Samil Pharmaceutical's ophthalmic solution CDMO plant in Vietnam has received GMP certification from the Vietnam Ministry of Health (DAV) and is ready for full-scale production. Industry analysts believe this facility will play a key role in driving the company's future growth.

On September 26, Samil Pharmaceutical announced that the certification allows official pharmaceutical production to commence at the Vietnam plant. The company established its local subsidiary in May 2018, and the plant's completion in November 2022 marks a significant milestone after nearly two years of preparation.

Samil, traditionally focused on South Korea, has been expanding its overseas presence to boost performance. The company aims to grow its ophthalmic product business globally by leveraging its expertise in ophthalmology.

The recently certified Vietnam facility features three production lines: two BFS filling machines with a combined capacity of 130 million units annually, and a multi-filling machine capable of producing 40 million bottles. In total, the plant can produce approximately 300 million units of ophthalmic solution annually. There is also potential to expand to five additional production lines, scaling capacity further.

The shift from exporting to local production in Vietnam is expected to boost output and improve performance, overcoming the limitations of past export volumes.

Additionally, the company is working toward securing kGMP certification from the Korean Ministry of Food and Drug Safety, with plans to complete cGMP certification in the U.S. and EU-GMP certification in Europe by 2026. These certifications would open doors to larger export markets, further enhancing growth potential.

However, industry experts caution that obtaining GMP certification in the U.S. and Europe could take longer due to stricter regulations, potentially delaying Samil's entry into these markets.

Despite this, Samil remains confident, emphasizing that cost competitiveness, driven by Vietnam’s lower labor costs, will give the company a significant advantage in expanding its sales and market presence.