TOT BIOPHARM is pleased to announce it has received accreditation from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a Foreign Manufacturer, specifically for “Biological Products.” This achievement marks a new chapter in the company's efforts to expand its Contract Development and Manufacturing Organization (CDMO) services in Japan.

The PMDA's Foreign Manufacturer Accreditation is a key regulatory requirement for overseas companies seeking to sell drugs, active pharmaceutical ingredients (APIs), or medical devices in Japan. Under Japan’s Pharmaceutical and Medical Device Act, all foreign manufacturers seeking to market drugs or medical products in Japan must obtain PMDA accreditation. The process involves a comprehensive review of manufacturing facilities and key personnel to ensure compliance with Japan’s regulatory requirements. With this accreditation, TOT BIOPHARM has demonstrated that its facilities meet the required standards, paves the way for the company to offer high-quality CDMO services in the Japanese market.

TOT BIOPHARM’s quality system already comply with the regulatory standards set by the U.S. FDA, and the European Medicines Agency (EMA), and China’s NMPA. Successfully passing the PMDA’s rigorous evaluation further reinforces the company's ability to provide GMP-compliant CDMO services in Japan. This milestone is expected to help TOT BIOPHARM provide stable, high-quality services to the Japanese market and strengthens the company’s position in its global expansion efforts.

“We are thrilled to have received PMDA Foreign Manufacturer Accreditation”, said the company management team. “This qualification opens up exciting new opportunities for us in Japan, allowing us to enter the market and offer high quality CDMO services. Looking ahead, we will continue to strengthen our global presence through professional R&D and production teams, robust production and quality management systems, and a commitment to meeting the needs of our international customers.”