Strides Pharma Science Ltd on Tuesday said it will immediately launch its generic Molnupiravir, indicated for high-risk adult patients with COVID-19, in India under the brand Stripiravir.The company has received Emergency Use Authorisation from the Drugs Controller General of India (DCGI) to launch Molnupiravir 200mg, an oral medication for COVID-19, in India.In a statement, Strides said it will “immediately launch Molnupiravir in India under its brand Stripiravir”.The company is commercialising the product with a group integrated supply chain for Active Pharmaceutical Ingredients and solid oral dosage from its large-scale WHO Pre-Qualified (PQ) manufacturing capacities, it added.
“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,” Strides Pharma Science Ltd Managing Director and CEO R Ananthanarayanan said.
With the emergence of the new variants, he said, “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 authorities granted restricted emergency use approval to Molnupiravir for the treatment of adult patients with COVID-19 and who have a high risk of progression of the disease.
Strides said Molnupiravir has been granted approval by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a safe and effective medication for patients with mild to moderate cases of COVID-19. It also recently received the USFDA’s Emergency Use Authorisation.