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| Exchange Received Time 29/03/2017 21:30:42 Exchange Disseminated Time 29/03/2017 21:30:47 Time Taken 00:00:05 | | In furtherance to the intimation captioned 'Update on US FDA Inspection at Alkem's Ankaleshwar API Facility' dated 12th December, 2016, this is to inform you that the US FDA has issued an Establishment Inspection Report (EIR) for the Company's Active Pharmaceutical Ingredient (API) manufacturing facility located at Ankaleshwar, India which was inspected in December 2016. The inspection has now been closed by the US FDA. In response to the Form 483 issued by the US FDA, the Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines. The US FDA has reviewed the CAPA and has found them acceptable. A copy of Press Release is enclosed herewith for your information. Kindly take the same on record. |
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