Lupin Receives U.S. FDA Approval for Famotidine Injection, USP

MUMBAI, India and NAPLES, Fla, May 13, 2026 /PRNewswire/ -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials.

Famotidine Injection USP, 20 mg/2 mL (10 mg/mL) is bioequivalent to the reference listed drug (RLD), Pepcid® Injection, 10 mg/mL of Merck Sharp & Dohme Corp. It is indicated for intravenous use in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to the oral dosage forms for short term use in patients who are unable to take oral medication for the short term treatment of active duodenal ulcer, active benign gastric ulcer,  gastroesophageal reflux disease (GERD), maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer and treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas). This product would be manufactured at Lupin's Nagpur facility in India.

Famotidine Injection had estimated annual sales of USD 8.7 million in the U.S. (IQVIA MAT March 2026).

About Lupin

Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

To know more, visit www.lupin.com  or follow us on LinkedIn https://www.linkedin.com/company/lupin

*Safe Harbor Statement

Pepcid® is the registered trademark of Kenvue Inc.

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SOURCE Lupin Pharmaceuticals, Inc.