Sterling Pharma Solutions Limited

Overview

Sterling Pharma Solutions Limited is a leading UK-based provider of small molecule API development and manufacturing services spanning pre-clinical, clinical, and commercial stages. The company is known for its expertise in complex and hazardous chemistry, serving a broad client base that includes major pharmaceutical companies worldwide.

Therapeutic areas

API / Drug Master Files

Sterling Pharma Solutions Limited holds 2 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.

• DIROXIMEL FUMARATE DRUG SUBSTANCEActive2018-10-19
• ACRIVASTINEActive2002-02-26
• KETONE BISULFITE ADDUCT (KBA) DRUG SUBSTANCE INTERMEDIATEInactive2007-08-28

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Sterling Pharma Solutions Limited in our records. PharmaTek screens the full directory against live FDA enforcement data.