The drug can be out there as a 200 mg pill at a most retail value (MRP) of Rs 3,500 for a strip of 34 tablets, Glenmark Prescription drugs mentioned.
FabiFlu is the primary oral favipiravir-approved medicine in India for the therapy of Covid-19, it mentioned in an announcement.
It’s a prescription-based medicine, with beneficial dose being 1,800 mg twice each day on day one, adopted by 800 mg twice each day as much as day 14, it added.
The tablets are being produced by the corporate at its Baddi facility in Himachal Pradesh. The drug can be out there each by means of hospitals and the retail channel, Glenmark mentioned.
Extra on Covid-19
The Mumbai-based agency had on Friday acquired the manufacturing and advertising and marketing approval from the Medicine Controller Normal of India (DCGI).
“This approval comes at a time when instances in India are spiralling like by no means earlier than, placing an amazing stress on our healthcare system,” Glenmark Prescription drugs chairman and managing director Glenn Saldanha mentioned within the assertion.
The corporate hopes that the provision of an efficient therapy reminiscent of FabiFlu will significantly assist assuage this stress, and provide sufferers in India a a lot wanted and well timed remedy choice, he added.
“Glenmark will work carefully with the federal government and medical neighborhood to make FabiFlu shortly accessible to sufferers throughout the nation,” he added.
The corporate has efficiently developed the lively pharmaceutical ingredient (API) and the formulation for FabiFlu by means of its in-house analysis and improvement staff, Glenmark mentioned.
“We selected to provoke work on Favipiravir, because it has confirmed in-vitro exercise in opposition to SARS CoV2 virus, which is the virus chargeable for Covid-19.
“Second is it has a large therapeutic security margin for Covid-19 on the dose that we administer,” Glenmark Prescription drugs president India Formulations, Center East and Africa Sujesh Vasudevan mentioned at an internet press convention.
Furthermore, it’s an oral product and that may be a enormous profit particularly when the hospital infrastructure is below pressure, he added.
Manufacturing and advertising and marketing approval has been granted as a part of an accelerated approval course of, contemplating the emergency scenario of the Covid-19 outbreak in India, Glenmark mentioned.
The approval’s restricted use entails accountable medicine utilization the place each affected person will need to have signed knowledgeable consent earlier than therapy initiation, it added.
Favipiravir can be utilized for coronavirus sufferers with co-morbid situations reminiscent of diabetes and coronary heart illness with delicate to reasonable Covid-19 signs, Glenmark mentioned.
It presents speedy discount in viral load inside 4 days and supplies sooner symptomatic andradiological enchancment.
Favipiravir has proven medical enchancment of as much as 88 per cent in delicate to reasonable Covid-19 instances, it mentioned.
Favipiravir has been authorised in Japan since 2014 for the therapy of novel or re-emerging influenza virus infections.
Final month, Glenmark additionally introduced that it’s conducting one other medical trial to guage the efficacy of two antivirals Favipiravir and Umifenovir as a mix remedy in reasonable hospitalised grownup Covid-19 sufferers in India.
India on Saturday noticed one other file spike of 14,516 new Covid-19 instances in a single day, pushing the tally to three,95,048, whereas the demise toll rose to 12,948 with 375 new fatalities, in response to Union well being ministry information.
In Video:Glenmark launches Covid drug after DCGI nod; MRP at Rs 103 per tablet