USFDA issues 7 observations to Baddi unit of Glenmark Pharmaceuticals (Representational image)
Glenmark Pharmaceuticals said on Tuesday that the US Food and Drug Administration (FDA) had made seven observations after an audit at its manufacturing unit in Baddi. Glenmark Pharma shares fell as much as 3 per cent to an intraday low of Rs 573.95. Glenmark Pharmaceuticals' Baddi unit underwent an audit by the US health regulator from November 6 to November 11, 2017. After the audit, the US Food and Drug Administration issued seven observations through the form 483, informed the pharmaceuticals company.
"We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA shortly on the observations," said Glenmark Pharmaceuticals in a regulator filing.
The Baddi unit contributes approximately 10 per cent of the revenue of US sales, the filing noted.
At 11:20 am, Glenmark Pharma shares were trading 2.33 per cent lower at Rs 577 on the BSE. The stock traded close to its 52-week low of Rs 565 on the exchange.
Glenmark Pharma reported a net profit after tax (PAT) of Rs 327.88 crore in Q2, as against Rs 555.8 crore in the corresponding period a year ago.