Hyderabad: Hyderabad-based Biophore India Pharmaceuticals on Friday announced that it has applied for Drugs Controller General of India (DCGI) emergency use approval of Aviptadil Inhalation for marketing in India, IANS reported.
Successfully developed by Biophore, Aviptadil is recommended for the treatment of moderate to severe cases of Covid-19 cases.
The company will be commencing commercial production immediately following the approval by DCGI.
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.
"Biophore has developed this highly complex peptide in a very short period of time, primarily due to the extensive focus of the company in prioritizing Covid related products over the last one year.
These observations are based on results of multiple trials of Aviptadil against Covid-19 globally in patients with respiratory failure and the same has been submitted to DCGI for their review, it said.
Biophore CEO Jagadeesh Babu Rangisetty hailed Aviptadil as a very promising treatment option for Covid, especially in severe hospitalized cases where trials have shown a high recovery percentage and expressed hope in quick approval for the drug.
Biophore 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 year.
The CEO also advised preparing for the exigencies. He also urged to keep evaluating and adding newer products against this virus to ensure better preparedness by having more options for the treating physicians and thus avoiding shortages.
He further added that the company's aim was to make the cost of treatment affordable, especially for hospitalized patients.