RTU provides broad-ranging services from business cooperation in research and development stage, like production of investigational drug products for clinical studies and data collection for IND (Investigational New Drug Application) / NDA (New Drug Application), to commercial production under contract manufacturing agreement to satisfy all of our customers’ needs. Our services are offered in Japan as well as on a global scale, enabling us to assist companies in the U.S., Europe and other regions in the world with their R&D and manufacturing activities.
R-Tech Ueno can offer high-quality R&D assistance services to our customs. Our services include, but are not limited to, development of synthetic methods and characterization studies of new compounds, formulation studies including improvement to obtain excellent stability and absorption to the body, quality tests and stability tests of drug substances and drug products. We also welcome inquiries about a variety of technical tasks other than those listed below.
Development of synthetic methods and Contract manufacturing of drug substances
RTU can provide our customers with research services for development of effective synthetic methods and scale-up studies for industrial production of drug substance (active ingredient). In addition, we can manufacture drug substances for GLP studies and investigational products for clinical studies. We have years of experience in the production and supply of investigational drug substances used for clinical trials overseas. We are also capable of preparing the CMC documents that are necessary for investigational new drug application (IND) and new drug application (NDA).
Characterization study (Evaluation of physico-chemical properties of Drug substance
R-Tech Ueno can perform collecting data, such as physico-chemical properties of the drug substance that is essential to prepare application dossier. We are capable of preparing technical documents to meet requirements form the health authorities in the ICH harmonized countries. We also have the expertise in instrumental analyses. We can measure and provide high quality data of NMR, LCMS, thermal analysis and powder x-ray diffraction, and other analyses.
Development of drug product (Formulation studies)
We can handle every step involving pre-formulation research to match the physical characteristics of each compound and formulation studies to determine dosage form. Our professionals can make drugs from compounds that are difficult to dissolve, make drugs easier to dissolve and absorb, perform drug delivery system (DDS) studies to improve bioavailability and handle other tasks. We can make formulation using the excipients composition that comply with all applicable regulations. R-Tech Ueno have a proven record of reliability in formulation studies for injections, eye drops, liquid drugs, solid formulations and ointments.
Quality testis and stability evaluations for investigational drugs and test articles for safety studies
R-Tech Ueno can perform quality testing and stability evaluation that comply with cGMP, investigational drug GMP and all other standards for investigational drugs as well as for test articles used in safety studies. We are also capable of developing a variety of analytical methods (testing methods). In particular, we can use our extensive experience in the analysis of trace amounts of components, which are difficult to analyze, to offer customers ideas concerning a broad range of analytical procedures.
Release tests (specification tests) and stability tests for drugs and establishment of drug specification for application
We can conduct quality tests in accordance with ICH and many other guidelines, and prepare documents for application incorporating accurate data. In addition, we can provide suggestions for the establishment of drug specification for application according to impurity profile.
Documentation for drug application
We can assist customers in the preparation of documents required for drug application in compliance with the regulations of the ICH harmonized countries.
Provision of documents and other responses to regulatory authorities
R-Tech Ueno can assist with the preparation of materials and other tasks for document-based studies and other investigations required by regulatory authorities. This service includes documents used for quality, stability and other types of tests.
The manufacture of pharmaceuticals is directly linked to protection of human life. We can perform manufacturing of pharmaceuticals on the highly quality assured. The R-Tech Ueno factory in the city Sanda in Hyogo prefecture has passed GMP inspections by the Japanese Ministry of Health, Labour and Welfare, the U.S. Food and Drug Administration and EU regulatory authorities. All of these agencies have approved this factory for the production of pharmaceuticals. Supported by these experiences in manufacturing of pharmaceuticals, we can manufacture high quality products that fulfill all GMP requirements form health authorities, through our high-level manufacturing control, quality control and quality assurance.
Eye drops
R-Tech Ueno has been manufacturing eye drops for sale in Japan for more than 15 years. We have undergone inspections by Japanese and U.S. regulatory authorities to confirm compliance with GMP. Our advanced quality assurance system means that companies can rely on us to supply eye drops that meet the highest standards.
Liquid drugs
We Manufacturing and quality control expertise gained from producing eye drops allows us to perform the contract manufacturing of a variety of liquid drugs.
Liquid-filled hard capsules
R-Tech Ueno has started a contract manufacturing service for liquid-filled hard capsules. Approximately 40% of all compounds in various stages of pharmaceutical development have poor solubility in water. Transforming these compounds into a form that can be used in clinical trials is extremely difficult. The greatest advantage of liquid-filled hard capsules is the ability to make drugs with compounds that are oil soluble or difficult to dissolve in water. Furthermore, these capsules can enhance solubility and absorption of the compound. This makes it possible to develop drugs that permit the use of drug delivery systems that have better bio availability.
| The Sanda factory of R-Tech Ueno is capable of performing processes ranging from the manufacture of drug substances to the manufacture and packaging of final dosage-form products. |  |
（cGMP-compliant facilities）
In Sanda, Hyogo, we have a drug substance plant that complies with the GMP requirements of Japan, the United States and Europe Currently, we are producing the active ingredients of Rescula® Eye Drops and Amitiza® on a commercial scale. The plant is also capable of manufacturing investigational drug substances.
Features of production facilities and technologies
The drug substance plant can be utilized for the organic synthesis process in the range from small to large commercial production scale. The plant is equipped with large column chromatography systems that realize industrial purification of oily compounds that are impossible or very difficult to refine by conventional methods. Furthermore, through our many years of experience in the manufacture of prostaglandins, we have developed unique technologies for handling of unstable compounds and highly potent compounds
（cGMP-compliant facilities）
R-Tech Ueno has production facilities that have passed GMP inspections by Japanese and U.S. regulatory authorities. We use these facilities to manufacture Rescula® Eye Drops on a commercial scale.
Production facilities
Equipment includes a liquid mixing tank, eye drop and liquid drug filling equipment, automatic inspection machine, shrink labeler, tack labeler, cartoner and other facilities. We also have a liquid filling and sealing system for capsules.
Processes that meet the requirements of contract manufacturing
For both investigational drugs and pharmaceuticals, we can perform liquid solution preparation, sterilization, filling and sealing, labeling and packaging, and other processes.
（cGMP-compliant）
R-Tech Ueno can perform highly sophisticated quality evaluations and tests by using systems that have been certified by GMP inspections by Japanese, U.S. and European regulatory authorities. We perform standard conformity and stability tests that comply with ICH and many other guidelines. Our quality is backed by experience gained from providing contract manufacturing services for drug substances and pharmaceuticals as well as from performing tests for other companies.
FDA (Food and Drug Administration)
A US governmental organization in charge of marketing approval of food, drugs, cosmetics, medical device, etc. and control of illegal products, etc.
cGMP (Current Good Manufacturing Practice)
Standard for manufacturing control and quality control of pharmaceuticals.
CMC (Chemistry, Manufacturing and Control)
It originally means information regarding chemistry, manufacturing and quality control in application dossier, but it also refers to general operations related to such technical information in the broad sense. For example, it refers to development of formulation, production method, testing method and establishment of quality specification, etc.
