Ajanta Pharma gets import ban for selling unapproved drug in US

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26 Aug, 2025 12:21

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Moneycontrol BureauShares of Ajanta Pharma fell as much as 12.35 percent and was trading at Rs 1563.40 at 9.50 am on Tuesday after the company got an import alert from USFDA for selling an unapproved drug in the US from its Aurangabad facility.USFDA notified the import alert on its website on January 20.The import alert falls in the category of 66-41 which relates to marketing or promotion of unapproved products.

In this case, Ajanta was found marketing its erectile dysfunction drug Kamarga in United States without proper approvals.Kamarga uses an active ingredient Sildenafil Citrate (a.k.a Viagra).The import alert makes it difficult for this particular product to enter US shores as only FDA-approved products are accorded physical checks.Ajanta Pharma clarified that there was no import alert by US FDA on its facility or any of its ur products approved by US FDA. "It appears that some unknown and unrelated entity/individual has sent some Sildenafil manufactured by Ajanta Pharma being sold in India or other emerging market to USA. We have no relations or connection to this dispatch of Sildenafil to USA. US authorities have seized this product as it is not approved by US FDA. We once again clarify that there is no import alert on our facility or any of our products approved by US FDA and we continue to supply the products to US," the statement said.

 “What we understand from the import alert is that it is not due to any deviations from manufacturing practices at the facility,” said an analyst tracking pharma on condition of anonymity.“Even then, selling an unauthorized product is a serious offense,” the analyst said.The analyst said the company now needs to convince the USFDA that product was shipped without its authorization.Kamarga and drugs based on Viagra used for treatment of erectile dysfunction are also popular as recreational drugs in the US. These drugs are often shipped illegally and sold online without valid prescriptions.