Hyderabad: Hyderabad-based Biophore India Pharmaceuticals has appeal to Drugs Controller General of India emergency for approval of Aviptadil inhalation for marketing in India for the treatment of moderate to severe cases of Covid-19.
Biophore has produced Aviptadil and is backward integrated with in-house bulk drugs. The company told that it will start commercial production immediately after the approval is received.
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.
The observation is 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.
Dr Jagadeesh Babu Rangisetty, CEO at Biophore, said, “Biophore has developed this highly complex peptide in a very short period of time, primarily due to the extensive focus of the company in prioritising Covid related products over the last one year.”
Biophore has been actively involved in developing products against Covid-19 and scaling up manufacturing to meet the requirements.
The company earlier received approval for an antiviral 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.
Dr Jagadeesh Babu adds, “While we are optimistic that the pandemic will end soon, we have to be prepared for the exigencies. We need 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. Our aim is also to make the cost of treatment affordable, especially for hospitalised patients.”
