FDA allows local manufacture of COVID-19 drug Molnupiravir

MANILA, Philippines — A local pharmaceutical firm has been given the go-signal by the Food and Drug Administration (FDA) to manufacture Molnupiravir, an oral antiviral drug against COVID-19.

At a public briefing yesterday, FDA acting director general Oscar Gutierrez said the agency has granted emergency use authorization (EUA) to Lloyd Laboratories, which can manufacture one million capsules of generic Molnupiravir per year.

These capsules are good for up to 50,000 COVID-19 patients, Gutierrez said.

He said there are two sources of COVID-19 medications in the Philippines: importation and local production.

“But most of the time, the supply of imported investigatory drugs with EUA that are arriving in the Philippines is limited,” Gutierrez said, citing Molnarz, which delivered three batches of COVID drugs.

Each batch contained 60,000 capsules, which are good for only 1,500 COVID patients.

The Molnupiravir capsules that will be produced by Lloyd will be used solely in the Philippines, according to Gutierrez.

He said they expect the prices of generic Molnupiravir to be cheaper by up to 70 percent per capsule.

Based on a market survey conducted by the FDA last month, Molnupiravir costs P100 to P150 per 200-mg capsule.

“Each patient will need 40 capsules to complete the required dosage in five days,” Gutierrez said.

Based on the EUA, the generic Molnupiravir can be procured only by the Department of Health and National Task Force against COVID-19.

Gutierrez also said the FDA is evaluating the application of Pfizer for EUA for Paxlovid, an antiviral drug given through intravenous infusion, which posted an efficacy rate of 88 percent against COVID-19 during clinical trials.