BREAKING: the FDA just banned all imports from Sun Pharmaceuticals, makers of Modalert (modafinil) and Waklert (R-modafinil)
UPDATE 2016: It appears that Modalert imports from Sun Pharma have been partially or fully instated. Thanks to Corpina reader Gautam for notifying me of the fix:
Here’s a round-up of the stories thus far:
The U.S. Food and Drug Administration (FDA) has banned imports from Indian generic drugmaker Sun Pharmaceutical Industries Ltd’s plant at Karkhadi in the western state of Gujarat, in the latest quality blow for India’s drug sector.
The FDA has imposed a rash of regulatory sanctions on Indian generic makers in the last year, triggering concerns about the quality of the medicines supplied by the $14 billion industry to countries including the United States, the biggest market.
US regulators slapped an import ban on some products of top Indian drugmaker Sun Pharma, sending the firm’s shares tumbling Thursday and dealing a fresh blow to the nation’s beleaguered generics industry.
The US Food and Drug Administration (FDA) announced an “import alert” late Wednesday on drugs made by Sun at one of its plants in western India over failure to meet “good manufacturing practices”.
The FDA action against India’s largest drugmaker by market capitalisation comes as US regulators scale up scrutiny of India’s $14-billion-a-year pharmaceutical sector to eliminate quality lapses and worries about safety.
Sun’s shares fell as much as 6.4 percent before recovering slightly to close down 3.28 percent at 551.70 rupees.
Shares of Sun Pharmaceutical Industries Ltd dropped as much as 6.36% on BSE on Thursday after the US drug regulator issued an import alert against its Karkhadi plant in Gujarat, banning shipments from the factory that makes some pharma ingredients and formulations for the US market.
“This factory near Vadodara in Gujarat that makes a small quantity of antibiotics got an import alert on Thursday,” said a person at Sun Pharmafamiliar with the development. “But the revenue impact is very negligible.”
After falling to as low as Rs.565.60 on BSE in intra-trading, the shares closed 5.03% lower at Rs.573.60 on a day the exchange’s benchmark Sensex fell 0.37% to 21.774.61 points.
The contribution of the Karkhadi facility, near Vadodara, to Sun Pharma’s consolidated revenue is negligible, and the drug maker maintains its 2013-14 fiscal’s consolidated sales growth forecast, a Sun Pharma spokesman said in a statement.
Since January 2013, the FDA has added more than 20 Indian drug facilities to its import aler