Northwest Biotech Pioneer Launches First Commercial Batch Of Bio-Synthesized Ursodeoxycholic Acid API

——Dual-Enzyme Process Redefines Sustainable Pharmaceutical Manufacturing

A leading biotechnology enterprise in Northwest China has commenced commercial production of Ursodeoxycholic Acid (UDCA) active pharmaceutical ingredient (API), marking the region's inaugural transition from bulk intermediates to high-value pharmaceutical-grade materials. The first 350kg batch, manufactured under China NMPA certification, was successfully packaged on February 21st at the company's fully automated purification facility.

Next-Gen Biocatalytic Technology

The breakthrough leverages a proprietary dual-enzyme fermentation system developed over five years of R&D, achieving:

68% reduction in energy consumption vs traditional chemical synthesis

99.2% chromatographic purity meeting EP/USP standards

Closed-loop production with 95% solvent recovery rate

"Unlike conventional UDCA manufacturing, our bio-conversion process operates under ambient temperatures with zero heavy metal catalysts," explained the company's technical director. "The continuous flow purification system integrates simulated moving bed chromatography with AI-driven crystallization controls, enabling annual capacity of 120 metric tons."

Strategic Industrial Transformation

This milestone completes the manufacturer's three-phase evolution:

2018-2020: Transition from chemical intermediates to pharmaceutical precursors

2021-2023: Establishment of GMP-compliant biocatalytic platforms

2024+: Commercialization of novel enzymatic APIs

The production line's real-time monitoring systems track 18 critical process parameters (CPPs), including particle morphology and residual solvents, ensuring batch-to-batch consistency.

Market Implications

As the first NMPA-certified UDCA API producer in its region, the company now supplies:

40% purer gallstone dissolution agents than industry benchmarks

Pharmaceutical-grade materials with 30% shorter lead times

Customizable particle size distributions (10-150μm)

Industry analysts project this innovation could capture 15-20% of the global UDCA API market within three years, particularly benefiting chronic hepatobiliary therapy formulations.