Generic for Paxlovid PQ certification for 1 year

10 pharmaceutical companies attempting WHO certification

Acquired PQ from Hetero Labs in India last December

As of March 22, 2022, the number of pharmaceutical companies that introduced Paxlovid

Among the 36 pharmaceutical companies that have introduced Paxlovid's generic license for an edible COVID-19 treatment, some companies are attempting World Health Organization (WHO) pre-qualification (PQ) certification.

 

Each pharmaceutical company is expected to obtain PQ certification even after the COVID-19 emergency is lifted and supply medicines to developing countries through public bidding.

 

According to the WHO on the 26th, one out of 36 pharmaceutical companies that introduced Paxlovid's generics received WHO PQ certification.

 

Indian pharmaceutical company Hetero obtained the first generic for Paxlovid PQ certification in December last year.

 

Nine pharmaceutical companies, including Celltrion, are in the process of PQ approval.

 

These include Fosun Pharma, Mylan, Desano, Strides Pharma Science, Xinjin, Yao Pharmaceutical, Zhejiang Apeloa, and Zhejiang Huahai.

 

Pfizer received WHO PQ certification for its original Paxlovid product.

 

For PQ certification, WHO is conducting ▲an advisory meeting ▲pre-document submission meeting ▲receipt of evaluation documents.

 

Celltrion, Fosun Pharmaceutical, Mylan, Zhejiang Apeloa, and Zhejiang Huahai have gone through all three procedures and are waiting for approval.

 

Desano and Strides pharma science even proceeded with the meeting process before submitting the documents.

 

Xinjin and Yao Pharmaceutical held a meeting to receive advice from the WHO.

 

The WHO PQ is a system that certifies the safety and effectiveness of medicines by evaluating the manufacturing process, quality, and clinical results.

 

Pharmaceutical companies that have secured PQ certification are qualified to participate in international bidding for medicines organized by organizations affiliated with the United Nations (UN), such as UNICEF and the Pan-American Health Organization.

 

WHO PQ certification is one of the ways to advance into developing countries through international bidding.

 

The International Pharmaceutical Patent Pool (MPP) granted licenses for Paxlovid's generics to 36 companies in 13 countries in March last year.

 

It is a measure following the fact that Pfizer allowed the sale of Paxlovid generics to low- and middle-income countries such as developing countries through MPP.

 

Celltrion secured a license for Paxlovid's generic finished product.

 

Celltrion Pharmaceuticals, an affiliate, is responsible for the development and production of finished products.

 

Celltrion is in charge of overseas supply.

 

Product production is carried out at Celltrion Pharmaceutical's Cheongju plant, which is a cGMP-certified facility.

 

Paxlovid is an oral antiviral drug in pill form.

 

In a phase 2/3 clinical trial conducted by Pfizer, it was confirmed that the rate of hospitalization and death due to COVID-19 was reduced by 89% compared to the placebo group.

 

The WHO strongly recommended the prescription of Paxrovid for patients with mild or moderate COVID-19.

 

Approval for use has been obtained and prescriptions are being made in major countries around the world, including the United States and the EU.

 

According to an October 2021 survey by the WHO, the market for generic procurement of edible COVID-19 treatments to be supplied to low- and middle-income countries is estimated at 1.7 trillion won.