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Indian Pharma Companies vs US FDA

  • Ranbaxy, US FDA, pharma

    USFDA, this week, issued an import alert on the company’s Mohali unit after finding suspected hair in its tablet. The company has had run-ins with the regulator since 2006 about violations of the US Current Good Manufacturing Practices. A big blow came in May 2013 when Ranbaxy was fined $500 mn after pleading guilty on 7 counts of fraud.

  • Strides Arcolab, US FDA, pharma

    Strides Arcolab’s injectable manufacturing arm Aglia Specialities received a warning letter this week from the USFDA for violation of manufacturing norms at its Sterile making facility in Bangalore. Agila Specialities has received warning letters with observations earlier as well.

  • Wockhardt, US FDA, pharma

    Drug maker Wockhardt, whose Waluj facility in Maharashtra came under an international regulatory scanner limiting its import revenue, had the USFDA inspecting two other units of the company last month – Chikalthana and a Cephalosporin facility.

  • Fresenius Kabi Oncology, Pharma, US FDA

    The US health regulator issued a warning letter to Fresenius Kabi Oncology for violation of manufacturing norms at its Kalyani facility in West Bengal in July this year warning the API manufacturer of withholding new applications unless corrective steps were taken.

  • RPG Life Sciences

    USFDA issued a warning letter to RPG Life Sciences for violation of Current Good Manufacturing Practice norms at its two plants at Ankleshwar, Gujarat and Navi Mumbai, Maharashtra in June this year. "These violations cause your APIs and drug products to be adulterated," USFDA said on its website.

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