The company plans to commence commercial production of the product immediately after the approval is received, the Hyderabad-based firm said.
Drugmaker Biophore India Pharmaceuticals on Friday said it has applied to the Drugs Controller General of India (DCGI) seeking emergency use approval for Aviptadil Inhalation in the treatment of moderate to severe COVID-19.
The Hyderabad-based company said it has developed the product technology at its research and development (R&D) facility on the basis of the globally available product. It plans to commence commercial production immediately on receipt of the approval.
Aviptadil is a synthetic form of Vasoactive Intestinal Peptide which, 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 review,” a release from Biophore said.
CEO Jagadeesh Babu Rangisetty said the company has developed the highly complex peptide in a very short period of time, primarily due to its focus on prioritizing COVID related products over the last one year.
The company was one of the first few manufacturers in the country to receive approval for anti-viral agent, Favipiravir, during the first wave, and is the only Indian manufacturer to produce multi tonnage volumes of Sulfobutyl Ether beta Cyclodextrin (SBECD), a key excipient in the manufacturing of Remdesivir Injections.