Lupin Limited has received approval from the U.S. Food and Drug Administration (FDA) for its Famotidine Injection, USP. The product, available in 20 mg/2 mL (10 mg/mL) single-dose vials, is bioequivalent to the reference drug Pepcid. Indicated for the treatment of various gastrointestinal conditions, this drug will be manufactured at Lupin’s facility in Nagpur, India. The product represents a significant addition to the company’s portfolio with estimated annual U.S. sales of USD 8.7 million.
Market Expansion in the U.S.
Lupin Limited has reached a new regulatory milestone with the U.S. FDA approval for its Famotidine Injection, USP. This approval allows the company to market its bioequivalent version of the reference listed drug, Pepcid Injection, in the United States. The injectable form serves as a crucial clinical alternative for hospitalized patients who require treatment for conditions such as active duodenal ulcers, gastric ulcers, and gastroesophageal reflux disease (GERD).
Strategic Manufacturing and Impact
The approved injectable treatment will be produced at the company’s manufacturing facility located in Nagpur, India. According to recent market data (IQVIA MAT March 2026), the product segment has estimated annual sales of USD 8.7 million in the U.S. market. This development strengthens Lupin’s presence in the complex injectables segment and highlights its ongoing commitment to providing diverse therapeutic solutions across its global markets.
Source: BSE
