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ABOUT USAffiliated to SSY Group Limited, Hebei Guangxiang Technology Co., Ltd., is a high-tech enterprise specializing in drug research and technology development.
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CONTACTWe will continue to strengthen innovation-driven development, vigorously promote the integration of production and research, constantly improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs.
Shijiazhuang No.4 Pharmaceutical has obtained the drug registration approval for ropivacaine hydrochloride injection packaged in polypropylene ampoules.
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Time：2020-04-01
Recently, Shijiazhuang No.4 Pharmaceutical Co., Ltd. obtained the drug registration approval from the National Medical Products Administration for ropivacaine hydrochloride injection (10 ml: 100 mg) packaged in polypropylene ampoules. This product was filed as a generic Class 4 application and, upon approval for production, will be deemed to have passed the consistency evaluation.
Recently, Shijiazhuang No.4 Pharmaceutical Co., Ltd. obtained the drug registration approval from the National Medical Products Administration for ropivacaine hydrochloride injection (10 ml: 100 mg) packaged in polypropylene ampoules. This product was submitted as a generic Class 4 application and, upon approval for production, will be deemed to have passed the consistency evaluation.
Ropivacaine is a pure levorotatory, long-acting amide local anesthetic with both anesthetic and analgesic effects. At high doses, it can induce surgical anesthesia; at lower doses, it produces sensory blockade (analgesia) accompanied only by localized, non-progressive motor nerve block. Clinically, it is primarily used for surgical anesthesia and the management of acute pain.
The ropivacaine hydrochloride injection (10 ml: 100 mg, packaged in polypropylene ampoules) submitted by Shijiazhuang No.4 Pharmaceutical is the first product to have passed the national review and approval process, demonstrating consistency with the original reference drug in terms of quality and efficacy. It has been granted a production license under the new classification of chemical drugs—Category 4—and is also the first domestically produced product packaged in ampoule containers.
According to information from MeneNet, the ropivacaine injection products currently available on the Chinese market include ropivacaine hydrochloride injection, ropivacaine hydrochloride for injection, ropivacaine mesylate injection, and ropivacaine mesylate for injection. In 2018, the total sales volume at the terminal level—comprising China’s urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics (collectively referred to as China’s public medical institutions)—reached 1.022 billion yuan, representing a year-on-year increase of 9.68%. Among these products, ropivacaine hydrochloride injection accounted for more than 70% of the market share.
Sales of Ropivacaine Injection at the Terminal Level in China’s Public Medical Institutions, 2013–2018 (Unit: 10,000 yuan)
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