Dispelling a notion that one of its products has received an import alert from the US Food and Drug Administration (USFDA), Ajanta Pharma, the Mumbai-based generic drug maker, clarified that the product in question was never supplied to the US market by them.
According to the USFDA website, one of Ajanta’s products manufactured at its Paithan facility in Aurangabad, Maharashtra received import alert number 66-41, which pertains to detention without physical examination of unapproved new drugs promoted in the US, which may present potentially serious safety and effectiveness concerns. The drug in question was Kamagra, which contains Sildenafil Citrate, and is used to treat male erectile dysfunction.
“We intend to clarify that there is no import alert by USFDA on our facility or any of our products approved by the USFDA,” Ajanta Pharma said in a statement issued on Tuesday. “It appears that some unknown and unrelated entity/individual has sent some Sildenafil manufactured by Ajanta Pharma sold in India or other emerging markets to USA. We have no relation or connection to this dispatch.”
The company further clarified that it continues to supply its products to the US market.
News of the import alert, which was published by the USFDA on January 20, led Ajanta’s share prices to tank on the bourses on Tuesday. However, the scrip recovered from the day’s low to close at Rs1754 per share, down 1.66 percent, The bourse’s benchmark index, S&P BSE Sensex gained 0.92 percent.