US FDA issues import ban on Ajanta Pharma’s Kamagra tablets

Mumbai: The US Food and Drug Administration has issued an import alert on Ajanta Pharma Ltd’s generic male erectile dysfunction tablet Kamagra, which is manufactured at the company’s facility at Paithan in Maharashtra, according to details on the US drug regulator’s website.

The US regulator has issued import alert 66-41 on Kamagra. This import ban is issued when evidence exists for the marketing or promotion of unapproved drugs into the US.

Shares of Ajanta Pharma which plunged 14% on the news recouped some losses later, and were trading 5.22% lower at Rs1,690.55 at 2.00 PM on the BSE, while the benchmark Sensex was up 0.73% at 27315.58 points.

In a filing to stock exchanges, Ajanta Pharma said there is no import alert on the company’s Paithan unit and that it continues to supply to the US market. The company did not specify if there is an import ban on the drug in question. “We do not sell this product in the US,” a company spokesperson told Mint.

Kamagra tablets, which contain sildenafil citrate, were banned by the US drug regulator in 2009 as well.

According to a research analyst, Ajanta Pharma’s drug does not have US FDA approval and so, if it is entering the US, it would be through some unofficial channels. Hence, there will not be any financial impact on the company because of this action by the regulator, said the analyst, who did not wish to be named citing company policy.

Ajanta Pharma manufactures tablets, capsules and dry powder at the Paithan facility. Besides, it has five other manufacturing plants.

Ajanta Pharma is scaling up its business in the US market. As of September-end, 2016, the company had received 15 product approvals, while 12 abbreviated new drug applications (ANDAs) were pending with the US FDA for approval. It plans to file 8-12 ANDAs with the US FDA every year.

In the quarter ended September 2016, the company’s sales in the US stood at Rs80 crore.