Biological E. Limited’s (BE) Injectable Facility at Shamirpet has received an EIR from USFDA!

Biological E. Limited’s (BE) Injectable Facility at Shamirpet has received an EIR from USFDA!

Biological E. Limited’s (BE) Injectable Facility at Shamirpet received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) on June 15, 2023. The EIR was issued for the most recent inspection conducted by the USFDA between January 31 and February 8, 2023.

This state-of-the-art injectable facility at Shamirpet is designed to the highest quality standards and adheres to international regulations with advanced technology and equipment. This facility has both Drug Substance (DS) and Drug Product (DP) manufacturing capabilities and offers a wide range of services such as DP capabilities in pen device, pre-filled syringes, liquid, and lyophilized vials. It has also proven technical expertise and capabilities to manufacture products, which meet world-class cGMP, regulatory, and quality systems.

Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics.