Nippon Shinyaku Co., Ltd.

Overview

Nippon Shinyaku Co., Ltd. is a pharmaceutical company engaged in the research, development, and production of a wide range of medicinal products. With a focus on therapeutic areas such as oncology, hematology, and cardiovascular diseases, the company aims to deliver innovative solutions to enhance patient care.

Therapeutic areas

API / Drug Master Files

Nippon Shinyaku Co., Ltd. holds 0 active (3 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.

• NS-065/NCNP-01Inactive2015-10-29
• NS-018 ACTIVE DRUG SUBSTANCEInactive2012-01-25
• NS-49Inactive1999-02-23

FDA compliance signals

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