STERLING BIOTECH LTD
Overview
STERLING BIOTECH LTD is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering DOXORUBICIN HYDROCHLORIDE(API); LOVASTATIN(API).
Core services & business areas
Active pharmaceutical ingredients supplied
Substances STERLING BIOTECH LTD is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
STERLING BIOTECH LTD holds 2 active (4 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.
- LOVASTATIN(API)Active2011-04-07
- DOXORUBICIN HYDROCHLORIDE(API)Active2011-04-05
- SIMVASTATIN USPInactive2016-07-20
- SIMVASTATIN AMMONIUM SALT (INTERMEDIATE)Inactive2016-07-18
FDA compliance signals
No FDA recalls, Warning Letters, or Form 483 observations are linked to STERLING BIOTECH LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.
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