Ohsong Pharm Co., Ltd. (CEO Kim Young-joong), a company specializing in pharmaceutical exports to Japan, announced on the 5th that its subsidiary, Brio Pharma, has received  Japan’s Class 2 Medical Device Manufacturing and Marketing License from the Pharmaceuticals and Medical Devices Agency (PMDA).
Brio Pharma, a local subsidiary established in Tokyo, Japan, in 2017, became wholly owned by Osong Pharm, Inc. in 2018 and has obtained Class 1 and 2 Medical Device Manufacturing and Marketing Licenses in Japan.
This achievement has paved the way for Ohsong Pharm to become the only Korean pharmaceutical company to independently enter Japan's advanced drug market.
Building on this foundation, Ohsong Pharm, through Brio Pharma, obtained PMDA approval in August 2022 for Korea’s first in-house-developed generic osteoporosis drug, Ibandronate Pre-filled Syringe Injection.
In February this year, the company also received approval for escitalopram tablets, an SSRI antidepressant co-developed with Whan In Pharm. With Brio Pharma's acquisition of a medical device company license, Ohsong Pharm has expanded its business scope beyond pharmaceuticals to include medical devices.
An Ohsong Pharm representative said, ‘Obtaining a medical device company license in Japan requires specialized personnel, including a general sales manager, quality assurance manager, and safety management manager at the local subsidiary. Brio Pharma has successfully met PMDA requirements by employing experienced and specialized personnel.’
Furthermore, the representative said, ‘While we don’t have a development organization or manufacturing facilities, our products are developed under an open innovation model. This approach allows us to collaborate with leading domestic and international developers to create Japan-oriented products, which are then approved by the PMDA through our subsidiary, Brio Pharma. Looking ahead, we plan to expand our Japan-focused portfolio to include medical devices alongside pharmaceuticals, further strengthening our position as a specialized pharmaceutical company in Japan.