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    Power Failures Land India-Based Cancer API Manufacturer a Form 483

    Following a five-day inspection last month, the US Food and Drug Administration (FDA) sent a Form 483 to active pharmaceutical ingredient (API) manufacturer Shilpa Medicare Limited after the agency uncovered long-lasting power failures at the site. “During the walkthrough on 24 July 2019, three power failures occurred within the facility during a 15-minute interval and a back-up generator did not resume power,” FDA investigator Yvins Dezan wrote. And while reviewing aud...
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    Asia Regulatory Roundup: India to Add EU to List of Regions Covered by Clinical Trial Waiver

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   India Seeks Feedback on Mandatory use of QR Codes on API Packaging   India is planning to require manufacturers to feature quick response (QR) codes on the packaging of locally made and imported active pharmaceutical ingredients (API). The Indian government plans to implement the system at the start of April.   Through an amendment to the Drugs and Cosmetics Rule...
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    FDA Warns Fresenius Kabi API Manufacturing Plant

    The US Food and Drug Administration (FDA) last week released a warning letter sent to Fresenius Kabi's active pharmaceutical ingredient (API) manufacturing plant for liquid pharmaceutical products in Kalyani, India, for deficiencies that the company says will not impact product supplies. The warning letter, sent 18 December and following an eight-day inspection in April 2017, raises questions about Fresenius' failure to adequately address a sterility failure. FDA sa...
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    FDA Warns Chinese Firm for Confusing API in OTC Drug

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last Monday to China-based Guangdong Zhanjiang Jimin Pharmaceutical Co. after finding that one of the over-the-counter drugs the firm made was labeled as containing the active pharmaceutical ingredient (API) hydrocortisone, but really the drug contained dexamethasone acetate. The company told FDA that the mix-up is the result of "a translation mistake," according to the warning letter...
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    Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Opens Door to Foreign Clinical Trial Data to Accelerate Drug Approvals China is planning to accept data generated from clinical trials run overseas. The proposal is part of a suite of changes put forward by the State Council to boost China’s support for innovative drugs and devices and accelerate their path to patients. The State Council broke its proposals up i...
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    FDA Warns Chinese API Manufacturer for a Lack of Written and Quality-Related Procedures

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to China-based active pharmaceutical ingredient (API) manufacturer Changzhou Jintan Qianyao Pharmaceutical Raw Material Factory for, among other issues, failing to have written procedures on its handling of raw materials. FDA noted, "When our investigator asked for a list of your critical raw materials and your sampling requirements, you told our investigator that you had no writte...
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    WHO Seeks Additional Birth Control API Manufacturers as US FDA Bans China Site

    A Chinese manufacturer of the active pharmaceutical ingredient (API) for the birth control drug levonorgestrel has been placed on the US Food and Drug Administration’s (FDA) import alert list, causing the World Health Organization (WHO) to scramble to find a replacement. "At the moment, there is no alternative levonorgestrel API which has been prequalified," WHO said Wednesday. When an API is prequalified by WHO, it can be used for the manufacture of finished pharmaceuti...
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    A Peek Behind the Curtain: 706 FDA Form 483 Requests in 2016 for Indian and Chinese Manufacturers

    As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these manufacturing sites and in 2016 that involved issuing hundreds of Form 483s and responding to more than 700 requests for the inspection reports. Thanks to the Freedom of Information Act, Focus obtained from FDA two lists detailing not only the 86 requests for the Form 483s issue...
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    New FDA Warning Letters Highlight CGMP Deviations at API Plants in China, India

    The US Food and Drug Administration (FDA) on Tuesday released two new warning letters for active pharmaceutical ingredient manufacturers Badrivishal Chemicals & Pharmaceuticals and Lumis Global Pharmaceuticals, both sent 2 March. The letter for Talegaon Dabhade, India-based Badrivishal follows a three-day inspection from last August in which FDA uncovered that the site’s water purification system was not adequately monitored and controlled. FDA investigators also found...
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    Japan Joins International API Manufacturing Inspection Program

    Japan’s Pharmaceutical and Medical Devices Agency (PMDA) announced Thursday that it will join with the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and other regulators to improve the efficiency and effectiveness of good manufacturing practice (GMP) inspections for sites producing active pharmaceutical ingredients (APIs). “PMDA has decided to join this program from 24 November 2016,” the agency said in an announcement. “The participation in...
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    FDA Warns Chinese Heparin Manufacturer, Reigniting Questions of Contamination

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to a China-based manufacturer of heparin—the same manufacturer warned by French regulators last March. The letter says the company used crude heparin batches that potentially were out of specification (OOS) to manufacture heparin sodium for the US market and shows that previous issues related to heparin sourced from Chinese active pharmaceutical ingredient (API) manufac...
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    FDA Finalizes Contract Manufacturer Quality Arrangement Guidance From 2013

    The US Food and Drug Administration (FDA) on Tuesday finalized guidance on contract manufacturer quality agreements. FDA said the differences between the draft from May 2013 and the final guidance focus on areas that needed to be clarified. “In particular, our revisions clarified the scope and applicability of the guidance and key terms used in the guidance. Regarding scope and applicability, we have clarified that the guidance is limited to commercial manufacturing...