Brooks Steriscience receives USFDA approval for Meropenem Injection

Brooks Laboratories announced that its subsidiary, Brooks Steriscience 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.

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