Granules' Sildenafil Oral Suspension FDA Approval for PAH

Granules India Limited announced that the US Food and Drug Administration (FDA) have approved an Abbreviated New Drug Application (ANDA) for sildenafil oral suspension submitted by its wholly owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI). 10 mg/ml. It is bioequivalent and therapeutically equivalent to Viatris Specialty LLC's Reference List Drug (RLD), Revatio for Oral Suspension, 10 mg/mL. Sildenafil for oral suspension is indicated for the treatment of pulmonary hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise capacity and slow clinical progression.

The granules now have a total of 63 ANDA approvals from the US FDA (61 final approvals and 2 preliminary approvals).

According to IQVIA/IMS Health, the current US sildenafil oral suspension market is estimated to be approximately $43 million in September 2023. Granules India Limited, established in 1991, is a vertically integrated, fast growing Indian pharmaceutical company headquartered in Hyderabad with best in class facilities and commitment to operational excellence, quality and customer service.

The company is one of the few pharmaceutical companies in the world that is involved in the entire production value chain - from active ingredients (API), pharmaceutical intermediates (PFI) and finished dosage forms (FD).