Samil Pharm secures GMP certification for Vietnam eye drop CDMO plant

Samil Pharmaceutical, a Korean drugmaker listed on the Kospi, announced that its eye drop CDMO (Contract Development and Manufacturing Organization) plant in Ho Chi Minh City, Vietnam, has received Good Manufacturing Practice (GMP) certification from the Drug Administration of Vietnam (DAV).

With this certification, Samil Pharmaceutical's eye drop CDMO plant in Vietnam is now officially authorized to produce pharmaceutical products. The plant, located in the Saigon Hi-Tech Park (SHTP) in Ho Chi Minh City, spans a total area of 25,000 square meters. It features three production wings and four office wings.

The main production facilities at Samil Pharm’s Vietnam CDMO plant include two Blow-Fill-Seal (BFS) filling machines from Rommelag, a German company, with a capacity of approximately 130 million doses per year. Additionally, the plant houses a multi-filling machine from Groninger, another German company, with the ability to produce around 40 million bottles per year. Combined, these machines enable the production of about 300 million doses of eye drops annually. Currently, production is being conducted across three lines, with plans for scalability to add five more lines in the future, bringing the total number of production lines to eight.

The company highlighted that its plant is equipped with state-of-the-art automation facilities, including high-speed automatic packaging lines from Uhlmann (Germany), weighing booths from Weiss (Germany), and isolators from Comecer (Italy). For the multi-filling machines, Samil Pharmaceutical developed and introduced the “world's first” feeding device in collaboration with Franziel (Germany). This device uses a VHP (Vaporized Hydrogen Peroxide) sterilization system, enhancing sterility stability while reducing production costs.

In addition to obtaining GMP certification in Vietnam, Samil Pharmaceutical is also pursuing Korean GMP certification from the Ministry of Food and Drug Safety. The company plans to begin the process for U.S. cGMP and EU-GMP certification soon, with the goal of achieving these certifications by the end of 2026.

Samil Pharm specializes in eye diseases and has extensive experience in producing ophthalmic drugs through partnerships with multinational pharmaceutical companies such as Allergan and THEA from France. Building on this expertise, the company aims to secure business stability and enhance price competitiveness by leveraging Vietnam’s abundant labor force. With these advantages, Samil plans to maximize growth through its global eye drop CDMO plant in Vietnam.

A company official stated, "We are in discussions regarding partnerships and CMO orders with several companies. Our goal is to supply high-quality eye drops at competitive prices to various countries, including Korea and Vietnam, as well as Southeast Asia and South America." They added, "We have a bright outlook for the business due to global drug price reductions, including in the U.S., and the growing reliance on CMOs worldwide."

According to global market research firm BMI Research, Vietnam's pharmaceutical market was valued at $6.5 billion in 2023, with an expected average annual growth rate of 10.3 percent over the next five years.