Granules India gains FDA approval for Sildenafil oral suspension ANDA


Granules India Limited has announced a major achievement with the US Food & Drug Administration (US FDA) approving its Abbreviated New Drug Application (ANDA). The approval was granted to Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of Granules India, for their product, Sildenafil for Oral Suspension, 10 mg/mL. This drug is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Revatio for Oral Suspension, 10mg/mL, originally of Viatris Specialty LLC.

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Sildenafil for Oral Suspension is specifically indicated for the treatment of pulmonary arterial hypertension (PAH) (World Health Organization [WHO] Group I) in adults. It aims to improve exercise ability and delay clinical worsening in patients. With this recent approval, Granules India now boasts a total of 63 ANDA approvals from the US FDA, which includes 61 final approvals and 2 tentative approvals.

FDA Nods Granules Pharmaceuticals' Generic Drug for Pulmonary Hypertension

FDA Nods Granules Pharmaceuticals’ Generic Drug for Pulmonary Hypertension

According to the latest market data from MAT Sep 2023 by IQVIA/IMS Health, the current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million. This approval signifies Granules India’s continued commitment to providing effective treatments for complex health conditions and marks a significant step in the pharmaceutical industry’s efforts to enhance patient care in pulmonary arterial hypertension.

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