Kemwell Biopharma (Kemwell), a global biologics Contract Development and Manufacturing Organization (CDMO), announced that its drug-product manufacturing facility in Bengaluru has completed a U.S. Food and Drug Administration (FDA) pre-approval inspection (PAI) and is now cleared for the commercial manufacturing and testing of injectable products destined for the U.S. market.

The inspection was conducted as part of a Pre-Approval Inspection (PAI) following the transfer of product technology from Cipla Limited, a leading global pharmaceutical company. 

The outcome underscores the confidence that major pharmaceutical innovators place in Kemwell’s capabilities and the reliability of its manufacturing network.

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

It demonstrates the company’s ability to meet stringent current Good Manufacturing Practice (cGMP) and aseptic drug-product manufacturing standards.

Kemwell’s FDA-approved site features single-use and stainless-steel bioreactors, with over 5000L+ of installed upstream capacity, commercial fill-finish lines for liquid and lyophilized 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.

The company’s services span a wide spectrum of biologic modalities—including Monoclonal Antibodies, recombinant proteins, bispecific and trispecific antibodies, biosimilars, and New Biological Entities—and extend to advanced therapies with cGMP cell-therapy development and manufacturing capabilities.

“Achieving FDA clearance for commercial manufacturing from our Bengaluru site marks a defining moment in Kemwell’s growth journey,” said Anurag Bagaria, Chairman and CEO, Kemwell Biopharma. “It reflects our team’s steadfast focus on quality, compliance, and scientific excellence. We are proud to support our partners in accelerating the delivery of important therapies to patients in the United States and around the world.”