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).

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.