High-purity amino acids for pharmaceutical applications

For more than 60 years, Evonik is one of the world’s leading and most trusted suppliers of pharmaceutical amino acids. We are catering to the diverse needs of the pharmaceutical industry by supplying a broad portfolio of highly pure natural and non-natural pharmaceutical amino acids, salts and derivatives. Not only are we a major Western based supplier, but we also hold the highest quality certifications for amino acids used in pharmaceuticals, infant products, clinical applications, medical nutrition, food and many other areas. You can strengthen your supply security and streamline your complete supply chain thanks to our strong backward integration for many starting materials, which are manufactured at our large-scale fermentation facilities, and our other generic APIs, pharmaceutical ingredients and functional excipients. We also offer services for highly purified ingredients and assist in developing and scaling up your product formulations. If you aim to improve supply security and ensure consistent quality, Evonik is the global partner you are looking for. 

Contact us any time to learn more.

APPLICATIONS

Healthcare companies worldwide benefit from our purified amino acids, which help to enhance the safety, quality and reliability of medical nutrition products. In parenteral, enteral and infant nutrition, these amino acids provide an efficient intake of required nutrients. Our products enhance intravenous (IV) formulations for metabolic disorders, pre- and post-surgery diets and malnutrition treatments and can be added to high calorie drinks, meal replacements or formulas.

Evonik's amino acids, known for their top quality and purity, are attractive for pharmaceutical companies. They are ideal as starting materials for active pharmaceutical ingredients (API) or the synthesis of the final API and and specifically act as valuable precursor compounds for chiral substances in the field of pharmaceuticals. They can be used various forms, such as infusion solutions, tablet or granulated forms.

Our amino acids can also be added to medications to help protect, support or enhance stability and bioavailability of an API. As excipient, they can also aid the manufacturing process for a drug, help define a release profile, and improve patient acceptance. Excipients also contribute to product recognition and improve safety and function during storage and use. Evonik offers a wide range of amino acids that are proven to be effective excipients, meeting the pharmaceutical industry's diverse needs. 

Amino acids as excipients in oral formulations

  • Antioxidant/preservationSweetener
  • Formulation for amorphous drugs
  • Crystallization inhibitors
  • Stabilizers

Amino acids as excipients in parenteral formulations

  • Preservation of shelf life of proteins
  • Crystallization inhibitors
  • Bulking agent in lyophilized products

Amino acids are vital for making proteins and are essential in the cell culture media used to create biopharmaceuticals like therapeutic proteins and viral vectors. Our wide range of highly pure and non-animal-derived amino acids helps you to optimize the nutrient supply for cells, ensuring their optimal growth.

AMINO ACIDS, SALTS & DERIVATIVES OF EVONIK

CAS No.

DL-Methionine

59-51-8

Glycine

56-40-6

L-Alanine 

56-41-7

L-Arginine-L-Aspartate

7675-83-4

L-Asparagine hydrate

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 HCl

657-27-2

L-Lysine Hydrate 

39665-12-8

L-Lysine-L-Aspartate 

27348-32-9

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

All our amino acids are available in different grades.

Certifications

CERTIFICATIONS

AUDITS

  • 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 

Pharmaceutical amino acids to meet your requirements

Our pharmaceutical 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.

Get in touch!

Whether you are looking for a solution-provider to strengthen your pharmaceuticals business, an API manufacturer or are in search of novel excipients, we can help! Talk through your next project with us

LEARN MORE ABOUT OUR AMINO ACIDS