1. Ajanta Pharma stocks tumble as US FDA issues import alert on its Kamagra drug

Ajanta Pharma stocks tumble as US FDA issues import alert on its Kamagra drug

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 Kamagra drug manufactured in Aurangabad in Maharashtra.

By: | Updated: January 24, 2017 10:55 AM
Ajanta Pharma makes Tablets, Capsules and Dry Powder at its Paithan facility. The 28,100-square meter facility was set up in 1983. (Representative Image: Reuters) Ajanta Pharma makes Tablets, Capsules and Dry Powder at its Paithan facility. The 28,100-square meter facility was set up in 1983. (Representative Image: Reuters)

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 Kamagra drug manufactured in Aurangabad in Maharashtra.

At the time of writing this copy, shares were trading at Rs 1,582.75, down 11.41% from its previous close.

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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The import alert pertains to the male potency drug, Kamagra, manufactured at Paithan facility of Ajanta Pharma. US FDA said in the notes that the product contains Sildenafil Citrate.

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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