Otsuka Pharmaceutical Co., Ltd.
Overview
Otsuka Pharmaceutical Co., Ltd. is a Japanese multinational pharmaceutical company specializing in the development and commercialization of innovative drugs. The company is known for its research in areas such as immunology, nephrology, and oncology.
Therapeutic areas
API / Drug Master Files
Otsuka Pharmaceutical Co., Ltd. holds 1 active (13 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.
- OPA-15406 DRUG SUBSTANCEActive2016-05-23
- REBAMIPIDE(OPC-12759) DRUG SUBSTANCEInactive2000-08-10
- NO-1886 DRUG SUBSTANCEInactive1998-10-15
- NADIFLOXACIN DRUG SUBSTANCEInactive1997-03-01
- FORMULATION RESEARCH INSTITUTE IN TOKUSHIMA, JAPANInactive1993-05-20
- COMMERCIAL BULK PLANT OF SECOND TOKUSHIMA FACTORY IN TOKUSHIMA, JAPANInactive1992-10-05
- FACILITIES AND OPERATING PROCEDURES AT THE SAGA FACTORY, JAPANInactive1992-08-21
- MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOKUSHIMA, JAPAN.Inactive1992-01-10
- MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOKUSHIMA, JAPAN.Inactive1985-11-07
- MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOKUSHIMA, JAPAN.Inactive1985-11-07
- PROCATEROL, AEROSOL FORMULATION PRODUCED IN TOKUSHIMA FACTORYInactive1983-01-17
- PROCATEROL HYDROCHLORIDE HEMIHYDRATEInactive1979-09-19
- CARTEOLOL HCLInactive1976-05-13
FDA compliance signals
33 FDA enforcement records linked to this company.
- 4832025-06-17
Absence of Written Procedures
- 4832025-06-17
Environmental Monitoring System
- 4832025-06-17
Scientifically sound laboratory controls
- 4832025-06-17
Validation lacking for sterile drug products
- 4832019-10-22
Investigations of discrepancies, failures
- 4832019-10-22
Written procedures followed
- 4832019-10-22
Written record of complaint to include findings, follow-up
- 4832019-10-22
Annual visual exams of drug products
- 4832019-10-22
Cleaning / Sanitizing / Maintenance
- 4832019-10-22
Computer control of master formula records
- 4832019-10-22
Procedures not in writing, fully followed
- 4832019-02-15
Cleaning / Sanitizing / Maintenance
- 4832019-02-15
Control procedures to monitor and validate performance
- 4832019-02-15
Following/documenting laboratory controls
- 4832019-02-15
Written procedures not established/followed
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