Bupivacaine

The iteration of local anesthetics has always been centered on the clinical needs of "longer analgesic duration and lower neurotoxicity". As a representative variety of long-acting amide local anesthetics, bupivacaine reversibly blocks the sodium ion channels of nerve fibers and inhibits the generation and conduction of nerve impulses, and its analgesic duration can reach 2-3 times that of lidocaine. It is mainly used clinically for surgical infiltration anesthesia, peripheral nerve block, epidural block and subarachnoid block, and can also be used in scenarios such as postoperative analgesia and labor analgesia. The applicable population covers surgical patients requiring medium and long-term analgesia and patients with chronic pain, and it is one of the basic drugs in the fields of clinical anesthesia and pain management.

The global bupivacaine market size is stable at around USD 1.2 billion, with a compound annual growth rate of approximately 3.2%. The growth drivers mainly come from the increase in the volume of day surgery, the expansion of postoperative analgesia demand and the expansion of primary anesthesia service coverage. The domestic market size exceeds RMB 1 billion, with generic drugs accounting for more than 90%. There are nearly 20 approved API manufacturers at present, among which enterprises in Jiangsu, Hubei and other regions are the main suppliers. Since 2021, multiple batches of inter-provincial centralized procurement have included bupivacaine injections in the catalog, with an average price reduction of 61% for winning bids, driving the demand for APIs to concentrate on leading manufacturers with stronger cost control capabilities.

The original developer of bupivacaine is Sterling Winthrop, with the original brand name Marcaine, and the core compound patent expired globally in 1983. At present, the mainstream clinical dosage forms include bupivacaine hydrochloride injection (5ml:25mg, 10ml:75mg) and bupivacaine hydrochloride liposome for injection (20ml:266mg). Common injections have been included in both the NMPA Chemical Reference Preparation Catalog and the FDA Reference Preparation Catalog. According to the domestic CDE API registration platform, there are currently 18 registration numbers for bupivacaine hydrochloride APIs, of which 12 are in the status of "A (already used in marketed preparations)", and there are another 3 registration numbers for imported APIs. The domestically approved bupivacaine preparation varieties have covered two categories: common injections and liposome injections. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO provides a full set of bupivacaine impurity reference standards, covering all categories such as synthesis process impurities, degradation impurities, enantiomers, etc. Most products are in stock, and orders placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulations such as the Chinese Pharmacopoeia and FDA, and can fully support the needs of API R&D, quality research and routine production testing.