[Asia Economy Reporter Hyunseok Yoo] Samsung Pharm announced on the 29th that its second factory, newly built as an exclusive plant for 'GV1001®', has received GMP (Good Manufacturing Practice) certification from the Ministry of Food and Drug Safety.
GV1001 is a new drug substance being developed by GemVax for the treatment of Alzheimer's disease, benign prostatic hyperplasia, and pancreatic cancer. With this manufacturing site approval, Samsung Pharm can supply between 40 million and up to 80 million vials annually from the second factory equipped with the latest production facilities and automation systems. This represents about a threefold increase in production capacity compared to the existing factory.
The second factory, located in the Hyangnam Pharmaceutical Complex in Hwaseong-si, Gyeonggi-do, was built with a total floor area of approximately 4,300㎡. About 20 billion KRW was invested in construction and facility funds for the factory’s GV1001-exclusive freeze-drying production line.
Samsung Pharm began the groundbreaking ceremony for the second factory at the end of 2018 and completed construction in March of this year. Since then, it has been conducting qualification evaluations of production and manufacturing support facilities and pre-GMP evaluation procedures by formulation groups to obtain GMP approval.
A company official stated, “With the acquisition of GMP certification and the full-scale operation of the second factory, productivity improvement and sales growth will be possible,” adding, “We will leverage the highly stable and high-quality production facilities and automation systems to secure competitiveness against other companies and use this as a stepping stone to grow into a mid-sized pharmaceutical company.”
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