On Tuesday, Indian pharmaceutical company, Strides Pharma Science Ltd., said it would soon launch Stripiravir, a generic version of Molnupiravir, according to Financial Express Health Care.
Last week, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate COVID-19 in adults. The drug has also been approved for those who are at high risk for progression to severe COVID-19, including hospitalization or death.
Strides Pharma received Emergency Use Authorization from the Drugs Controller General of India (DCGI) to launch generic molnupiravir 200mg in India.
The company said in a statement that it will “immediately launch molnupiravir in India under its brand Stripiravir.” It is commercializing “the product with a group integrated supply chain for Active Pharmaceutical Ingredients (APIs) and solid oral dosage from its large-scale WHO Pre-Qualified (PQ) manufacturing capacities.”
Dr. R Ananthanarayanan, Managing Director and CEO of Strides Pharma, said, “We are delighted to receive the DCGI approval for launching Molnupiravir, which has shown promising results in several clinical studies. The product provides therapeutic benefit to the patients with mild-to-moderate COVID symptoms and can be administered at home.”
He explained that with the emergence of the new variants, “we believe molnupiravir will benefit the broad population, which could be at risk due to COVID-19. We remain committed in our fight against this global pandemic.”
Indian drug regulatory bodies and officials have granted restricted EUA to molnupiravir for the treatment of mild-to-moderate COVID-19 illness in adults and people who have a greater risk of progression of the disease, especially those who are immunocompromised.
Strides Pharma also said the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved molnupiravir, describing it as a safe and effective medication. Merck, known as MSD outside the United States, and Ridgeback Biotherapeutics are the first manufacturers of molnupiravir.