Amino acids are often referred to as the building blocks of life. As a core constituent of proteins, amino acids play a vital role in a range of biochemical processes that govern our metabolism and health.
When these amino acids are manufactured and purified to the highest quality standards, they become an essential ingredient in countless products used across areas including medical nutrition, nutraceuticals, APIs, excipients, cell culture and many more applications.
For more than 60 years, Evonik has been one of the world’s leading and most trusted suppliers of pharmaceutical amino acids. In the production of our REXIM® amino acids, we combine large‑scale fermentation, enzymatic bioconversion, and chemical synthesis with advanced purification technologies at two reliable manufacturing sites in Europe and Asia, ensuring high‑purity, pharma‑grade consistency and offering value‑added services for amino acids, salts, and derivatives.
Our amino acids are available in different grades and being used amongst different application areas:
Our amino acids, salts & derivates at a glance
Please note: All of our products are available in different grades.
| Amino acid | CAS number | |
|---|---|---|
| DL-Methionine | 59-51-8 | |
| Glycine | 56-40-6 | |
| L-Alanine | 56-41-7 | |
| L-Asparagine monohydrate | 5794-13-8 | |
| L-Aspartic acid | 56-84-8 | |
| L-Glutamic acid | 56-86-0 | |
| L-Leucine | 61-90-5 | |
| L-Lysine Acetate | 57-282-49-2 | |
| L-Lysine hydrochloride | 657-27-2 | |
| L-Lysine monohydrate | 39665-12-8 | |
| L-Methionine | 63-68-3 | |
| L-Ornithine-L-Aspartate | 3230-94-2 | |
| L-Phenylalanine | 63-91-2 | |
| L-Proline | 147-85-3 | |
| L-Serine | 56-45-1 | |
| L-Threonine | 72-19-5 | |
| L-Valine | 72-18-4 | |
| N-Ac-DL-Methionine | 1115-47-5 |
End-to-end control ensures premium quality and supply reliability
Being backward-integrated for several amino acids, we are able to perform every step of the manufacturing process in-house – from the production of basic amino acids, to chemical derivatization and GMP-grade purification. The same goes for our supply chain. Having full control over every input into our processes allows us to deliver high-quality products consistently and ensure reliable security of supply. It also means we offer a level of accountability that is rare in the industry.
Amino acids to meet your requirements
Our amino acids fulfill your safety, quality and regulatory requirements. Evonik holds the necessary certifications to satisfy strict quality and regulatory standards for the manufacture of highly pure pharmaceutical amino acids and derivatives. Our manufacturing sites in France, Slovakia and China have a strong regulatory record with the FDA and other notified bodies. We are also in compliance with 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).
In addition, our quality systems adhere to HACCP, Halal and Kosher requirements. With every batch we provide Certificates of Analysis. Our 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.
- GMP compliance (ICH Q7)
- ISO certification 9001, 14001, 50001, FSSC 22000
- Hazard Analysis and Critical Control Point Concept (HACCP) compliance
- High-purity chemical grade and controlled levels of microorganisms and endotoxins
- No chlorinated solvents, preservatives, antioxidants, mycotoxins, aflatoxins, pesticides, hormones, dioxins or cytotoxic compounds
- Kosher and halal certifications
- Statement on allergens, residual solvents and Bovine Spongiform
- Encephalopathy(BSE)/Transmissible Bovine Encephalopathy (TSE) available
- United State Pharmacopoeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP) and Food Chemical Code (FCC) monograph compliant
- Non-animal origin
- SEDEX* audited plants – when applicable
- Customer agencies (FDA, PMDA and ANSM** as example compliance)
- REACH registration
- Expertise in registration processes worldwide
- Expertise in the specifics of regional regulations
- Proactive implementation of new regulatory requirements
- Creation and maintenance of Drug Master Files (DMF)
- Creation and maintenance of Certificates of Sustainability (CEP)
- Consultancy for regulatory issues
- Services for regulatory affairs
Leveraging our formulation and application services for amino acids
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 to give you a clear competitive advantage in your end market. In addition, we can provide our own formulations for certain products and applications. Our development services cover all steps from early feasibility studies to large-scale production transfer, including clinical supply manufacturing and scale-up support. To support your quality, development and regulatory submission processes, we provide comprehensive data packages as a service to our customers.
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