STERLING CHEMICAL MALTA LTD

Overview

STERLING CHEMICAL MALTA LTD is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering ABIRATERONE ACETATE; DUTASTERIDE FORM I; LEVONORGESTREL; UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE.

Core services & business areas

API / Drug Master Files

STERLING CHEMICAL MALTA LTD holds 5 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.

• VILANTEROL TRIFENATATEActive2024-04-15
• UMECLIDINIUM BROMIDEActive2024-04-15
• DUTASTERIDE FORM IActive2015-12-23
• LEVONORGESTRELActive2014-08-05
• ABIRATERONE ACETATEActive2014-02-12

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to STERLING CHEMICAL MALTA LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.