1. Ajanta Pharma shares recover as company says FDA import alert drug not sold in US

Ajanta Pharma shares recover as company says FDA import alert drug not sold in US

The Indian drugmaker’s management sought to calm the concerns, saying that the drug is not sold in the US, implying that the alert may not hurt it much. Shares were now trading down 4.41% at Rs 1,707.85 on NSE.

By: | Updated: January 24, 2017 11:38 AM
Ajanta Pharma’s management sought to calm the concerns, saying that the drug is not sold in the US. Ajanta Pharma’s management sought to calm the concerns, saying that the drug is not sold in the US.

Ajanta Pharma shares recovered losses after clarity and management comments on the news of US FDA “import alert” on its Kamagra drug. The Indian drugmaker’s management sought to calm the concerns, saying that the drug is not sold in the US, implying that the alert may not hurt it much.

Shares were now trading down 4.41% at Rs 1,707.85 on NSE.

Earlier, Ajanta Pharma shares plummeted as much as over 12% on news of the drugmaker getting an “import alert” from the United States Food and Drug Administration for its male potency drug Kamagra, manufactured in Aurangabad in Maharashtra.

Ajanta Pharma sells Kamagra drug only in the emerging markets, ET Now said citing the company without identifying the spokesperson. It added that the import alert is only on the Kamagra drug, and not on the whole facility. The last US FDA inspection of the Aurangabad facility took place in 2015, it said.

US FDA said in the notes that the product contains Sildenafil Citrate.

US FDA issues import alerts on drugs and other products if it suspects those to be in violation of rules. “Import alerts inform FDA field staff and the public that the agency has enough evidence to allow for Detention Without Physical Examination (DWPE) of products that appear to be in violation of FDA laws and regulations. These violations could be related to the product, manufacturer, shipper and/or other information,” the US FDA says on its website.

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Ajanta Pharma makes Tablets, Capsules and Dry Powder at its Paithan facility. The 28,100-square meter facility was set up in 1983.

Earlier, Ajanta Pharma had received final approval for duloxetine hydrochloride delayed release capsule from the US FDA. The capsule is a generic version of Eli Lilly’s Cymbalta.

Ajanta has 32 abbreviated new drug applications (ANDAs), out of which it has 17 final ANDA approvals, 2 tentative approvals and 13 ANDAs under review with US FDA.

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