Express Pharma

Sun Pharma receives 11 observations from US FDA for Dadra plant


The news has caused Sun Pharma’s stock to fall as much as three per cent

Sun Pharma’s Dadra unit received 11 observations after US FDA inspection. The regulator highlighted incomplete lab records, failure to create accurate duplicates of key records, and to adequately investigate drug batches that didn’t meet specifications as violations during the inspection. The news has caused Sun Pharma’s stock to fall as much as three per cent. The company has come under scrutiny from US regulators in the past as well. The company’s plat in Halol, Gujarat is also under an FDA warning letter that prevents the launch of new product from that facility to the US.

Commenting on the US FDA issual of 483 to the company, Sarabjit Kour Nangra, VP Research- Pharma, Angel Broking said, “Dadra site is the biggest unit for the company after Halol plant, for supplying drug in the United States. In FY2016, Halol contributed ~7-9 per cent of total sales and >15 per cent of US sales for the company. While currently these are only observations and will not lead to any negative impact on the earnings of the company. Though if not rectified could let to significant impact on US numbers. Apart from these two facilities, the company has only one facility in Gujarat in India, which is for API and formulation both.”

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