Caplin, a partner in the Lupin alliance, has received FDA approval for its thiamine hydrochloride injection USP

The leading pharmaceutical company in the world, Lupin Limited (Lupin), today reported that its alliance partner Caplin Steriles Limited (Caplin) has received final FDA approval for its Abbreviated New Drug Application (ANDA) for Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials, which aims to market a medication that is therapeutically equivalent to the reference listed drug (RLD), Thiamine Hydrochloride Injection US

injection of thiamine hydrochloride In the United States, USP sold over USD 36 million worth of goods each year (IQVIA MAT for the 12-month period ending December2022).

More About Caplin Steriles

A firm focusing on R&D, Caplin Steriles develops and produces high-quality injectables and ophthalmic solutions for regulated markets. The business has a strong history of quality compliance, capacity for development, and dependable partnerships. Caplin keeps track of a hybrid mix of internal developments, filings, and CDMO agreements with outside businesses. Injectables in Vials, Lyophilized Vials, Pre-Mixed Bags, Prefilled Syringes, Long Acting Suspension and Emulsion Injectables, and Ophthalmics are just a few of the latest technologies and capabilities that the company is continually investing in. A division of the rapidly expanding pharmaceutical company Caplin Point Laboratories Ltd. is Caplin Steriles.

More About Lupin

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. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 8.7% of its revenue in research and development in FY22.

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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