Granules India’s arm gets USFDA’s approval for Sildenafil for Oral Suspension

04 Dec 2023 Evaluate

Granules India’s wholly owned foreign subsidiary - Granules Pharmaceuticals, Inc (GPI) has received US Food & Drug Administration (USFDA) approval for its Abbreviated New Drug Application (ANDA) for Sildenafil for Oral Suspension, 10 mg/mL. It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Revatio for Oral Suspension, 10mg/ml, of Viatris Specialty LLC. 

Sildenafil for Oral Suspension is indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults to improve exercise ability and delay clinical worsening.

Granules now has a total of 63 ANDA approvals from the US FDA (61 final approvals and 2 tentative approvals). The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million, according to MAT September 2023, IQVIA/IMS Health. 

Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).

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