The US Food and Drug Administration has issued an import alert on the generic Kamagra male erectile dysfunction tablet from Ajanta Pharma Ltd, which is manufactured at the company’s facility in Paithan, Maharashtra, according to the details in the website of the US regulator.
The US regulator issued import alert 66-41 on Kamagra. This import ban is issued when there is evidence for the marketing or promotion of drugs not approved in the United States.
Shares of Ajanta Pharma, which fell 14% in the news, recovered some losses later, and traded a 5.22% less at Rs1,690.55 at 2:00 PM in BSE, while the benchmark Sensex rose A 0.73% to 27315.58 points.
In a presentation to the stock exchanges, Ajanta Pharma said that there is no import alert on the company’s Paithan unit and that it continues to supply the US market. The company did not specify whether there was a ban on the importation of the drug in question. “We do not sell this product in the United States,” a company spokesman told Mint.
Kamagra tablets, which contain sildenafil citrate, were banned by the US drug regulator in 2009 as well.
According to a research analyst, the Ajanta Pharma drug does not have FDA approval from the US. And therefore, if you are entering the US, it would be through some unofficial channels. Therefore, there will be no financial impact on the company because of this action by the regulator, said the analyst, who does not want to be named citing the company’s policy.
Ajanta Pharma manufactures tablets, capsules and dry powder at the Paithan plant. In addition, it has five other factories.
Ajanta Pharma is expanding its business in the US market. As of September 2016, the company had received 15 product approvals, while 12 abbreviated new drug applications (ANDAs) were pending with the US FDA. for your 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 Was at Rs80 crore.