Granules India's Sildenafil for Pulmonary Arterial Hypertension Gets FDA Approval

Sildenafil for oral suspension plays a crucial role in treating pulmonary arterial hypertension (PAH) in adults, aiming to enhance exercise capability and defer clinical deterioration, as per the World Health Organization (WHO) Group I classification.

Hyderabad-based Granules India Limited, a leading Indian pharmaceutical company, has received approval from the US Food & Drug Administration (US FDA) for its Sildenafil for oral suspension, 10 mg/mL. 

The drug is indicated for treating pulmonary arterial hypertension (PAH) in adults, specifically WHO Group I, to enhance exercise capacity and delay clinical deterioration.

Granules Pharmaceuticals, Inc (GPI), a wholly owned foreign subsidiary of Granules India Limited, filed the abbreviated new drug application (ANDA) for Sildenafil, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Revatio for oral suspension, 10 mg/ml, by Viatris Specialty LLC.

Sildenafil for oral suspension plays a crucial role in treating pulmonary arterial hypertension (PAH) in adults, aiming to enhance exercise capability and defer clinical deterioration, as per the World Health Organization [WHO] Group I classification.

The current market data reveals that the annual US market for this medication stands at around $43 million, based on MAT Sep 2023, IQVIA/IMS Health.

Granules India Limited, established in 1991 and headquartered in Hyderabad, stands out as a vertically integrated pharmaceutical company with a comprehensive approach, covering active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediates (PFIs), and finished dosages (FDs).

In a related development, Zydus Lifesciences has secured final approval from the USFDA for its generic Ivabradine tablets, which are used in treating heart failure. The approved tablets, with strengths of 5 mg and 7.5 mg, will be manufactured at the company's formulation manufacturing facility in Ahmedabad SEZ, India.

Simultaneously, Dr. Reddy's Laboratories introduced Nerivio, a US FDA-approved wearable therapy device designed for drug-free migraine management in India. 

This prescription-based, non-invasive device is suitable for both acute and preventive treatment of migraines in adults and adolescents aged 12 years and above. Worn on the upper arm, Nerivio provides 18 sessions of 45 minutes each.