Covid 4th Wave? 19 Indian Firms Will Make Oral Covid-19 Antiviral Drug Created By Pfizer
In order to manufacture the generic version of Pfizer’s oral COVID-19 antiviral nirmatrelvir, as many as 19 drugmakers in India have signed sublicence agreements with the United Nations-backed Medicines Patent Pool (MPP). This antiviral is to be used in combination with ritonavir.
35 Companies Across 12 Countries Signed the Contract
There are a total of 35 companies across 12 countries who have signed such a contract with MPP for manufacturing and supplying to 95 low and middle income countries. The non-exclusive sublicences allow the generic manufacturers to produce raw ingredients for Nirmatrelvir and/or the finished drug itself co-packaged with Ritonavir.
The agreements follow the voluntary licensing agreement MPP and Pfizer signed in November 2021. Under the name of Paxlovid, Pfizer is marketing its oral COVID-19 treatment. Paxlovid has received emergency use/conditional authorisation from USFDA and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Out of total 35, 6 companies shall produce the drug substance whereas 9 shall produce the drug product. Remaining 20 companies shall do both.
Notably, as long as COVID-19 remains classified as a Public Health Emergency of International Concern by the WHO, Pfizer shall not receive royalties from sales of nirmatrelvir from the MPP sublicensees.
MPP said the companies offered the sublicence demonstrated their ability to meet its requirements related to production capacity, regulatory compliance, as well as international standards for quality-assured medicines.
MPP Executive Director Charles Gore said that “Nirmatrelvir is a new product and requires substantial manufacturing capabilities to produce. We have been very impressed with the quality of manufacturing demonstrated by these companies.”
List of 19 Drug Makers
- Sun Pharma
- Aurobindo Pharma
- Torrent Pharma
- MSN Pharma
- Laurus Labs
- Divis Laboratories
- Arene Lifesciences
- SMS Pharmaceuticals