Biophore is manufacturing nirmatrelvir at a US FDA compliant facility and has announced that they will be filing for approval with DGCI soon. (Representational Image/ DC File)
Vishakhapatanam: Biophore India Pharmaceuticals has on Wednesday announced that they have developed and started manufacturing the key intermediates of nirmatrelvir, one of the active ingredients of Paxlovid, the latest anti-Covid therapy, approved by the US FDA through the emergency use authorisation route.
The manufacturing is in collaboration with Rakshit Group, which is expected to reduce the dependence on imports, mainly from China, from where these intermediates are obtained currently.
Biophore is also manufacturing nirmatrelvir at a US FDA compliant facility and has announced that they will be filing for approval with Drugs Controller General of India (DGCI) soon.
Speaking to Deccan Chronicle, Biophore CEO Jagadeesh Babu Rangisetty said, "We will get the drug approved within two to three months from the DCGI. The US and Canadian governments are already supplying the drug to the patients free of cost. It is a 90 per cent effective drug against Covid-19. We are manufacturing the tablet forms for the global market."
As and when the product gets approved in India, we can ensure that the manufacturers of this product can be self-reliant from within India, not depending on imports, which can be tricky in terms of control of quality and supply, Rangisetty said.
Paxlovid’s breakthrough approval was given by the US FDA in December 2021. It is indicated for the treatment of mild-to-moderate Covid-19 in adults and paediatric patients along with those who are at high risk of progressing to severe levels.
It was the first oral pill that has been approved by US FDA and with a better safety profile than subsequently approved oral therapies. It is available in a co-pack of nirmatrelvir and ritonavir tablets.