Samjin Pharmaceutical Completes Osong Plant Raw Material Production Building and Injection Unit... "Expanding Localization of Key Drug Raw Materials"

Samjin Pharmaceutical Osong Plant. [Photo by Samjin Pharmaceutical]

[Asia Economy Reporter Lee Gwan-joo] Samjin Pharmaceutical announced on the 15th that it has completed the expansion of the currently operating Osong plant's 'API Raw Material Production Building' and the new establishment of the 'Injection Production Building.'

The Injection Production Building was completed with a total floor area of 10,105㎡ spanning from basement level 1 to the 3rd floor above ground, and the Raw Material Production Building was expanded to 5,149㎡ from basement level 1 to the 5th floor above ground. With an investment of 70 billion KRW, through this expansion and new construction, Samjin Pharmaceutical's Osong plant now has a total floor area of 16,339㎡ and production capacity three times greater than before. In the future, it will also serve as a foothold for pioneering new businesses through continuous collaboration with the Magok Research Center and the Hyangnam plant.

The Injection Production Building can produce injections that comply with the Ministry of Food and Drug Safety's 'Sterile Drug Manufacturing Standards under the Pharmaceutical Manufacturing and Quality Control Regulations' and the European Medicines Agency (EMA)'s 'Sterile Drug Manufacturing Process Guidelines (EU GMP Annex 1).' It is equipped with the latest systems including a 'Closed system' that reduces operator interference in the manufacturing process, an automatic gas sterilization system, automatic cleaning and sterilization systems, and machinery capable of communicating with IT systems for real-time process data acquisition and collection.

The Raw Material Production Building adopted the 'Quality by Design (QbD)' approach to ensure more thorough production process management. Additionally, by applying Process Analytical Technology (PAT), it enables manufacturing time reduction and subsequent cost savings. It also completed the foundation as a 'Smart Factory' by simultaneously producing raw materials required by the Hyangnam plant for new drug clinical raw materials and finished products, which require small-scale production.

Currently, the Osong plant produces seven major specialized raw materials including the antithrombotic agent 'Pleris Tablet (active ingredient Clopidogrel)' and hyperlipidemia treatments 'Newstatin AL Tablet (active ingredient Rosuvastatin)' and 'Newstatin A Tablet (active ingredient Atorvastatin).' The plan is to develop and produce more than 10 additional raw materials at the Osong plant in the future.

Choi Yong-joo, CEO of Samjin Pharmaceutical, stated, "Efforts to localize raw materials and improve self-sufficiency have a significant impact on supply stability and are strategic assets for future business by enhancing trust in our company's manufactured pharmaceuticals. We expect to demonstrate capabilities not only in responding to raw material input for our major products but also in expanding external supply chains and securing export routes, which will greatly contribute to the company's growth."