APICORE US LLC

Overview

APICORE US LLC is an active pharmaceutical ingredient (API) supplier with 20 active FDA Type II Drug Master Files, covering BELZUTIFAN; BEXAROTENE; BORTEZOMIB; BUSULFAN USP; CEVIMELINE HYDROCHLORIDE USP; CYCLOPHOSPHAMIDE USP (STERILE BULK).

API / Drug Master Files

APICORE US LLC holds 20 active (26 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.

• SELEGILINEActive2025-10-10
• BELZUTIFANActive2025-05-06
• FLUORESCEIN SODIUM USPActive2024-12-24
• PLERIXAFOR, USPActive2024-10-04
• FERRIC CARBOXYMALTOSEActive2024-10-01
• TIRZEPATIDEActive2024-07-27
• CEVIMELINE HYDROCHLORIDE USPActive2024-07-23
• SEMAGLUTIDEActive2024-06-29
• LURBINECTEDINActive2024-01-13
• FERUMOXYTOLActive2023-10-24
• METYROSINE, USPActive2022-09-06
• GANIRELIX ACETATEActive2022-04-28
• MTB008Active2021-07-31
• CYCLOPHOSPHAMIDE USP (STERILE BULK)Active2021-07-28
• TRABECTEDINActive2021-04-19

Showing 15 of 26 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to APICORE US LLC in our records. PharmaTek screens the full directory against live FDA enforcement data.