By: IPP Bureau
Last updated : May 15, 2026 7:04 am
Famotidine Injection USP is a generic version of Pepcid injection to be manufactured at its Nagpur facility for the U.S. market
Lupin Limited has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials, strengthening the company’s injectable portfolio in the U.S. market.
The approved product is bioequivalent to the reference listed drug, Pepcid Injection, 10 mg/mL of Merck Sharp & Dohme Corp..
Famotidine Injection is indicated for intravenous use in certain hospitalized patients with pathological hypersecretory conditions or intractable ulcers, and as an alternative to oral dosage forms for short-term treatment in patients unable to take oral medication.
The medication is used in the treatment of active duodenal ulcer, active benign gastric ulcer, gastroesophageal reflux disease (GERD), maintenance therapy for duodenal ulcer patients after healing of an active ulcer, and pathological hypersecretory conditions such as Zollinger-Ellison Syndrome and multiple endocrine adenomas.
The product will be manufactured at Nagpur, India, at Lupin’s manufacturing facility.
According to IQVIA MAT March 2026 data, Famotidine Injection recorded estimated annual sales of USD 8.7 million in the U.S. market.