Reduces dependence on China for Indian manufacturers
Paxlovid approved by US FDA for COVID treatment
Biophore India Pharmaceuticals has today 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 US FDA through the emergency use authorisation route. The manufacturing 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 US FDA compliant facility and have announced that they will be filing for approval with DCGI soon.Paxlovid’s breakthrough approval was given by the US FDA in Dec 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 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.
Dr. Jagadeesh Babu Rangisetty, CEO at Biophore, says, “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. 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”
Mr. Rameswara Rao Chandana, Chairman of Rakshit Group, says, “Rakshit Group’s subsidiary, Sainor Laboratories, is the largest manufacturer of Lithium HMDS in India with a capacity of 500 MT 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”.
About Biophore India Pharmaceuticals:
Founded in 2007, Biophore India Pharmaceuticals is an established pharmaceutical company that develops and manufactures niche pharmaceutical products for the generic industry. Biophore’s state-of-the-art, multipurpose manufacturing facilities in Visakhapatnam comply with cGMP standards and meet the requirements of US and EU Drug regulatory authorities. Its technology development center in Hyderabad is equipped with infrastructure that facilitates the entire process of drug research from conceptualization to regulatory submissions. Biophore’s portfolio is spread across 30 therapeutic segments and specializes in development and manufacturing of pharmaceutical actives for Oncology medication, Contrast and Diagnostic media. To date, the company has filed about more than 100 drug master files and 150 patents for its unique portfolio.
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