Hyderabad, Jan 19 (IANS) Biophore India Pharmaceuticals on Wednesday announced that it developed and started manufacturing the key intermediates of Nirmatrelvir, one of the active ingredients of Paxlovid, the latest anti-Covid therapy, approved by US authorities.
The anti-viral pill developed by Pfizer recently received emergency use authorisation by the US Food and Drug Administration (USFDA).
Hyderabad-based Biophore said the manufacturing of key intermediaries of Nirmatrelvir is being done in collaboration with Rakshit Group. This is expected to greatly reduce the dependence on imports, mainly from China, from where these intermediates are being procured currently.
Biophore is also manufacturing Nirmatrelvir in a FDA compliant facility and has announced that it will be filing for approval with Drugs Controller General of India (DCGI) soon.
Paxlovid’s breakthrough approval was given by the FDA in December 2021 and is indicated for the treatment of mild-to-moderate Covid-19 in adults and paediatric patients as well and in those who are at high risk of progression to severe levels. It was the first oral pill that has been approved by FDA and with a better safety profile than subsequently approved oral therapies. It is available in a co-pack of Nirmatrelvir and Ritonavir tablets.
“The development and manufacturing of these intermediates is extremely complex and is significantly more challenging than earlier antivirals that have been indicated for Covid. We have developed the intermediates that are required for the manufacturing of this product from basic raw materials and have the manufacturing capabilities in place to produce high volumes, to the scale of multi tons, catering to Indian as well as global markets,” said Dr Jagadeesh Babu Rangisetty, CEO, Biophore.
“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 itself and not be dependent on imports, which can be tricky in terms of control of quality and supply,” he added.
Rameswara Rao Chandana, Chairman of Rakshit Group, said their Sainor Laboratories, is the largest manufacturer of Lithium HMDS in India with a capacity of 500 tonnes per month and has the facilities to handle cryogenic reactions.
“Manufacturing of these intermediates require extreme temperatures and large volumes of Lithium reagents and with the above infrastructure that we have, we are well placed to ensure that the requirements for the market can be met locally. With a strong partner such as Biophore, we believe this is a perfect synergy to get these products to the market quickly,” he said.