Samil Pharmaceutical Vietnam Eye Drop CDMO Factory Completes GMP Certification from Vietnam Drug Administration

Samil Pharmaceutical announced on the 26th that its global ophthalmic CDMO factory located in Ho Chi Minh City, Vietnam, has received the 'Good Manufacturing Practice (GMP)' certification from the Vietnam Drug Administration (DAV).

With this certification, Samil Pharmaceutical's ophthalmic CDMO factory in Vietnam is now officially authorized to produce pharmaceuticals. The global ophthalmic CDMO factory of Samil Pharmaceutical was established in the Saigon Hi-Tech Park (SHTP) industrial complex in Ho Chi Minh City, Vietnam, with a factory site of 25,000㎡ and a total floor area of 21,000㎡, consisting of a three-story production building and a four-story office building.

Key production equipment includes two BFS fillers from Rommelag, Germany, capable of producing approximately 130 million doses annually, and one multi-filler from Groninger, Germany, capable of producing about 40 million bottles annually, enabling an annual production of approximately 300 million ophthalmic products. Currently, production is carried out on three lines, but there is scalability to add five more lines, allowing for a total of eight lines.

Additionally, the factory is equipped with world-class state-of-the-art automated facilities such as a high-speed automatic packaging line from Uhlmann, Germany, a weighing booth from Weiss, Germany, and an isolator from Comecer, Italy. Notably, for the multi-filler, a feeding device using the VHP sterilization system from Franziel, Germany, was developed and introduced for the first time in the world to enhance aseptic stability and reduce production costs.

The company stated that besides the Vietnam GMP certification, it is also undergoing the kGMP certification process with the Korean Ministry of Food and Drug Safety, and plans to initiate the US cGMP and European EU-GMP certification processes by the end of 2026.

Samil Pharmaceutical is a specialist pharmaceutical company in ophthalmology with extensive know-how and experience in producing ophthalmic drugs, and strong partnerships with global partners such as Allergan and the French company THEA. Based on this, the company plans to secure business stability and maximize growth through its global ophthalmic CDMO factory in Vietnam, leveraging the abundant labor force and price competitiveness of Vietnam.

A company representative said, “We are discussing partnerships and CMO orders with multiple companies. We will do our best to supply high-quality ophthalmic products with price competitiveness not only in Korea and Vietnam but also in various countries in Southeast Asia and South America,” adding, “With the global issue of pharmaceutical price reductions, including in the US, and the resulting increased global dependence on CMOs, we have a positive outlook on business feasibility.”

Meanwhile, according to a survey by the global market research firm BMI Research, the size of the Vietnamese pharmaceutical market was $6.5 billion (approximately 9.048 trillion KRW) last year, and the average annual growth rate over the next five years is estimated to be 10.3%. This is why leading Korean pharmaceutical and bio companies such as Celltrion are actively pursuing the establishment of sales joint ventures in Vietnam.

This content was produced with the assistance of AI translation services.