US drug regulator issues import alert for Sun Pharma’s Gujarat unit

The US Food and Drug Administration (US FDA) has imposed a ban on imports from cephalosporin facility of Sun Pharmaceuticals Ltd, the country’s largest drug maker by market value, located at Karkhadi (Gujarat).

The shares of the company which opened at Rs 609.2 last changed hands at Rs 573 apiece, down 5 per cent from the previous day’s close on BSE in a weak Mumbai market on Thursday.

“This import alert was issued by the US FDA as a follow up to the last inspection of the facility, during which some non-compliance of current Good Manufacturing Practice (cGMP) regulations were identified,” Sun Pharmaceuticals announced in stock exchange in the afternoon on Thursday. 

It added that contribution of this facility to Sun Pharma’s consolidated revenues is negligible. Sun Pharma said it maintains its FY14 consolidated sales growth guidance.

According to company’s 2013 annual report, the plant at Karkhadi makes both drug ingredients and formulations.

This development comes at a time when Indian pharmaceutical companies are facing headwinds in their relationship with US FDA, which regulates the world’s largest pharmaceutical market.

Earlier US FDA commissioner Margaret Hamburg was visiting India to address concerns of Indian companies which faced clampdown by the regulatory body.

Drug major Ranbaxy has been the hardest hit and all its facilities in India have been banned from exporting products to the US market. Other pharma players which also faced similar action for their facilities include Wockhardt, Strides Arcolab and RPG Life Sciences.

(Edited by Joby Puthuparampil Johnson)

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