Optimus Pharma gets DCGI approval for Favipiravir
Updated: Jul 25, 2020
HYDERABAD, 24rd July 2020: Hyderabad based Optimus Pharma Pvt. Ltd. has received approval from Drugs Controller General of India (DCGI) for manufacturing the Active Pharmaceutical Ingredient (API) Favipiravir through its subsidiary, Optrix Laboratories.
While announcing this Prashant Reddy, Director of Optimus Pharma said that the compnay has recevied DCGI approval recently and it is very soon going to manufacture and market its antiviral drug, Favipiravir 200 mg tablets, through Optimus Pharma Pvt. Ltd. for the treatment of patients with mild to moderate COVID-19.
The company has leveraged it’s in-house capability to manufacture Active Pharmaceutical Ingredients (API), and it’s state-of-the art integrated research and manufacturing
operations to manufacture FDF (Finished Dosage Form) for Favipiravir 200 mg Tablets. Optimus Pharma will market this drug under the brand name, “FAVICOVID”, and will also use its specialized sales force to market and supply this antiviral drug on PAN-India basis through its subsidiary, Optimus Life Science Pvt. Ltd.
DCGI has granted manufacturing and marketing approval to Optimus Pharma for Favipiravir 200 mg tablets as part of an accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India. The approval for restricted use entails responsible medication of this drug, where every Covid-19 positive patient must have been informed and signed consent form before initiation of treatment.
“FAVICOVID” is a prescription-based medication, with recommended dose being 1,800 mg twice daily on day one, followed by 800 mg twice daily up to Day 14. Optimus Pharma is producing these tablets at its USFDA and WHO-GMP approved manufacturing facility in Hyderabad. The drug will be available both through hospitals and the retail channels.