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  • Regulatory NewsRegulatory News

    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...
  • RoundupsRoundups

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    FDA Warns Chinese Drug Manufacturer for Limiting Inspection, Systemic Data Manipulation

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Beijing Taiyang Pharmaceutical Industry Co. on 19 October after the company limited FDA’s ability to conduct an inspection and manipulated manufacturing data. The warning letter follows FDA adding the company to two import alert lists in April, effectively halting its ability to ship products to the US. Barred Entry to Warehouse On 16 November 2015, FDA investigators observed throu...
  • Regulatory NewsRegulatory News

    WHO Seeks API Manufacturers for Prequalification Program

    The World Health Organization (WHO) has released an invitation to active pharmaceutical ingredient (API) manufacturers as part of an effort to increase access to and the affordability of care and treatment of HIV/AIDS, hepatitis B and C, tuberculosis, malaria, neglected tropical diseases, influenza, diarrhea and support reproductive health. WHO invites manufacturers of selected APIs to submit Expressions of Interest (EOIs) for API evaluation and says the ultimate aim of...
  • Regulatory NewsRegulatory News

    French Regulators Raise Serious Concerns With Indian API Manufacturer

    France’s National Agency for Medicines and Health Products Safety (ANSM) on Monday released a new statement of serious good manufacturing practice (GMP) non-compliance for India-based active pharmaceutical ingredient (API) manufacturer Nandu Chemicals Industries. In an inspection from 20 August, the French regulators uncovered significant deficiencies linked to “the vast majority of inspected areas” at Nandu’s Hubli, India site. In particular, the inspectors highli...