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Improved Production Process From Evonik Industries

Thanks to an improved production process Evonik Industries can now offer the pharmaceutical active ingredient Lornithine L-aspartate (LOLA) in even higher quality and on more favorable terms.

“We want to share with our customers the cost advantages we’ve gained by increasing process efficiency,” says Dr.Thomas Hermann, Head of Evonik’s Rexim Product Line.

At the CPhI Worldwide trade show in Frankfurt, the specialty chemicals group announced an immediate price reduction of five to ten percent for LOLA.

The LOLA production process, based on fermentative production of L-ornithine and biocatalytic production of L-aspartic acid with subsequent purification to cGMP or food quality, has been improved at every stage. Crystals of particularly high purity can now be obtained. Due to this level of purity and higher stability compared to competitors’ products, LOLA from Evonik is well suited for use in all applications such as infusion solutions or tablets. The capability to produce granules from the product has been further improved which leads to even more easy processing.

Evonik offers its customers ready-to-use formulations for Lornithine L-aspartate tableting and will also, at the customer’s request, support the development of specific formulation solutions for this product.

LOLA is used as a therapeutic agent for the liver and supports the ammonia detoxification of the organism. A frequent area of application is in the treatment of hepatic encephalopathy. In response to increasing demand Evonik has expanded LOLA production capacity at its Ham site in France. “Complete backward integration of our production enables us to offer consistently high quality and supply security,” says Hermann.

Both of Evonik’s production sites for pharmaceutical amino acids, Ham and Wuming (China), are US FDA audited and regularly visited by European and Asian regulatory authorities. Both sites also meet HACCP, halal, and kosher standards. In addition to L-ornithine Laspartate in GMP quality, Evonik produces ornithine, ornithine HCl, and other ornithine salts for pharmaceutical, technical, and nutritional applications.

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