Mumbai: Global pharma major Lupin Limited today announced the launch of Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials, after Lupin’s alliance partner Caplin Steriles Limited received an approval for its ANDA from the United States Food and Drug Administration (U.S. FDA).
Thiamine Hydrochloride Injection Usp, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials is therapeutically equivalent to the reference listed drug (RLD), Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100mg/mL) of Fresenius Kabi USA LLC.
Thiamine Hydrochloride Injection is effective in the treatment of Thiamine (Vitamin B1) deficiency or beriberi, a serious condition caused by prolonged lack of Vitamin B1.
Thiamine Hydrochloride Injection USP had estimated annual sales of USD 35 million in the U.S. (IQVIA MAT April 2023).
Mr. C. C. Paarthipan, Chairman of Caplin Point Laboratories Limited had commented “We’re glad to receive 3 back-to-back ANDA approvals recently, taking the tally to 16 approvals for Caplin Steriles and 4 more with partners. These recent approvals will not only help the company’s current targets, but also the future.”
Read also: USFDA nod to Caplin Steriles Thiamine Hydrochloride Injection
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 specializes 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 7.9% of its revenue in research and development in FY23. Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.
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