Milestone expands India’s role in global biologics manufacturing; collaboration with Cipla underscores commitment to quality and reliability

Kemwell Biopharma Pvt Ltd (“Kemwell”), a leading global biologics Contract Development and Manufacturing Organization (CDMO), announced today that its drug-product manufacturing facility in Bengaluru has successfully 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.

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.

“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.”

The inspection was conducted as part of a Pre-Approval Inspection (PAI) following a product technology transfer 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.

"Our partnership with Kemwell aligns with Cipla’s strategy of building a resilient and globally trusted supply chain,” said Pradeep Bhadauria, Chief Scientific Officer, Cipla Limited. “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.”

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 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, positioning Kemwell as a trusted partner for global biopharma companies pursuing regulated-market approvals.

This achievement further strengthens Kemwell’s strategy to expand capacity, invest in advanced manufacturing technologies, and deliver compliant, scalable solutions that meet the evolving needs of the biologics industry in the United States and around the world.

About Kemwell Biopharma

Kemwell Biopharma Pvt Ltd is a leading biologics CDMO headquartered in Bengaluru, India, offering fully integrated services spanning cell-line development, process and analytical development, formulation, drug substance, and sterile drug product manufacturing for both novel biologics and biosimilars. Kemwell enables seamless technology transfer, validation, and scale-up across development, clinical, and commercial supply.

With more than 45 years of manufacturing excellence and regulatory accreditations including U.S. FDA, Indian FDA, CDSCO (Central Drugs Standard Control Organization), Malaysia NPRA (PIC/S), and recent Qualified Person (QP) audits, Kemwell partners with global pharmaceutical and biotech innovators to accelerate development and reduce time-to-market for biologics.

About Cipla Limited

Established in 1935, Cipla Limited is a global pharmaceutical company headquartered in Mumbai, India, with a strong presence across India, South Africa, North America, and other regulated and emerging markets. The company’s portfolio spans more than 1,500 products across key therapeutic areas including respiratory, urology, cardiology, and anti-infectives. Guided by its purpose of “Caring for Life,” Cipla continues to deliver affordable, high-quality medicines to patients worldwide.

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“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