Genuone Sciences announced on the 9th that it has received permission to change the manufacturer for the manufacture of 10mg and 20mg Pariset tablets from the Ministry of Food and Drug Safety.
Pariet Tablet is a proton pump inhibitor (PPI) from Ezai, Japan, and is an original medicine used for the treatment of gastric ulcer, duodenal ulcer, and gastroesophageal reflux disease. The amount of outpatient prescriptions based on UBIST is 12.4 billion won in 2017, 13 billion won in 2018, and 13.3 billion won in 2019.
In Korea, it was first licensed and produced by Janssen Korea in 2000, and the manufacturer changed to Genuone after Ezai Korea started direct sales with the copyright. Genuine explained, “We are the first to license and produce original drugs from global pharmaceutical companies in the consignment production centered on generic products.”
With the approval of the Ministry of Food and Drug Safety to change the manufacturing source, Genuone will produce the entire process of 10mg and 20mg products of Parisette tablets, and the first shipment is expected in April.
The Kolmar Korea Pharmaceutical Division, the predecessor of Genuone, has been carrying out preliminary work for the conversion of manufacturers, such as receiving product licenses for 10mg and 20mg of Parisette tablets from Janssen Korea. In collaboration with Janssen Korea and Ezai, Japan, the transfer of manufacturing and analysis technology was carried out, and the final approval was obtained for the transfer of the manufacturing company from Janssen Korea to Genuine Sciences through a bioequivalence test.
Kim Mi-yeon, CEO of Genuine 1, said, “This permit passed the verification of Japan’s Ezai, a global partner, and thus served as an opportunity to prove the quality and production level of Genuine.” I will continue to invest in it.”
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