Korea’s Janssen produced PPI, approved for relocation of the manufacturer to Genuone Sciences
Laying the foundation for expanding global partnerships with the start of Esai product licensed production
[팜뉴스=이권구 기자]Genuone Science (CEO Mi-yeon Kim, hereinafter Genu1), the No.1 pharmaceutical company in Korea, has granted permission from the Ministry of Food and Drug Safety to change the manufacturing source for the manufacture of 10mg and 20mg products of the original pharmaceutical product of Ezai, a Japanese global pharmaceutical company. He said on the 9th that he had received it.
Genuine 1 is the first to license and produce original medicines from global pharmaceutical companies in the consignment production centered on generic products, and this is the first feat since Genuine 1 was launched.
Pariet Tablet is Ezai’s original PPI (Proton Pump Inhibitor) medicine, and is used to treat gastric ulcer, duodenal ulcer, gastroesophageal reflux disease, etc. The amount of outpatient prescriptions for Parisette based on UBIST is 12.4 billion won in 2017, 13 billion won in 2018, and 13.3 billion won in 2019, which is one of the high demand drugs. In Korea, Janssen Korea first licensed and produced it in 2000, and after Ezay Korea started direct business with the copyright of Parisette, the manufacturer changed to Genuone.
The pharmaceutical division of Kolmar Korea, the predecessor of Genuine One, has been working hard for many years to successfully convert the manufacturing source, such as receiving approval for 10mg and 20mg products of Parisette tablets from Janssen Korea in April 2020. In collaboration with Janssen Korea and Ezai in Japan, the transfer of manufacturing technology and analytical technology was carried out, and the final approval was obtained for the transfer of the manufacturing company from Janssen Korea to Genuone Science through a bioequivalence test.
In particular, in the process of transferring the manufacturing technology of 10mg and 20mg of Pariset tablets, Japan Ezai, the original developer, provided technical support at a global level through strict management. In order to maintain the excellent quality of the original product, Genuine1 proved the quality of production management and obtained the approval of the original developer, and the process was optimized to lead to high production efficiency.
With this permission to change the manufacturer, Genuone will produce the entire process of 10mg and 20mg products of Parisette tablets, and it is set to ship for the first time in April.
Mi-yeon Kim, CEO of Genuine One, said, “This permit passed the verification of Japan Ezai, a global partner, and served as an opportunity to prove Genuine’s quality and production level. “We will not spare any investment in Korea.”
He also said, “Starting with the production of Parisette tablets, we will further strengthen our partnership with Ezay in Korea and strive to expand partnerships with global pharmaceutical companies.”
Genuone Sciences, launched in December last year, is the No. 1 CMO company in Korea in the pharmaceutical sector, created by acquiring Kolmar Korea’s pharmaceutical division and Kolma Pharma.
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