Hanmi Pharmaceutical Co., Ltd.

Overview

Hanmi Pharmaceutical Co., Ltd. is a South Korean pharmaceutical company specializing in the development of innovative drugs and healthcare solutions. It focuses on research and development in various therapeutic areas, aiming to provide global solutions for serious health challenges.

Therapeutic areas

API / Drug Master Files

Hanmi Pharmaceutical Co., Ltd. holds 32 active (44 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.

• ETELCALCETIDE HYDROCHLORIDEActive2026-03-13
• RETATRUTIDE, NON-STERILE DRUG SUBSTANCEActive2026-02-10
• DIFELIKEFALIN ACETATE, NON-STERILE BULK DRUG SUBSTANCEActive2025-12-30
• PLECANATIDEActive2025-06-26
• DEGARELIX ACETATE, NON-STERILE DRUG SUBSTANCEActive2025-03-31
• SEMAGLUTIDE, RECOMBIANANT NON-STERILE DRUG SUBSTANCEActive2024-09-24
• SEMAGLUTIDE NON-STERILE DRUG SUBSTANCEActive2024-08-08
• TIRZEPATIDE, NON-STERILE DRUG SUBSTANCEActive2024-06-27
• ABALOPARATIDE, NON-STERILE BULK DRUG SUBSTANCEActive2023-11-30
• CANNABIDIOL NON-STERILE DRUG SUBSTANCEActive2023-11-28
• DEGARELIX ACETATE, NON-STERILE DRUG SUBSTANCEActive2023-09-27
• SEMAGLUTIDE, NON-STERILE DRUG SUBSTANCEActive2023-06-09
• LINACLOTIDE NON-STERILE DRUG SUBSTANCEActive2022-08-17
• CETRORELIX ACETATE, NON-STERILE DRUG SUBSTANCEActive2022-04-29
• TERIPARATIDE, NON STERILE BULK DRUG SUBSTANCEActive2021-12-29

Showing 15 of 44 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Hanmi Pharmaceutical Co., Ltd. in our records. PharmaTek screens the full directory against live FDA enforcement data.