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Dr Reddy's Labs manufacturing facility at Duvvada near Visakhapatnam, Andhra Pradesh has received 13 observations from the US health regulator. The facility handles oncology formulations, cytotoxic and hormonal injectables.
The Hyderabad-based pharma major informed BSE that the audit of its formulation manufacturing facility at Duvvada was completed by the USFDA on Thursday. The company has been issued a form 483 with 13 observations, which it said was addressing.
Following this, the company shares in the BSE fell by over 5 per cent to Rs 2,708.60, down 142.80, to its 52 week low.
The company had earlier on February 21, 2017 had informed about inspection of USFDA of another facility at Miryalaguda in Telangana, wherein it was issued a Form 483 with three observations, which the company was seeking to address. On both these occasions, the company did not specify the observations made by the USFDA inspection.
The USFDA issues form 483 with specific observations which the company is expected to respond and initiate corrective measures. For the pharma company, US accounts for a major chunk of its business and early compliance would help it address the market.
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