We are pleased to introduce our range of high-quality active pharmaceutical ingredients (APIs), now enhanced by the inclusion of Refarmed Chemicals, a recent addition to the DKSH Group. This merger allows us to better support your pharmaceutical production needs with a diverse portfolio of products and services.
Refarmed Chemicals, formerly known as Refarmed Research Pharmaceutique, was established in Switzerland in the 1970s. With over 40 years of experience, Refarmed Chemicals has built a reputation as a customer-focused distributor of APIs within the generic pharmaceutical industry. The company is fully integrated from APIs to finished dosage forms (FDFs) and boasts significant expertise in the clinical and biological sectors. In 2022, Refarmed Chemicals was acquired by DKSH Group, a global Market Expansion Services provider, further solidifying its industry position. This integration ensures a comprehensive approach to serving industry demands effectively.
Our Featured APIs
Trimebutine Maleate, a medication with antimuscarinic and weak mu opioid agonist effects, is used to treat irritable bowel syndrome and other gastrointestinal disorders. It comes with CEP, J-DMF, K-DMF, and WC certifications. The product is a white or almost white crystalline powder, identifiable by IR test. It is slightly soluble in water, soluble in acetonitrile, sparingly soluble in acetone, and slightly soluble in ethanol. Key properties include a melting point of about 133°C, clear and colorless solution appearance, loss on drying = 0.5%, and sulfated ash = 0.1%. Impurities are strictly controlled, with impurity E = 0.6%, unspecified impurity = 0.10%, total impurities = 0.15%, and individual impurity = 1.0%. Residual solvents include methanol = 0.3%, ethanol = 0.5%, toluene = 0.089%, and THF = 0.072%. The assay on a dried basis ranges from 99.0% to 101.5%.
Amiodarone Hydrochloride, an antiarrhythmic medication used for various types of cardiac dysrhythmias, comes with CEP, US-DMF, T-DMF, and WC certifications. It is a white or almost white fine crystalline powder, very slightly soluble in water, freely soluble in methylene chloride, soluble in methanol, and sparingly soluble in ethanol (96%). Identification methods include IR and chlorides tests, with a clear solution appearance and a pH range of 3.2 - 3.8. Key specifications include a loss on drying = 0.5%, sulfated ash = 0.1%, and iodides = 150 ppm. Impurities are controlled with individual impurities (A to G) each = 0.2%, impurity H = 0.02%, unspecified impurities = 0.10%, and total impurities = 0.5%. Residual solvents are limited to ethanol = 5000 ppm and toluene = 890 ppm. The assay on a dried basis ranges from 98.5% to 101.0%.
Mesalazine, also known as mesalamine or 5-aminosalicylic acid (5-ASA), treats inflammatory bowel diseases like ulcerative colitis and Crohn's disease. It is documented with CEP, US-DMF, J-DMF, WC, and EU-GMP certifications. This product appears as an almost white, light grey, or light pink powder or crystals. It is very slightly soluble in water and practically insoluble in ethanol (96%), but dissolves in dilute alkali hydroxides and hydrochloric acid. Identification is by IR test, and its solution appears clear. Key specifications include chlorides = 0.1%, sulphates = 200 ppm, loss on drying = 0.5%, and sulfated ash = 0.2%. Impurities are tightly controlled, with specified impurities (E, G, L, M, R, F, J, O, P) each = 0.5%, impurity H = 0.3%, impurities A and C = 200 ppm, impurity K = 10 ppm, unspecified impurities = 0.5%, and total impurities = 0.5%. Residual solvents include ethyl acetate 5000 ppm, methylene chloride 600 ppm, and ethanol 5000 ppm. The assay on a dried substance basis ranges from 98.5% to 101.5%.
Tioconazole, an antifungal medication of the imidazole class used to treat fungal and yeast infections, is documented with an EU-DMF and WC certification. It appears as a white or almost white crystalline powder, very slightly soluble in water, very soluble in methylene dichloride, and freely soluble in alcohol. Identification is by IR test, with key specifications including sulphated ash = 0.1% and water content = 0.5%. Impurities are controlled with impurities A, B, and C each = 0.3%, unspecified impurities = 0.10%, and total impurities = 1.0%. The assay on a dried basis ranges from 99.0% to 101.0%.
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