AstraZeneca Korea earns Consignment Business Authorization

Adds another type of business under its name for the COVID-19 vaccine to be manufactured by SK Bioscience

AstraZeneca Korea earned the seventh ‘Pharmaceutical Consignment Manufacturing Business Authorization’ in South Korea due to the COVID-19 vaccine manufactured by SK Bioscience.

 

South Korea’s Ministry of Food and Drug Safety (MFDS) reported AstraZeneca Korea has been authorized for a pharmaceutical consignment manufacturing business on Feb.10.

 

On the same day, the South Korea’s first approved COVID-19 vaccine, ‘AstraZeneca Korea Covid-19 Vaccine injection’ was also authorized for the market.

 

The licensor of the vaccine is AstraZeneca Korea, but it would be manufactured by SK Bioscience.

 

Prior to receiving a pharmaceutical license, the supplier has to be licensed as a manufacturer or an importer.

 

And an approved manufacturer in South Korea can apply for an approval on domestically marketed drug or export-only drug.

 

A company licensed as an importer can also apply for an approval on an internationally imported drug.

 

So far, AstraZeneca Korea was only licensed as a pharmaceutical importer in South Korea as of 2016.

 

Up until Feb.

 

10, the multinational company had total of 65 licensed drugs all imported.

 

But the company needed another business license as it manufactures the COVID-19 vaccine authorized on Feb.

 

10 since last July through a consignment deal signed with SK Bioscience.

 

In 2007, MFDS newly established the Pharmaceutical Consignment Manufacturing Business Authorization for such company without a manufacturer in South Korea to receive the pharmaceutical authorization.

 

With the license, a company can apply for an approval on an item manufactured with consignment contract.

 

The first authorization was earned by GL Pharm Tech (CEO Wang Hunsik) in September 2008.

 

The company owns licenses over four items including G-Soren tablet, manufactured by Richwood Trading Company.

 

Another multinational pharmaceutical company MSD Korea (CEO Kevin Peters) also took the second authorization in 2009.

 

MSD Korea owns licenses over three items including an anti-hypertension drug Cozaar XQ tablet, manufactured by Hanmi Pharmaceutical.

 

Corepharm Bio, Crystal Genomics, Abbott Korea, Geongang Pharmaceutical and AstraZeneca Korea are the rest of companies with the consignment business authorization.

 

Other companies to supply COVID-19 vaccine should be licensed in South Korea.

 

Pfizer and Janssen have no issue as they are already licensed as an importer, and would import their vaccines.

 

But for Novavax, who licensed out the technology to SK Bioscience, would have the South Korean company to be in charge of the approval and distribution.

 

As for a company without a license in the country like Moderna, it would have to open a branch in South Korea to apply for the imported vaccine use authorization, or to license out for the co-promotion deal to a Korean company like Novavax.