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Optimus Pharma receives DCGI approval for oral antiviral Favipiravir Tablets, for the treatment of mild to moderate COVID 19

by Marshaneil Soumi D’ Rozario | July 29th, 2020

optimus pharma receives dcgi approval for oral antiviral favipiravir tablets, for the treatment of mild to moderate covid 19
 Image used for representational purpose only

HYDERABAD:24th July 2020: Optimus Pharma Pvt. Ltd. (Director: P. Prashanth Reddy, “Optimus Pharma”) announced today that the Hyderabad-based company received approval from Drugs Controller General of India (DCGI) for manufacturing the Active Pharmaceutical Ingredient (API) Favipiravir through its subsidiary, Optrix Laboratories, and 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, Optimus Pharma added.

 

“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 at Hyderabad, Telangana (India). The drug will be available both through hospitals and the retail channel, Optimus added.

 

Favipiravir has strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum anti-viral (RNA viruses) with clinical improvement. It offers rapid reduction in viral load within 4 days of starting of treatment and provides faster symptomatic and radiological improvement.

 

Optimus Pharma initiated work on Favipiravir – as early as January, 2020, because of this drug’s proven in-vitro activity against SARS-CoV 2 virus, which is the virus responsible for COVID-19 and successfully developed the active pharmaceutical ingredient (API) and the formulation for Favipiravir tablets through its own in-house R & D team.

 

Favipiravir is originally approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action: it is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.

 

Speaking about this mile stone, Mr. Prashanth Reddy P, Director of Optimus Pharma Pvt. Ltd., said, “Approval from India’s drug regulator is at right time when the cases of Covid 19 are increasing rapidly and there is an unmet need of treatment options. Favipiravir tablets are advantageous for patients for their ease of administration over intravenous injections. Optimus Pharma will work with other major Pharma Companies, government and hospitals to make FAVICOVID quickly accessible to patients across the country at an affordable price”.

 

Mr. Prashanth reddy added that “In addition to domestic supply, Optimus is already exporting the Favipiravir Tablets globally and further we are looking at supplying the FAVICOVID tablets through government bodies and well”.

 

About Optimus group

 

Optimus Pharma Pvt. Ltd., is a research oriented pharmaceutical company with presence in over 100 countries including the USA, EU and Japan. Optimus is currently a leading player in Anti-Diabetic, Anti-Fungal, Hepatitis, Gastro, CNS disorders.

 


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