Wuhan RS Pharmaceuticals Co., Ltd
Wuhan RS Pharmaceuticals Co., Ltd was founded on April 13, 2009, is a pharmaceutical API production base in accordance with the requirements of cGMP standards, located in the development zone - Hubei Gedian Economic and Technological Development Zone, with an area of 172 acres in the first phase and 200 acres in the second phase, a total of 372 acres. The company has introduced a large number of domestic and foreign high-quality personnel, while gradually cultivating its own R & D strength, building a full set of R & D system from small test, pilot to production. The company adopts domestic and foreign high-quality production facilities and equipment, international first-class QC laboratory inspection instruments, imported pure water and compressed air equipment, supporting a high degree of automation of sewage treatment and environmental monitoring facilities, based on ISO and OSHA's EHS requirements, the U.S. FDA and EU cGMP standards of the export-oriented high-end pharmaceutical raw materials production base, and will soon be subject to the FDA and EU cGMP official inspection. We are about to receive cGMP official inspection from FDA and EU. At present, we have successfully exported to the United States, Europe, India and other international markets.
The company has completed a number of API innovative technology research in cardiovascular, cerebrovascular, digestive, antifungal, antiviral and other therapeutic areas, and is striving to realize 20-24 new generic API projects in the next 3-5 years. In addition to meeting the raw material needs of Qirui Pharmaceuticals, a subsidiary of Qirui Group, the company has declared the U.S. FDA DMF, the European EDMF and the COS in accordance with the requirements of the international regulations and is heading for the international market. We are going to the international market.
Start trial production; The production license was obtained in October
Passed the new GMP certification of atorvastatin calcium and Fasudil mesylate
Passed the new version of Solvatone GMP certification
The 105 workshop with a high degree of automation was built
Voriconazole and sulfobutylbetacyclodextrin were declared
The QR0005DS and QR002DS projects were declared at the end of the year
Voriconazole project registration number changed to A, and passed GMP dynamic verification in July
GMP dynamic verification of voriconazole production line
Sulfobutylbetacyclodextrin sodium project registration number to A
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