Shilpa Medicare shares hit lower circuit after USFDA observations for Telangana unit

The US Food and Drug Administration (USFDA) issued form 483 with 15 observations to the company’s Jadcherla Unit

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At the conclusion of the inspection, the agency issued Form 483, with 15 observations.
Shares of Shilpa Medicare hit the lower circuit of 5 per cent on Wednesday after the US Food and Drug Administration (USFDA) issued form 483 with 15 observations to the company’s Jadcherla Unit.

The scrip declined 5 per cent to Rs 489, while the benchmark BSE Sensex was down 0.48 per cent at 40,089 in the afternoon trade.

In a regulatory filing, the company said that the US FDA conducted Good Manufacturing Practices (GMP) inspection of Shilpa Medicare Ltd's Finished Dosage Formulation Facility (Sterile and Non-sterile) located at Jadcherla, Telangana State from Feb 13-15, 2020. At the conclusion of the inspection, the agency issued Form 483, with 15 observations.


“The company is preparing responses to the observations, which will be submitted to the agency within 15 business days. The company is committed to address these observations promptly,” Shilpa Medicare said.
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