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
Active pharmaceutical ingredients supplied
Substances Otsuka 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
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
Environmental Monitoring System
- 4832025-06-17
Scientifically sound laboratory controls
- 4832025-06-17
Validation lacking for sterile drug products
- 4832025-06-17
Absence of Written Procedures
- 4832019-10-22
Investigations of discrepancies, failures
- 4832019-10-22
Annual visual exams of drug products
- 4832019-10-22
Procedures not in writing, fully followed
- 4832019-10-22
Cleaning / Sanitizing / Maintenance
- 4832019-10-22
Computer control of master formula records
- 4832019-10-22
Written record of complaint to include findings, follow-up
- 4832019-10-22
Written procedures followed
- 4832019-02-15
Control procedures to monitor and validate performance
- 4832019-02-15
Cleaning / Sanitizing / Maintenance
- 4832019-02-15
Following/documenting laboratory controls
- 4832019-02-15
Written procedures not established/followed
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