Phyton Biotech has received Regulatory Approval from China’s NMPA for its plant cell fermentation-derived Paclitaxel Active Pharmaceutical Ingredient.
May 25th, 2021 – Phyton Biotech is pleased to announce approval from China’s regulatory body – National Medical Products Administration (NMPA) – for Phyton’s Drug Master File for paclitaxel active pharmaceutical ingredient produced via plant cell fermentation (PCF®).
This approval marks an important milestone for Phyton as it aims to expand its global sales of paclitaxel API with top pharmaceutical companies across the world. Phyton’s Paclitaxel API is the first plant cell fermentation-derived pharmaceutical product to receive regulatory approval in China.
Jackie Labbe, Phyton’s VP of Sales & Marketing explains, “Phyton is very pleased with this approval from the NMPA’s Centre for Drug Evaluation (CDE). We have been working tirelessly to expand our products globally, with China being the last key market to obtain approval. Phyton is recognized globally for its high-quality products and customers recognize Phyton as innovators of fermentation technology solutions for pharmaceutical products. The application of Phyton’s proprietary plant cell fermentation (PCF®) process to produce paclitaxel API, a widely used pharmaceutical ingredient in oncology formulations, demonstrates Phyton’s ability to consistently develop and commercialize high quality GMP products with minimal environmental impact and a sustainable footprint. In addition, Phyton’s ability to quickly respond to increasing market needs with its scalable process makes Phyton the obvious choice for customers concerned about security of supply.”
You can learn more about Phyton Biotech at www.phytonbiotech.com