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

Active ingredients with DMF or CEP filings

Substances for which STERLING CHEMICAL MALTA LTD holds, or has held, a US FDA Drug Master File or an EU CEP. A filing is not proof of current supply. Open any ingredient to see all its holders, CAS number and product patent dates.

API / Drug Master Files

STERLING CHEMICAL MALTA LTD holds 5 active (5 total) FDA Type II Drug Master Files. A Type II DMF is filed with the FDA to support an active ingredient in drug applications; an active filing can be referenced but is not proof of current supply, and inactive filings are historical.

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

Registered manufacturing sites (1)

Physical sites registered with the US FDA and resolved to STERLING CHEMICAL MALTA LTD, with any EU/UK GMP documents matched to each site. Headquarters and manufacturing locations can differ.

• Sterling Chemical Malta Ltd
  Birzebbuga, Malta · API manufacture
  Site GMP match

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to STERLING CHEMICAL MALTA LTD in our records. Events are linked by company name and identifier, so this is not proof that none exist; check the FDA's own databases before relying on it.