active2026-06-11
• BISMUTH SUBSALICYLATEActive2026-06-08
• OMEGA-3-ACID ETHYL ESTERS 90Active2025-09-11
• GLIMEPIRIDE (II)Active2024-09-04
• PREDNISOLONEActive2024-07-25
• CALCIUM POLYCARBOPHILActive2023-04-26
• HYDROCORTISONE ACETATEActive2022-12-06
• PREDNISONEActive2020-12-22
• SEVELAMER CARBONATEActive2020-11-02
• ETHYL ICOSAPENTATE 70Active2020-09-08
• ETHYL ICOSAPENTATE 98Active2020-03-10
• PREDNISONE ACETATEActive2020-02-18
• HYDROCORTISONEActive2018-10-04
• GLIMEPIRIDEActive2017-11-22
• DIPYRONE (METAMIZOLE SODIUM MONOHYDRATE)Active2016-10-19

Showing 15 of 32 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.