Coronavirus Vaccine: Glenmark Launches Drug Covid After DCGI Assent; MRP to Rs 103 per tablet | India Business News
The drug will be available as a 200 mg tablet at a maximum retail price (MRP) of Rs 3,500 for a strip of 34 tablets, Glenmark Pharmaceuticals said.
FabiFlu is the first oral medication approved by favipiravir in India for the treatment of Covid-19, it said in a statement.
It’s a prescription drug, with a recommended dose of 1,800 mg twice a day on the first day, followed by 800 mg twice a day through day 14, he added.
The company produces the tablets at its Baddi facility in Himachal Pradesh. The drug will be available through both hospitals and the retail channel, Glenmark said.
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The Mumbai-based firm received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) on Friday.
“This approval comes at a time when cases in India are spiraling like never before, putting enormous pressure on our healthcare system,” Glenmark Pharmaceuticals President and CEO Glenn Saldanha said in the statement.
The company hopes that the availability of an effective treatment like FabiFlu will greatly help alleviate this pressure and offer patients in India a much-needed and timely therapy option, he added.
“Glenmark will work closely with the government and the medical community to make FabiFlu quickly accessible to patients across the country,” he added.
The company has successfully developed the active pharmaceutical ingredient (API) and formulation of FabiFlu through its in-house research and development team, Glenmark said.
“We chose to start work on Favipiravir, as it has shown in vitro activity against the SARS CoV2 virus, which is the virus responsible for Covid-19.
“Second, it has a wide therapeutic safety margin for Covid-19 at the dose we administer,” said Sujesh Vasudevan, president of Glenmark Pharmaceuticals, India Formulations, Middle East and Africa at an online press conference.
Furthermore, it is an oral product and is a great benefit, especially when the hospital infrastructure is under pressure, he added.
Manufacturing and marketing approval was granted as part of an expedited approval process, considering the emergency situation of the Covid-19 outbreak in India, Glenmark said.
Restricted use of approval implies responsible use of medications, where each patient must have signed the informed consent before starting treatment, he added.
Favipiravir can be used for coronavirus patients with comorbid conditions such as diabetes and heart disease with mild to moderate symptoms of Covid-19, Glenmark said.
It offers a rapid reduction in viral load in four days and provides a faster symptomatic and radiological improvement.
Favipiravir has shown a clinical improvement of up to 88 percent in mild to moderate cases of Covid-19, he said.
Favipiravir has been approved in Japan since 2014 for the treatment of new or re-emerging influenza virus infections.
Glenmark also announced last month that it is conducting another clinical trial to evaluate the efficacy of two antivirals, Favipiravir and Umifenovir, as combination therapy in moderate adult patients hospitalized with Covid-19 in India.
India recorded another record increase of 14,516 new cases of Covid-19 in a single day on Saturday, bringing the count to 3.95,048, while the number of deaths rose to 12,948 with 375 new deaths, according to data from the Ministry of Health of the Union.