Lupin Limited has informed the Exchange regarding a press release dated May 13, 2026, titled "Lupin Receives U.S. FDA Approval for Famotidine Injection, USP".
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Lupin Limited has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Famotidine Injection USP (20 mg/2 mL single-dose vials). The product is bioequivalent to Merck Sharp & Dohme's Pepcid® Injection and will be manufactured at Lupin's Nagpur facility in India. Famotidine Injection is used intravenously for hospitalized patients with hypersecretory conditions, ulcers, GERD, and Zollinger-Ellison Syndrome. The drug had estimated annual U.S. sales of USD 8.7 million as of March 2026 (IQVIA data). This marks another generic drug approval for Lupin in the U.S. market.
This FDA approval strengthens Lupin's U.S. generic portfolio and provides a new revenue stream from a niche injectable product. While the USD 8.7 million market is relatively modest, consistent FDA approvals support long-term growth and investor confidence in the company's pipeline execution.