Yamasa has manufactured nucleic acid related compounds over 60 years. Nucleic acid related compounds have been used in broad fields. Yamasa offers customers a partnership for API process development and API manufacturing using its unique experiences and technologies of nucleic acid related compounds. Yamasa is expanding its presence globally especially in the USA, Europe and Asia.
Manufacture and sale of nucleic acid related APIs and intermediates
Yamasa specializes in the manufacturing of small molecular nucleic acid related APIs and intermediates from milligrams up to thousands of kilograms. Yamasa offers APIs and intermediates listed in our product list. In addition, Yamasa offers your requested products with process development.
Yamasa has been establishing high quality standard with our manufacturing of APIs over 45 years. Yamasa's cGMP plants in Choshi, Japan have been audited by PMDA, FDA and MFDS (former KFDA).
Custom synthesis at laboratory
Yamasa synthesize candidate compounds for new drugs required from discovery to early clinical stage at laboratory. Utilizing our experience of drug discovery research for anticancer drugs and antivirus drugs of nucleic acid related compounds, Yamasa synthesizes various nucleic acid related compounds whose sugar, nucleobase or phosphate is modified.
Process development and contract manufacturing
Yamasa provides contract manufacturing using processes proposed by customers as well as manufacturing with new processes developed by Yamasa. Yamasa has wide variety of equipment, listed in the "Facility" page.
Yamasa can support you by process development. Yamasa's unique expertise and technologies of nucleic acid related compounds help your development proceed rapidly in cost-effective way. Yamasa conducts process research, process development, process optimization and scale up.
Yamasa is strong at:
- Nucleic acid related compounds
- phosphorylated compounds
- hydrophilic compounds
Preparation of regulatory applications and development of analytical methods
Yamasa supports your business by preparation of regulatory applications and development of analytical methods.
Preparation of regulatory applications
Yamasa provides regulatory support during all stages. Yamasa has a broad range of registration and maintenance experience in Japan, USA, EU and Asia such as;
- Drug master file (DMF)
- CMC quality module documentation in CTD format for IND and NDA, and MAA
- Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP)
Development of analytical method
Yamasa provides analytical support. With state-of-art instrument, our experienced analytical chemists can develop suitable analytical method for nucleic acid related compounds.
Manufacture and sale of generic APIs
Yamasa manufactures generic APIs with high quality in Japan. Yamasa files Drug Master Files (DMF) or Certificate of Suitability to the Monographs of the European Pharmacopoeia (CEP) for APIs.
Manufacture and sale of food ingredients
Yamasa is a world leading supplier of 5’-nucleotides: 5’-AMP, 5’-CMP, 5’-GMP, 5’-IMP, and 5’-UMP. Yamasa manufactures high quality 5’-nucleotides for food additives under ISO 9001 quality management system in Japan. Nowadays 5’-nucleotides are globally used as key ingredients for infant formula. We can supply all 5’-nucleotides because of the RNA degradation method. Halal certificate and kosher certificate are available.
Manufacture and sale of fine chemicals
Yamasa manufactures nucleic acid related compounds used for cosmetic ingredients and other industrial products.
Global sale, procurement and regulatory arrangement
Yamasa expands business operations worldwide. Each business is attributed to a salesperson who is professional of overseas business, market and act and law.
Yamasa supports your procurement by utilizing our experience in overseas business.
Yamasa has experience of inspections by foreign regulatory authorities. Yamasa's experts in regulatory affairs maintain conformance to current good manufacturing practice requirements (cGMP).
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