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(Photo= Yonhap news) |
[Alpha Biz= Reporter Kim Sangjin] Samil Pharmaceutical announced on the 26th that its global eye drop contract development and manufacturing organization (CDMO) plant located in Ho Chi Minh City, Vietnam, has received Good Manufacturing Practice (GMP) certification from the Vietnamese Drug Administration (DAV).
With this certification, Samil Pharmaceutical's Vietnam CDMO plant is officially authorized to produce pharmaceuticals. The facility, situated in the Saigon Hi-Tech Park (SHTP), spans an area of 25,000 square meters with a total floor area of 21,000 square meters, featuring a three-story production building and a four-story office building.
Key production equipment includes two BFS (Blow-Fill-Seal) machines from the German company Rommelag, capable of producing approximately 130 million doses annually, and one multi-filler machine from Groninger, also from Germany, which can produce around 40 million bottles per year. This allows for a total production capacity of approximately 300 million eye drops annually. Currently, production is being carried out on three lines, with plans to expand to a total of eight lines in the future.
In addition to the GMP certification in Vietnam, the company is also in the process of obtaining kGMP certification from the Korean Ministry of Food and Drug Safety, with plans to initiate the cGMP and EU-GMP certification processes for the United States and Europe by the end of 2026.
AlphaBIZ Kim SangJin(letyou@alphabiz.co.kr)
