- Kemwell Biopharma has received U.S. FDA clearance for commercial manufacturing and testing of injectable biologics at its Bengaluru facility following a successful pre-approval inspection (PAI).
- The approval follows a technology transfer from Cipla Limited and marks the first U.S. FDA-approved product from Kemwell’s dedicated biologics campus.
Kemwell Biopharma Pvt Ltd has announced that its drug-product manufacturing facility in Bengaluru, India, has successfully completed a U.S. Food and Drug Administration (FDA) pre-approval inspection (PAI) and is now authorised for the commercial manufacturing and testing of injectable products for the U.S. market.
This milestone represents the first FDA clearance for a commercial product from Kemwell’s Bengaluru biologics site since it was established eight years ago. The approval validates the company’s adherence to current Good Manufacturing Practice (cGMP) standards and reinforces its capabilities in aseptic drug-product manufacturing.
The inspection followed a technology transfer from Cipla Limited, a global pharmaceutical company. Pradeep Bhadauria, Chief Scientific Officer at Cipla, said: “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.”
“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.”
Anurag Bagaria, Chairman and Chief Executive Officer of Kemwell Biopharma
Kemwell’s FDA-approved site is equipped with over 5,000L of installed upstream capacity, advanced fill-finish lines for liquid and lyophilised vials, and pre-filled syringe systems with isolator technology. The site also supports process development, analytical testing, and drug-substance production, offering fully integrated biologics and cell-therapy manufacturing solutions for global biopharma partners.
