Rely upon our trusted Western-centered manufacturing network plus value-adding services for pharmaceutical amino acids and high purity raw ingredients
Evonik is one of the world’s leading and most trusted suppliers of pharmaceutical amino acids. For more than 40 years, customers have been leveraging our broad portfolio of highly pure natural and non-natural pharmaceutical amino acids, salts and derivatives. In addition to us being the industry’s largest Western-based supplier, we are certified to the highest quality standards for amino acids used across pharmaceutical, infant, clinical and medical nutrition, and food applications. Our strong backward integration for starting materials manufactured at our large-scale fermentation facilities, as well as other generic APIs, pharmaceutical ingredients and functional excipients, can help to strengthen supply security and streamline your complete supply chain. We also provide a range of services for highly purified ingredients, as well as the development and scale-up of your own product formulations. If you are seeking to improve supply security and optimize quality consistency, Evonik has the size as well as growth, strength and global scale to serve as a preferred global partner. Contact us anytime for individual information.
Our pharmaceutical amino acids can meet your stringent quality and regulatory requirements
Evonik has the required certifications to meet stringent quality and regulatory standards for the production of highly pure pharmaceutical amino acids and derivatives. Our manufacturing facilities in France, Slovakia and China have a strong regulatory record with the FDA and other notified bodies. We are also in compliance for all monographs across key global markets such as the U.S., Europe and Japan, and certified to ICH/Q7a (Good Manufacturing Practice of APIs), ISO 22000, and the stringent infant medical nutrition standard Food for Special Medical Purpose (FSMP). Furthermore, our quality systems conform to HACCP, Halal and Kosher. Certificates of Analysis can be provided with all batches. This unrivalled history of excellence across fermentation, bioconversion, synthetic-based manufacturing processes and purification makes us a reliable choice for the consistent supply of high-quality pharmaceutical amino acids.
The REXIM® portfolio of pharmaceutical amino acids stands for dependability and flexibility
The REXIM® portfolio of highly purified, animal origin free pharmaceutical amino acids, derivatives and peptides has earned the industry’s finest reputation for quality and dependability over many decades of use. The portfolio includes more than 30 ready-to-ship ingredients that play a central role in metabolism and health. Essential amino acids include L-Leucine, L-Valine, L-Lysine, L-Methionine, L-Phenylalanine, L-Threonine and L-Tryptophane. Non-essential amino acids include L-Alanine, L-Aspartic acid, L-Glutamic acid, L-Serine, L-Asparagine, Glycine and L-Proline. A range of homogeneous, powder-based premixes can also be provided to increase application versatility and streamline production. In addition to the cGMP manufacturing of pharmaceutical amino acids for parenteral nutrition and medical nutrition, we also have extensive expertise in their use as excipients with a range of oral and parenteral formulations.
A leading supplier of L-Ornithine-L-Aspartate for medicinal and nutraceutical applications
L-Ornithine-L-Aspartate is a highly innovative amino-acid salt that combines enhanced levels of purity and stability with consistent quality. It can be supplied as a detoxifying agent for the medicinal treatment of liver disease, and as a nutraceutical grade. In addition to its standard formulation, Evonik can provide it in a range of standard or custom forms including effervescent and chewable tablets, as well as effervescent, fast-melt and generic granules. Additional Ornithine-derivatives, APIs, supplements or nutraceutical grades can also be supplied upon request.
Beyond pharmaceutical amino acids: Leverage our range of formulation and application services
Evonik has the technical expertise, operational capabilities and global network of laboratories to provide you with an extensive range of value-adding services relating to the use of pharmaceutical amino acids, including ingredient formulation, special packaging and regulatory registration support. We can help you improve your formulations with the goal of giving you a clear competitive edge in your final market. Moreover, we can provide our own formulations for certain products and applications. Our development services include all steps from early feasibility studies to large-scale production transfer, including clinical supply manufacturing and scale-up support. To support your quality and development processes, as well as your regulatory submission processes, we provide comprehensive data packages as services to our customers.
PHARMACEUTICAL GRADE AMINO ACIDS PORTFOLIO
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