Hanmi Pharmaceutical's Gugu has been released in Japan as a treatment for prostate hypertrophy. Hanmi Pharmaceutical's partner Sandoz announced on June 23 that it will start full-scale sales in Japan under the name of "Tadalafil Tablets 2.5mg and 5mg ZA [SANDOZ]" in both 2.5mg and 5mg.
Sandoz was approved by Japan's Ministry of Health, Labor and Welfare in February as First Genetic for treating prostate hypertrophy (BPH).
Hanmi Pharmaceutical produces and supplies finished products of Tadalafil (2.5mg and 5mg) from its Paltan Smart Plant to Sandoz, which will carry out sales and marketing throughout Japan after final packaging.
Total BPH market for Tadalafil in Japan amounts to 74 million tablets (based on IMS in 2019). Hanmi Pharmaceutical plans to continue close cooperation with Sandoz with the aim of securing the largest share of Japan's BPH market.
"Gugu has become a leader in the domestic urology treatment market based on its excellent product quality and the trust of medical staff and patients," a Hanmi Pharmaceutical official said. "We will work closely with our partner, Sandoz, to achieve remarkable results in the new market."