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Shilpa Medicare gets 10 observations from US FDA for Jadcheria formulation facility

Our Bureau, Mumbai
Wednesday, December 6, 2017, 15:15 Hrs  [IST]

Shilpa Medcare, a Rs.775 crore plus pharma major from Raichur, has received major setback from US FDA 483 observations in respect of its SEZ formulation facilities situated at Jadcherla, Telangana. It received 7 observations regarding improvement in procedures and practices and 3 observations related to setting of analytical specifications, test procedures and method validation.

Shilpa Medcare scrip declined sharply by Rs.28.10 or 4.42 per cent in the afternoon session to Rs.607.05 on BSE. The scrip touched to its yearly high level at Rs.786 and lowest at Rs.537.10 on August 11, 2017.

In October 2017, the US FDA has issued an establishment inspection report (EIR) for its generic pharma manufacturing facility at Jadcherla, which was inspected between 24th and 28th July 2017. However, after submitting a detailed corrective and preventive action plan to the regulator within the stipulated timelines in response to the for 483 issued at the end of inspection, the US FDA has closed inspection in October.

The company's consolidated net sales for the first half ended September 2017 declined to Rs.373 crore from Rs.378 crore in the corresponding period of last year. However, its net profit improved to Rs.57.63 crore from Rs.51.47 crore. EPS worked out to Rs.7.18 as against Rs.6.88 in the last period.


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