Chugai Pharmaceutical Co., Ltd.

Overview

Chugai Pharmaceutical Co., Ltd. is a leading Japanese pharmaceutical company focused on the research and development of innovative medicines. It operates as a subsidiary of the Roche Group, utilizing its global resources while maintaining its operational independence to develop novel therapies mainly in the oncology and inflammation fields.

Therapeutic areas

API / Drug Master Files

Chugai Pharmaceutical Co., Ltd. holds 6 active (11 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.

• RIFABUTIN (USP)Active2024-02-06
• RIFAMYCIN SODIUM (EP)Active2021-11-15
• RIFAXIMIN (EP)Active2021-09-27
• RIFAMYCIN S (PURIFIED)Active2021-08-10
• RIFAMYCIN SActive2021-07-22
• GRISEOFULVIN, USPActive2005-02-02
• OCT (MAXACALCITOL)Inactive1998-03-26
• CCA (LOBENZARIT SODIUM) TABLETSInactive1987-11-02
• CCA (LOBENZARIT SODIUM) BULK DRUGInactive1987-11-02
• SG-75 (NICORANDIL) BULK DRUG PRODUCTInactive1986-12-11
• SG-75 (N-(2-HYDROXYETHYL) NICOTINAMIDE NITRATE TABSInactive1981-04-01

FDA compliance signals

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