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.

API / Drug Master Files

HISAMITSU PHARMACEUTICAL CO INC holds 3 active (4 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-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

No FDA recalls, Warning Letters, or Form 483 observations are linked to HISAMITSU PHARMACEUTICAL CO INC in our records. PharmaTek screens the full directory against live FDA enforcement data.