Hyderabad-based Biophore India Pharmaceuticals on Friday announced it has applied for DCGI emergency use approval of Aviptadil Inhalation for marketing in India for the treatment of moderate to severe cases of COVID-19.
Biophore has successfully developed Aviptadil and is backward integrated with in-house API, the pharma company, which develops and manufactures niche pharmaceutical products for the generic industry. Once approved for the Aviptadil, it will commence commercial production immediately.
Aviptadil is a synthetic form of Vasoactive Intestinal Peptide (VIP) that, when administered, results in rapid clinical recovery in patients with severe SARS-COV-2 infection. These observations are based on results of multiple trials of Aviptadil against COVID-19 globally in patients with respiratory failure and the same have been submitted to DCGI for their review.
Biophore CEO Dr Jagadeesh Babu Rangisetty, said Aviptadil is a very promising treatment option for COVID, especially in severe hospitalized cases where trials have shown a high recovery percentage and we hope to be able to quickly make it available through this approval.
It has been actively involved in developing products against COVID-19 and scaling up manufacturing to meet the requirements.
The company was one of the first few manufacturers to have received approval for an anti-viral agent, Favipiravir, in India during the first wave and is also the only Indian manufacturer to be producing multi tonnage volumes of Sulfobutyl Ether beta Cyclodextrin (SBECD), which is a key excipient in the manufacturing of Remdesivir Injections.
Apart from these, Biophore has invested significantly into the research and development of other anti-COVID products over the last one year.
Biophore’s state-of-the-art, multipurpose manufacturing facilities in Visakhapatnam and Hyderabad comply with cGMP standards and meet the requirements of US and EU Drug regulatory authorities.