Local Philippines drugmaker ready to make COVID treatment pill

[Jollygoodfellow]

How long do you think it will take to be approved? 

...........................................

A local manufacturer said it could produce huge volumes of a pill used to treat mild and moderate cases of COVID-19 infections, promising to do it as early as within a week of getting the necessary approval from the Food and Drug Administration (FDA).

Top officials of Lloyd Laboratories Inc. told reporters last Thursday that it can make around a million capsules of molnupiravir per batch, using technology that came from a pharmaceutical company in India, with each batch taking a few days to finish.

Once manufactured, the capsules—which, according to the officials, will be priced 30 percent to 50 percent cheaper than competition—will be made available to hospitals and institutions, who would prioritize the supply for COVID-19 patients with comorbidities.

The manufacturing capacity is already in place. All that’s left is to get the FDA’s approval for an emergency use authorization, or an EUA, which is issued for unregistered drugs and vaccines in a public health emergency. Company officials say the application process, which began sometime in October last year, is ongoing.

Done in a week
“It depends on the Philippines FDA. For example, if Philippines FDA gives the clearance by tomorrow, barely within five to seven days we can make the product available to the market,” said Dr. Chandra Shekhara Reddy Nagareddy, company vice president.

This developed as the public continues to struggle with the pandemic, with the coronavirus evolving into other variants, while the government’s response measures, like contact tracing and testing, keep falling behind even after two years.

Lloyd Laboratories acquired a direct technology transfer for the production of molnupiravir from Optimus Pharma, a pharmaceutical company based in India. The company has actually already been supplying one local hospital with molnupiravir through a compassionate special permit, or CSP.

The Board of Investments (BOI), which had recently approved Lloyd’s application for tax breaks, said that the company would be supplying Recuenco General Hospital in Metro Manila until November this year. The BOI said the approved project, located in Bulacan province, costs close to P24 million.

Christopher Bamba, company director for business development, said the hospital had so far only gotten around 600 out of the 10,000 capsules allotted for them under the CSP. He said it started supplying the hospital last week, noting that the orders are expected to increase over time.

“If you have the EUA, then we will be able to distribute it to hospitals and even institutions without them applying for anything,” Bamba said during the interview, adding that the company “will be able to serve all hospitals who will require it.”

When asked if the company had an estimate on the demand for the product, Bamba said the figure was still based on a rough computation.

“Based on the active cases in the Philippines as of two days ago, 3.6 million capsules are required to treat at least 20 percent of the active COVID-19 cases,” he replied, noting that they can meet the demand. 

https://newsinfo.inquirer.net/1540314/local-drugmaker-ready-to-make-covid-treatment-pill

[scott h]

1 hour ago, Jollygoodfellow said:

How long do you think it will take to be approved? 

Depends if any major stock holders work for the Department of Health, or the IATF....., if they are,,,,probably tomorrow 

[Snowy79]

Going to be fun if that drug gets into the general public. It apparently makes mutation of the virus more active which so far has been shown to weaken the virus leading to it dying off but the mutations need to be contained in a strict clinical environment to prevent escape.

[Jollygoodfellow]

59 minutes ago, Snowy79 said:

Going to be fun if that drug gets into the general public. It apparently makes mutation of the virus more active which so far has been shown to weaken the virus leading to it dying off but the mutations need to be contained in a strict clinical environment to prevent escape.

So your saying we can not win 

[Joey G]

1 hour ago, Snowy79 said:

It apparently makes mutation of the virus more active which so far has been shown to weaken the virus leading to it dying off but the mutations need to be contained in a strict clinical environment to prevent escape.

But if the mutations don't escape... how will we ever get the benefit of a weaker virus?????? Or is that how we got here in the first place? 

[GeoffH]

11 hours ago, Joey G said:

But if the mutations don't escape... how will we ever get the benefit of a weaker virus?????? Or is that how we got here in the first place? 

There is no guarantee that a future mutation will be weaker (assuming you're talking about how sick people get).

[Snowy79]

11 hours ago, Joey G said:

But if the mutations don't escape... how will we ever get the benefit of a weaker virus?????? Or is that how we got here in the first place? 

Remember Delta also escaped. 

[Old55]

18 minutes ago, Snowy79 said:

Remember Delta also escaped. 

Not so sure about that Snowy. Allegedly many people caught Delta. 

[Snowy79]

3 hours ago, Old55 said:

Not so sure about that Snowy. Allegedly many people caught Delta. 

I'm sure if the first person to carry the mutation for Delta was quarantined until they had been completely cured there would have been zero spread. 

I can see a few wealthy people self medicating on some of these drugs and nipping out for the odd social event before getting the all clear and spreading the love.  

[OnMyWay]

I don't understand how the Philippines and these other countries can start making it without permission from Merck.  Also, there is a lot of controversy surrounding it.

Thailand and Indonesia unveil plans to develop molnupiravir COVID-19 pill

BANGKOK/JAKARTA, Jan 14 (Reuters) - Thailand's health minister said on Friday the country planned to develop the anti-viral pill molnupiravir to combat COVID-19 infections amid rising infections driven by the Omicron variant.

The molnupiravir COVID-19 treatment pill for adult patients at risk of developing severe illness was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics.

The Southeast Asian nation intends to join other countries in the region also planning to make versions of the drug including Bangladesh and India.

"For molnupiravir, the Government Pharmaceutical Organization has plans to co-develop (this drug) with the Chulabhorn Research Institute," Minister Anutin Charnvirakul told a news conference.

"A committee will research and produce the reactants, which will be additional support for future events," he said.

Separately, Indonesia's health minister Budi Gunadi Sadikin said on Friday the country also planned to develop molnupiravir in partnership with pharmaceutical company PT. Amarox Pharma Global starting in April or May.

Indonesia approved molnupiravir for emergency use this week and 400,000 pills have arrived. read more

Thailand has ordered 50,000 courses of molnupiravir from Merck and was still in discussion with Pfizer (PFE.N) for 50,000 courses of its drug Paxlovid.

https://www.reuters.com/world/asia-pacific/thailand-indonesia-unveil-plans-develop-molnupiravir-covid-19-pill-2022-01-14/