HISAMITSU PHARMACEUTICAL CO INC
Overview
HISAMITSU PHARMACEUTICAL CO INC is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering HP-3070 TRANSDERMAL SYSTEM; HP-3150 TRANSDERMAL SYSTEM; HP-5000, TOPICAL PATCH.
Core services & business areas
API / Drug Master Files
HISAMITSU PHARMACEUTICAL CO INC holds 4 active (5 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.
- HP-6050 MICRONEEDLE TRANSDERMAL SYSTEMActive2026-06-30
- HP-3150 TRANSDERMAL SYSTEMActive2024-10-11
- HP-5000, TOPICAL PATCHActive2016-11-04
- HP-3070 TRANSDERMAL SYSTEMActive2016-01-15
- MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TOKYO, JAPAN.Inactive1991-07-16
FDA compliance signals
22 FDA enforcement records linked to this company.
- 4832025-07-11
Cleaning / Sanitizing / Maintenance
- 4832025-07-11
Scientifically sound laboratory controls
- 4832025-07-11
Testing and standardization of standards et. al.
- 4832025-07-11
Investigations of discrepancies, failures
- 4832025-07-11
Valid stability test methods
- 4832025-07-04
Scientifically sound laboratory controls
- 4832025-07-04
Investigations of discrepancies, failures
- 4832025-07-04
Absence of Written Procedures
- 4832019-10-11
Test methods
- 4832019-10-11
Procedure Deviations Recorded and Justified
- 4832019-10-11
No written record of investigation
- 4832019-10-11
Cleaning / Sanitizing / Maintenance
- 4832019-10-11
Investigations of discrepancies, failures
- 4832017-09-15
Equipment for Environmental Control
- 4832017-09-15
Prepared for each batch, include complete information
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