Brooks Laboratories’ arm gets USFDA’s nod for Meropenem Injection

22 Aug 2022 Evaluate

Brooks Laboratories’ subsidiary company -- Brooks Steriscience (BSL) has received approval for Meropenem Injection 500mg per vial and 1gram per vial (the product) from the United States Food & Drug Administration (USFDA). The product is generic equivalent to the Merrem Injection of Pfizer Inc.

This approval from USFDA marks Brooks’ foray into the US, which is the largest generic market in the World. Brooks manufactures its carbapenem range of injectables at its dedicated facility at Vadodara, India. The facility is approved by several regulatory agencies, including the European Union, and is equipped to produce a wide range of products meeting global quality standards.

Meropenem Injection is an intravenous beta-lactam antibiotic used to treat various bacterial infections. It is indicated for treating complicated skin and skin structure infections, intra-abdominal infections, and bacterial meningitis to reduce the development of drug-resistant bacteria and maintain the effectiveness of the injection and other antibacterial drugs. Meropenem has an estimated market size of $78 million for the twelve months ending June 2022. In May 2022, BSL also received the marketing authorization for Meropenem injections in the United Kingdom and European Union. Global Penem market is $2.6 billion as on June 2022.

Brooks Laboratories is a pharmaceutical contract research and manufacturing services company.

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