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Shijiazhuang Sihua Pharmaceutical Obtains Drug Production Registration Approval for Ropivacaine Hydrochloride Injection in Polypropylene Ampoules

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Honors Announcement

发布时间：2020-04-01

【概要描述】 Recently, Shijiazhuang Sihua Pharmaceutical Co., Ltd. obtained from the National Medical Products Administration approval for the production registration of ropivacaine hydrochloride injection (10 mL: 100 mg) in polypropylene ampoules. This product was submitted as a Type 4 generic and, upon approval for manufacture, will be deemed to have passed the consistency evaluation.

Shijiazhuang Sihua Pharmaceutical Obtains Drug Production Registration Approval for Ropivacaine Hydrochloride Injection in Polypropylene Ampoules

Recently, Shijiazhuang Sihua Pharmaceutical Co., Ltd. obtained the drug registration approval from the National Medical Products Administration for ropivacaine hydrochloride injection (10 mL: 100 mg) in polypropylene ampoule packaging. This product was submitted as a Type 4 generic and, upon approval for manufacture, will be deemed to have passed the bioequivalence evaluation.

Ropivacaine is a long-acting, pure S-enantiomer amide local anesthetic that exerts both anesthetic and analgesic effects. At higher doses, it produces surgical anesthesia; at lower doses, it induces sensory blockade (analgesia) accompanied only by limited, non-progressive motor nerve block. Clinically, it is primarily used for surgical anesthesia and the management of acute pain.

Shijiazhuang Sihua Pharmaceutical’s ropivacaine hydrochloride injection (10 mL: 100 mg in polypropylene ampoules) has become the first product to pass national review and approval as being bioequivalent to the originator drug in terms of quality and efficacy, receiving a manufacturing license under Category 4 of the new classification for chemical drugs. It is also the first domestically produced formulation packaged in ampoules.

According to data from MeneNet, the ropivacaine injection products currently marketed in the Chinese domestic market include ropivacaine hydrochloride injection, ropivacaine hydrochloride for injection, ropivacaine mesylate injection, and ropivacaine mesylate for injection. In 2018, total sales at the end-user level—comprising urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics (collectively referred to as China’s public medical institutions)—amounted to RMB 1.022 billion, representing a year-on-year increase of 9.68%. Among these, 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: RMB 10,000)