Sunny Pharmtech (祥翊製藥) announced on the 18th that its Phytonadione Injectable Emulsion USP (PTD-I, 1mg) for Vitamin K1 deficiency received US FDA approval on January 12.

• US Pipeline: Three additional products—CIT-I, CLB-T, and NTN-SC—are awaiting approval in 2026. Notably, NTN-SC, targeting pulmonary fibrosis, addresses a US market estimated at US$2.7 billion.
• International Reach: Chairman Dr. Percy Wu highlighted the "One Drug, Multiple Licenses" strategy, expanding FDA-approved drugs into the UK, MENA, and Malaysia.
• Domestic Milestones: In Taiwan, ITN-SC (for severe acne) received approval in late 2025, marking the company’s formal entry into its home market.
• CDMO Growth: With over 40 active projects across the US, Japan, and Taiwan, Sunny Pharmtech’s CDMO/CMO business continues to provide stable revenue streams.

Resource: 祥翊製藥2026年開春報喜 取得美國FDA核准PTD-I藥證