Brooks Lab's subsidiary receives USFDA approval for Meropenem Injection; Stock zooms 5%

23 Aug 2022 , 09:17 AM

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

This USFDA approval marks Brooks’ foray into the US market, which is the largest generic market in the World. Brooks manufactures its carbapenem range of injectables at its dedicated facility situated at Vadodara, India. 

Further, the facility is approved by several regulatory agencies which includes the European Union, and it is equipped to produce a wide range of products meeting global quality standards as well.

Meropenem Injection is an intravenous beta-lactam antibiotic which is used to treat various bacteria related infections. It is indicated for treating complicated skin-based 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 US$ 78 million for the 12 months ending June 2022, according to IIQVIA data.  In May 2022, BSL also received the marketing authorization for Meropenem injections in the United Kingdom (UK) and European Union. As on June  2022, Global Penem market is US$ 2.6 billion.

At around 9:17 AM, Brooks Laboratories was trading at Rs110.30 per share up by Rs5.25 or 5% from its previous closing of Rs105.05 per share on the BSE.