Caplin Steriles has received final USFDA approval to market Rocuronium Bromide Injection and Thiamine Hydrochloride Injection USP. Rocuronium Bromide Injection, the approved abbreviated new drug application (ANDA), is a generic version of Organon USA Inc.’s Zemuron Bromide Injection. Rocuronium Bromide injection is used in conjunction with general anaesthesia medications for rapid sequence intubation and routine tracheal intubation. This medication is also used to help relax muscles during surgery or mechanical ventilation.
Rocuronium Bromide Injection had an annual sales of approximately $53 million in the United States, according to IQVIA MAT December 2022 data. Furthermore, the US drug regulator approved ANDA for Thiamine Hydrochloride Injection USP, which is therapeutically equivalent to Fresenius Kabi USA LLC’s reference listed drug (RLD), Thiamine Hydrochloride Injection USP. Thiamine Hydrochloride injection is used to treat thiamine deficiency or beriberi, whether the symptoms are dry (related to the nervous system) or wet (related to the cardiovascular system).
Thiamine Hydrochloride Injection USP had an annual sales of approximately $36 million in the United States, according to IQVIA MAT December 2022 data. Lupin is a transnational pharmaceutical company based in Mumbai, India that focuses on innovation. The Company develops and commercialises a diverse range of branded and generic formulations, biotechnology products, and APIs in over 100 markets worldwide, including the United States, India, South Africa, and Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.