Active pharmaceutical ingredients
Make every effort to understand the needs of our customers, so that we can develop and provide innovative products for all sectors of society at an affordable cost. Uther has over 5000 products on sale and over 200 products under development. Our product portfolio caters to a wide range of treatment fields, such as cardiology, neurology, gastroenterology, pulmonary disease, diabetes, dermatology, ophthalmology, gynecology, etc.
Uther is one of the top producers of active pharmaceutical ingredients. Uther enables global innovators and generic drug companies to take the lead in bringing their finished products to the market by providing end-to-end support.
In order to help patients obtain affordable innovative drugs, Uther focuses on developing high-quality active pharmaceutical ingredients. With its expertise and capabilities in innovative research and development, Uther has developed NCE, generic API, steroids, and advanced intermediates for domestic, semi regulatory, and regulated markets.
Uther uses a variety of process combinations to produce various APIs, diversifying its product range and portfolio to respond to changes in consumer demand and meet their needs, from laboratory scale research to commercial production.
The API business is supported by three state-of-the-art research and development centers, with nearly 20 scientists continuously striving to synthesize cost-effective innovative processes.
These complex reaction capabilities include Grignard, Swern oxidation, Vilsmeir hack reaction, Friedel Crafts alkylation, asymmetric reaction and reduction, low-temperature, cyanide, enzymatic catalysis, chlorination, carboxylation, hydrogenation, and organic borane chemistry. They are regulated by laboratory scale, pilot scale, and commercial scale, and can also conduct spontaneous combustion and hazardous reagents at extremely low temperatures.
By maintaining cost leadership and competitiveness in various treatment fields, Uther API ensures the profitability and growth of the company's formulations, making it a global API supplier.
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Intellectual PropertyAn experienced intellectual property team works closely with the R&D department to develop innovative processes. The intellectual property team also provides extensive support for global generic drug companies to evaluate global patents.
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Regulatory AffairsUsher's internal regulatory team is experienced and understands the regulatory requirements of various markets.
The regulatory team has expertise in submitting DMFs and handling regulatory and customer defects, including most regulated markets in the United States, the European Union, Japan, and Brazil. The preparation of DMF meets the latest regulatory requirements.
Uther's regulatory team provides timely support to our valued clients worldwide in order to respond promptly to regulatory agencies.
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Manufacturing infrastructureAccording to cGMP requirements, Uther has two API and intermediate production bases. Our manufacturing facilities comply with regulatory requirements in the European Union, the United States, Japan, and various other markets. Most APIs are manufactured from basic starting materials between two sites, which allows us to fully control GMP and quality.