Ranbaxy's Mohali Plant Under U.S. FDA Lens


Bangalore: In yet another setback to, The U.S. Food and Drug Administration (FDA) has issued an import alert on drugs produced by Ranbaxy Laboratories at its Mohali plant in Punjab, for violation of current good manufacturing practices.

According to information available on the U.S. FDA website, the import alert, will cover all ‘drugs and drug products’ produced by the company at the Mohali plant.

While the U.S. health regulator did not specify details for issuing the alert, it said “detention without physical examination may be appropriate when an FDA inspection has revealed that a firm is not operating in conformity with current good manufacturing practices”.

When contacted, a Ranbaxy spokesperson said: “We have so far not received any communication from the U.S. FDA on this subject. We are seeking information from the U.S. FDA in this regard.”

As per the company’s website, the Mohali plant produces oral solids in dosage form.

This year, Ranbaxy had pleaded guilty to “felony charges” relating to manufacture and distribution of certain ’adulterated’ drugs made at two units in India and agreed to pay $500 million to U.S. authorities as penalty.

Ranbaxy Laboratories shares were trading at 332.85 per scrip, in the afternoon trade, down 27.21 per cent from its previous close on BSE.

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Source: PTI