{"id":62099,"date":"2025-10-28T07:06:37","date_gmt":"2025-10-28T06:06:37","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/kemwell-biopharma-facility-in-bengaluru-successfully-completes-u-s-fda-inspection-for-commercial-drug-product-manufacturing\/"},"modified":"2025-10-28T07:06:37","modified_gmt":"2025-10-28T06:06:37","slug":"kemwell-biopharma-facility-in-bengaluru-successfully-completes-u-s-fda-inspection-for-commercial-drug-product-manufacturing","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/kemwell-biopharma-facility-in-bengaluru-successfully-completes-u-s-fda-inspection-for-commercial-drug-product-manufacturing\/","title":{"rendered":"Kemwell Biopharma Facility in Bengaluru Successfully Completes U.S. FDA Inspection for Commercial Drug-Product Manufacturing"},"content":{"rendered":"
\n

\nMilestone expands India\u2019s role in global biologics manufacturing; collaboration with Cipla underscores commitment to quality and reliability<\/p>\n

<\/a>
<\/a><\/p>\n

BENGALURU, India–(BUSINESS WIRE)–Kemwell Biopharma Pvt Ltd (\u201cKemwell\u201d), 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.<\/p>\n

\nThis milestone marks the approval of the first product to get U.S. FDA clearance for commercial supply from Kemwell\u2019s Bengaluru drug-product facility since the site became a dedicated biologics campus eight years ago. It demonstrates the company\u2019s ability to meet stringent current Good Manufacturing Practice (cGMP) and aseptic drug-product manufacturing standards.<\/p>\n

\n\u201cAchieving FDA clearance for commercial manufacturing from our Bengaluru site marks a defining moment in Kemwell\u2019s growth journey,\u201d said Anurag Bagaria, Chairman and CEO, Kemwell Biopharma. \u201cIt reflects our team\u2019s 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.\u201d<\/p>\n

\nThe 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\u2019s capabilities and the reliability of its manufacturing network.<\/p>\n

\n“Our partnership with Kemwell aligns with Cipla\u2019s strategy of building a resilient and globally trusted supply chain,\u201d said Pradeep Bhadauria, Chief Scientific Officer, Cipla Limited. \u201cThe successful completion of the FDA inspection at Kemwell\u2019s Bengaluru site reinforces our commitment to delivering safe, high-quality medicines to patients in regulated markets.\u201d<\/p>\n

\nKemwell\u2019s 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\u2014enabling fully integrated biologics programs from cell-line to commercial supply.<\/p>\n

\nThe company\u2019s services span a wide spectrum of biologic modalities\u2014including Monoclonal Antibodies, recombinant proteins, bispecific and trispecific antibodies, biosimilars and New Biological Entities\u2014and 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.<\/p>\n

\nThis achievement further strengthens Kemwell\u2019s 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.<\/p>\n

\nAbout Kemwell Biopharma<\/b><\/p>\n

\nKemwell 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.<\/p>\n

\nWith 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.<\/p>\n

\nAbout Cipla Limited<\/b><\/p>\n

\nEstablished 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\u2019s portfolio spans more than 1,500 products across key therapeutic areas including respiratory, urology, cardiology, and anti-infectives. Guided by its purpose of \u201cCaring for Life,\u201d Cipla continues to deliver affordable, high-quality medicines to patients worldwide.<\/p>\n

Contacts<\/b> <\/p>\n

\nMedia Contacts:
\n
<\/b>Kemwell Biopharma Pvt Ltd
\n
Email: info.india@kemwellbiopharma.com<\/a>
Website: www.kemwellbiopharma.com<\/a><\/p>\n

\nCipla Limited
\n
Email: corpcomm@cipla.com<\/a>
Website: www.cipla.com<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Milestone expands India\u2019s role in global biologics manufacturing; collaboration with Cipla underscores commitment to quality and reliability BENGALURU, India–(BUSINESS WIRE)–Kemwell Biopharma Pvt Ltd (\u201cKemwell\u201d), 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 … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-62099","6":"format-standard","7":"category-industry"},"yoast_head":"\nKemwell Biopharma Facility in Bengaluru Successfully Completes U.S. FDA Inspection for Commercial Drug-Product Manufacturing - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/kemwell-biopharma-facility-in-bengaluru-successfully-completes-u-s-fda-inspection-for-commercial-drug-product-manufacturing\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Kemwell Biopharma Facility in Bengaluru Successfully Completes U.S. FDA Inspection for Commercial Drug-Product Manufacturing - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Milestone expands India\u2019s role in global biologics manufacturing; collaboration with Cipla underscores commitment to quality and reliability BENGALURU, India–(BUSINESS WIRE)–Kemwell Biopharma Pvt Ltd (\u201cKemwell\u201d), 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 ... 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