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19 Mar 2018

DRL’s API plant in Medak and Biocon’s Malaysian Plant got USFDA 483 observations

  • Dr Reddy’s Laboratories received the US Food and Drug Administration has issued a Form 483 with four observations after inspecting its active pharmaceutical ingredients facility in Medak, Telangana. Last week also, the company said that the USFDA had issued Form 483 with five observations.
  • Biocon’s Malaysian Plant Gets Six Observations From U.S. Drug Regulator. The Malaysian unit, run under the Mylan-Biocon partnership, is largely focused on insulin variants and had filed an approval for making glargine. It is a pre-approval inspection because they do not manufacture anything in that unit as of now. 

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