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“The company has received 483 Observations from the United States Food & Drug Administration (USFDA) in relation to SEZ Formulation Facilities situated at Jadcherla, Telangana (near Hyderabad),” Shilpa Medicare said in a statement.
Total 10 observations were cited during the close up meeting. Of these 7 observations are improvement in procedures and practices, while 3 observations are related to setting of analytical specifications, test procedures and method validation, it added.
At 01:37 PM; the stock was trading 4% lower at Rs 609 as compared to 0.44% decline in the S&P BSE Sensex. A combined 191,781 shares changed hands on the counter on the NSE and BSE so far.