Post 14% fall, Ajanta Pharma denies alert from USFDA, says supply is on

FPJ Web DeskUpdated: Thursday, May 30, 2019, 09:43 AM IST
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Shares of Ajanta Pharma fell to 14.36 per cent in early trade on Tuesday after media reports said that company has got import alert from the USFDA. Drug firm Ajanta Pharma today said that there is no import alert by the USFDA on the company’s manufacturing unit in Aurangabad and it continues to supply to the US market. USFDA notified the import alert on its website on January 20.

According to money control.com 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.

However, the company has denied that it has received any import alert by USFDA and issued a statement about the same. “We want to clarify that there is no import alert on us by USFDA and we continue to supply to US market,” Ajanta Pharma said in a BSE filing. There has been media reports saying the company has got import alert from US FDA for its Paithan unit at Aurangabad.

Shares of Ajanta Pharma were trading 4.16 per cent lower at Rs 1,709.50 on BSE. Later in the day the company will announce its financial results for the quarter ended December 31, 2016. For the quarter ended September 31, 2016, the company posted a consolidated net profit of Rs 130.66 crore, up 26.31 per cent, against Rs 103.44 crore in the corresponding quarter last year.

According to Financial Express 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.

Ajanta Pharma is a specialty pharmaceutical company engaged in development, manufacture and marketing of quality finished dosages in domestic and international markets. It was established in 1973 and headquartered in Mumbai-India. Ajanta Pharma makes Tablets and Capsules at Paithan in Aurangabad. The facility is spread across 28,100-square meter; it was set up in 1983.

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