Kemwell Biopharma’s drug-product manufacturing facility in Bengaluru has received clearance from the US Food and Drug Administration (FDA) for the commercial manufacturing and testing of injectable products intended for the US market, following the successful completion of a pre-approval inspection (PAI).

This milestone marks the approval of the first product from Kemwell’s Bengaluru site to get US FDA clearance for commercial supply since the facility became a dedicated biologics campus eight years ago.

“Achieving FDA clearance for commercial manufacturing from our Bengaluru site marks a defining moment in Kemwell’s growth journey. It reflects our team’s steadfast focus on quality, compliance, and scientific excellence,” said Anurag Bagaria, Chairman and CEO, Kemwell Biopharma. 

The inspection followed a product technology transfer from Cipla.

“Our partnership with Kemwell aligns with Cipla’s strategy of building a resilient and globally trusted supply chain. The successful completion of the FDA inspection at Kemwell’s Bengaluru site reinforces our commitment to delivering safe, high-quality medicines to patients in regulated markets,” said Pradeep Bhadauria, Chief Scientific Officer, Cipla.

Kemwell’s FDA-approved site features advanced single-use and stainless-steel bioreactors, with over 5000L+ of installed upstream capacity, commercial fill-finish lines for liquid and lyophilised vials, and pre-filled syringe systems equipped with isolator technology for enhanced sterility assurance. In addition to drug-product (DP) manufacturing, the site supports process development, analytical testing, and drug-substance (DS) production—enabling fully integrated biologics programs from cell-line to commercial supply.

Headquartered in Bengaluru, Kemwell Biopharma is a leading biologics contract development and manufacturing organisation (CDMO) offering fully integrated services across cell-line development, process and analytical development, formulation, drug substance, and sterile drug product manufacturing for both novel biologics and biosimilars.