Granules India receives USFDA approval for Dofetilide capsules

Granules India announced that the USFDA has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. for dofetilide capsules.

Dofetilide capsules are bioequivalent to the reference listed drug product of Tikosyn capsules of Pfizer Inc. The capsules are indicated for the maintenance of normal sinus rhythm (delay in time to recurrence of atrial fibrillation) in patients with atrial fibrillation/atrial flutter of greater than one week duration who have been converted to normal sinus rhythm. They are also indicated for the conversion of atrial fibrillation and atrial flutter to normal sinus rhythm.

The product would be manufactured at the GPI facility located in Chantilly, Virginia, USA and is expected to be launched shortly. Granules now has a total of 45 ANDA approvals from US FDA (43 Final approvals and 2 tentative approvals).

According to IQVIA Health, dofetilide capsule products had U.S. sales of approximately $39 million for the most recent twelve months ending in August 2021.

Shares of Granules India were trading 1.05% lower at Rs 325 on BSE.

Granules India is a vertically integrated fast growing Indian pharmaceutical company headquartered at Hyderabad. The drug company posted a 7.9% rise in consolidated net profit to Rs 120.2 crore on a 15.5% increase in net sales to Rs 849 crore in Q1 FY22 over Q1 FY21.

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