Synmosa Plant Passes Inspection by South Korea's Ministry of Food and Drug Safety

Date:2015.11.17

Synmosa Biopharma (TPEx:4114) announced that its dedicated production plant for sex hormone pharmaceuticals has successfully passed South Korea's Ministry of Food and Drug Safety (MFDS) plant inspection for foreign manufacturers. The plant was granted a certificate of pharmaceutical product (CPP) for distributing the synthetic progestogen compound levonorgestrel in South Korea under the registered brand name SafeOne-Plus® (1.5 mg tablets). By collaborating with local South Korean drug manufacturer Kwang Dong Pharmaceutical, Synmosa is now moving full speed ahead with its plan to expand into the South Korean pharmaceutical market.

The Synmosa Group's dedicated plant for producing hormone products previously passed an assessment in 2011 by the Taiwan Food and Drug Administration (TFDA) to ensure PIC/S GMP compliance. Now, after successfully passing inspection by South Korea's Ministry of Food and Drug Safety, the plant is continuing its R&D on various pharmaceutical products and vigorously expanding distribution into new global markets. Currently, the plant is already responsible for producing Antilin® (levonorgestrel), the leading brand of emergency contraception drugs sold in Taiwan. Synmosa Biopharma's favorable outlook in South Korea was further amplified in October 2016 after completing MFDS's review and approval process for pharmaceutical product registration, approval of GMP documentation and procedures, and on-site plant inspection.

According to initial estimates, similar classes of pharmaceutical products sold in South Korea boast a market value of as much as NT$250 million (about US$8.2 million) and have shown steady annual growth. Seeing this lucrative window of opportunity, Synmosa inked a sales and distribution agreement with South Korean company Kwang Dong Pharmaceutical in 2013, allowing Synmosa to secure registration for levonorgestrel production. Kwang Dong Pharmaceutical specializes in the manufacture and sale of various pharmaceutical products and has recorded rising revenue in recent years. The cooperation between these two companies marks a synergistic alliance which plays to the strengths of both sides, and it is anticipated that the sale of SafeOne-Plus® in South Korea will be an exceptionally profitable endeavor for all parties.