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Granules India gets USFDA approval for Sildenafil for Oral Suspension
04-Dec-23   10:41 Hrs IST

In a regulatory filing, the pharma major said, ?Granules India announced that the US Food & Drug Administration (US FDA) has approved its abbreviated new drug application (ANDA), filed by Granules Pharmaceuticals, Inc, a wholly owned foreign subsidiary of the company, for Sildenafil for Oral Suspension.?

Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension (world health organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.

The current annual U.S. market for Sildenafil for oral suspension is approximately $43 million, according to MAT September 2023, IQVIA/IMS Health.

Granules now have a total of 63 ANDA approvals from the US FDA (61 final approvals and 2 tentative approvals).

Granules India is primarily involved in the manufacturing and selling of Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation intermediates (PFIs) and Finished Dosages (FDs).

The company?s consolidated net profit declined 29.6% to Rs 102.12 crore despite of 3.4% rise in net sales to Rs 1,189.49 crore in Q2 FY24 over Q2 FY23.

Shares of Granules India added 0.13% to Rs 393.20 on the BSE.

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