USFDA nod to Caplin Steriles Rocuronium Bromide Injection

Published On 2023-03-21 06:45 GMT   |   Update On 2023-03-21 06:59 GMT
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Mumbai: Pharma major Lupin Limited has announced that its alliance partner Caplin Steriles Limited has received final approval from the United States Food and Drug Administration (U.S.FDA) for its Abbreviated new Drug Application (ANDA) Rocuronium Bromide Injection, 10mg/mL in 5 mL and 10 mL Multi-Dose Vials.

The injection is a generic version of Zemuron Bromide Injection, 50 mg/5 mL and 100 mg/10 mL of Organon USA Inc.
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Rocuronium Bromide Injection (RLD: Zemuron) had an annual sale of approximately USD 53 million in the U.S. (IQVIA MAT December 2022).
On the same day, Caplin Steriles also received final approval from the USFDA for its ANDA Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials.

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 enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 8.7% of its revenue in research and development in FY22.

Read also: Lupin Digital Health declares results of digital therapeutics study with acute coronary syndrome patients

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