Preparing for Korean GMP Certification, Facility Set to Boost Production
Samil Pharmaceutical announced on July 15th that its global ophthalmic solution CDMO plant in Ho Chi Minh City, 카지노 꽁머니, has completed the inspection for 'Good Manufacturing Practice (GMP)' certification by the 카지노 꽁머니 Drug Administration.
The company is also preparing for an inspection to obtain GMP certification from the Korean Ministry of Food and Drug Safety (MFDS).
Samil Pharmaceutical's 카지노 꽁머니 plant, located in the Saigon Hi-Tech Park (SHTP) in Ho Chi Minh City, spans 25,000 square meters of land with a total floor area of 21,000 square meters. The facility features a three-story production building and a four-story office building.
Key production equipment includes two BFS fillers from Germany's Rommelag, capable of producing approximately 140 million doses annually, and a multi-filler from Germany's Groninger, capable of producing about 50 million bottles annually. Together, these allow the production of approximately 330 million units of ophthalmic solutions per year.
Currently, production is carried out on three lines, but there is potential for expansion to eight lines with the addition of five more lines in the future.
The facility is also equipped with state-of-the-art automation equipment, including a high-speed automatic packaging line from Germany's Uhlmann, a weighing booth from Germany's Weiss, and an isolator from Italy's Comecer.
Notably, the multi-filler system, developed in collaboration with Germany's Franziel, is the first in the world to incorporate a feeding device using the VHP sterilization system. This innovation enhances aseptic stability and reduces production costs.
The company anticipates that the 카지노 꽁머니 plant, which meets global GMP facility standards, will obtain 'WHO GMP (WHO Good Manufacturing Practice)' certification within three months, provided there are no significant issues following the DAV inspection.
According to 카지노 꽁머니's pharmaceutical regulations, the plant will receive both 'Form 19' and 'Form 1' GMP certificates, enabling it to supply products to both South Korean and international markets.
A report by global market research firm BMI Research indicates that the 카지노 꽁머니ese pharmaceutical market was valued at .5 billion last year, with an estimated average annual growth rate of 10.3% over the next five years.
This is why leading South Korean bio companies and pharmaceutical firms, such as Celltrion, are actively pursuing the establishment of local sales joint ventures in 카지노 꽁머니.
A company representative stated, "Our local partners in 카지노 꽁머니 have long desired to receive a large-scale supply of various ophthalmic solutions. However, due to the relatively lower pharmaceutical prices in 카지노 꽁머니 compared to Korea, our export volume has been limited by price competitiveness issues. Once the 카지노 꽁머니 plant becomes fully operational, we anticipate a significant increase in supply volume within 카지노 꽁머니 through enhanced price competitiveness."