Alkaloida Chemical Company Zrt.

Overview

Alkaloida Chemical Company Zrt. is a pharmaceutical company based in Hungary. It specializes in the production of active pharmaceutical ingredients and provides various services related to drug development. It is a subsidiary of Sun Pharmaceutical Industries Ltd.

Therapeutic areas

API / Drug Master Files

Alkaloida Chemical Company Zrt. holds 3 active (6 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.

• PHENOBARBITAL SODIUM, USPActive2020-03-10
• HYDROXYCHLOROQUINE SULFATE USPActive2010-03-25
• PHENOBARBITAL USPActive1982-09-01
• TOPIRAMATEInactive2003-01-30
• BUSPIRONE HYDROCHLORIDEInactive1996-10-16
• BUSPIRONE BASEInactive1996-09-16

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Alkaloida Chemical Company Zrt. in our records. PharmaTek screens the full directory against live FDA enforcement data.