Lupin's partner receives USFDA approval for 2 drugs

The drug major on Monday announced that its alliance partner, Caplin Steriles received final approval from the United States Food and Drug Administration (USFDA) to market Rocuronium Bromide Injection and Thiamine Hydrochloride Injection USP.

The approved abbreviated new drug application (ANDA), Rocuronium Bromide Injection is a generic version of Zemuron Bromide Injection of Organon USA Inc.

Rocuronium Bromide injection is used with general anesthesia medicines for rapid sequence intubation and routine tracheal intubation. This medicine is also used to help relax the muscles during surgery or mechanical ventilation.

According to IQVIA MAT December 2022 data, Rocuronium Bromide Injection had an annual sale of approximately $53 million in the U.S.

 

Further, the US drug regulator also approved ANDA for Thiamine Hydrochloride Injection USP, which is therapeutically equivalent to the reference listed drug (RLD), Thiamine Hydrochloride Injection USP of Fresenius Kabi USA LLC.

Thiamine Hydrochloride injection is used for the treatment of thiamine deficiency or beriberi whether of the dry (major symptoms related to the nervous system) or wet (major symptoms related to the cardiovascular system) variety.

According to IQVIA MAT December 2022 data, Thiamine Hydrochloride Injection USP had an annual sale of approximately $36 million in the U.S.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The company reported 71.9% drop in net profit to Rs 153.5 crore despite of 3.8% rise in net sales to Rs to Rs 4,244.6 crore in Q3 FY23 over Q3 FY22.

Shares of Lupin rose 0.46% to Rs 649.15 on the BSE.

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