Optimize the quality and purity of your active pharmaceutical ingredients

It has never been more important to optimize the quality, purity and supply security of your active pharmaceutical ingredients. Evonik has been a preferred supply partner to pharmaceutical companies seeking a reliable source of high-quality active pharmaceutical ingredients for more than 40 years. In addition to being one of the world’s largest contract manufacturers of active pharmaceutical ingredients, we provide customers worldwide with a broad portfolio of generic APIs including keto acids, controlled substances and those used with various essential medicines. In addition to the cGMP manufacturing of active pharmaceutical ingredients at our trusted sites in Europe and Asia, we also provide customers with a broad array of regulatory services to support their process validation and document submissions activities. All key certifications utilized with active pharmaceutical ingredients are also available including those required for GMP compliance, non-GMO products, kosher and halal certification, BSE / TSE and the use of non-animal origin materials.

Keto acids are used as active pharmaceutical ingredients to support the treatment and medication of patients with chronic kidney disease (CKD). Their role is to relieve the build-up of nitrogenous waste and other toxic substances inside the body. Evonik is not only the world’s largest manufacturer of keto acids but has also earned a strong track record of performance for the supply of these active pharmaceutical ingredients at the highest levels of quality and purity. Through our established manufacturing facilities for keto acids in Germany and China, we can support customers in the supply of all five keto acids and other amino acids used for CKD treatment drugs. In addition to these active pharmaceutical ingredients, we can supply other active pharmaceutical ingredients like the amino acids L-Lysine Acetate, L-Threonine and L-Tryptophane and EUDRAGIT® functional polymers as well as other formulation development and cGMP manufacturing services to help you complete the formulation. Feel free to contact us anytime for further information.

SOVIDINE® is Evonik’s brand of Chlorhexidine (CHD), which is used as an active pharmaceutical ingredient and for human and animal antiseptics. SOVIDINE® and its salts are effective against a broad variety of bacteria, enveloped viruses and fungi. Moreover, a number of studies have proven that CHD products such as SOVIDINE® act against antimicrobial-resistant bacteria – including wild types, mutant forms that typically occur in hospital environments, and superbugs such as MRSA that are resistant to traditional antibiotics. SOVIDINE® meets all the requirements of the latest version of the European Pharmacopoeia, as well as CEP, CosIng and BPR, and has been registered and approved for use with active pharmaceutical ingredients (APIs), biocides and cosmetics. SOVIDINE® can be utilized across a range of CHD pharmaceutical, medical device and cosmetic applications including wound dressings, as a surface and textile disinfectant, and with hygiene products such as mouth wash, lotions and soaps.

Benzodiazepines and controlled substance are active pharmaceutical ingredients that are used with psychoactive drugs to treat patients with anxiety, insomnia, seizures, insomnia, epilepsy and other medical conditions. Customers seeking to market drug products with benzodiazepines are required to gain permission from relevant regulatory authorities for the handling of these controlled substances. Evonik is one of the world’s leading suppliers of benzodiazepines, with decades of experience in the production and handling of these and other controlled substance active pharmaceutical ingredients. We have certifications in place for the supply of products including Lorazepam and Lormetazepam manufactured in Germany to a range of international regions including Europe, the U.S. and other countries.

L-Ornithine-L-Aspartate (LOLA) has been used as an active pharmaceutical ingredient for the treatment of liver diseases for many decades. Its ability to reduce ammonia levels also makes it ideal for use in nutraceutical applications that seek to help prevent liver disease as well as other sports nutrition products to encourage a faster post-workout recovery. Evonik’s brand of L-Ornithine-L-Aspartate utilizes a highly efficient purification process to ensure low methanol content and endotoxin levels. Due to its high purity, the active pharmaceutical ingredient can also generate superior stability. Furthermore, it has excellent uniform particle-size distribution as well as a crystalline structure compared to some other products on the market. While our L-Ornithine-L-Aspartate (LOLA) is available for supply as an active pharmaceutical ingredient, we also have extensive expertise in its development into formulations including effervescent or chewable tablets, rapid melt granules and tea bags.