Lupin

Indian pharmaceutical major Lupin Ltd. has announced the launch of a generic version of Ravicti (glycerol phenylbutyrate) oral liquid in the United States for the treatment of urea cycle disorders (UCDs), a rare genetic condition affecting nitrogen elimination. The product, launched after securing approval from the U.S. Food and Drug Administration (FDA), represents another milestone in Lupin’s strategy to strengthen its presence in the U.S. generics and specialty care markets.

Pharmaceutical major Lupin has secured approval from the U.S. Food and Drug Administration (USFDA) for the launch of a generic version of a widely prescribed cancer treatment. The regulatory clearance marks a significant milestone for the company as it strengthens its foothold in the U.S. generics market, one of the most competitive healthcare landscapes globally. The new approval is expected to broaden access to affordable cancer therapy while contributing to Lupin’s revenue growth.

Lupin Limited, a leading global pharmaceutical company, has introduced its generic version of Glucagon for Injection in the United States, strengthening its presence in the critical care and diabetes management segments. The product, designed for emergency treatment of severe hypoglycemia and as a diagnostic aid in gastrointestinal imaging, offers a cost-effective alternative to the reference brand. With this launch, Lupin aims to capture market share in a niche but vital therapeutic area, enhancing accessibility for patients while reinforcing its strategy of diversifying its U.S.

In a strategic push to strengthen its U.S. generics business, Lupin has introduced a generic version of brimonidine tartrate and timolol maleate ophthalmic solution, a widely prescribed combination for reducing intraocular pressure in patients with glaucoma or ocular hypertension. The launch in the world’s largest pharmaceutical market underscores Lupin’s commitment to enhancing its specialty generics portfolio while addressing critical therapeutic areas. Industry estimates place the annual U.S. market for this category at approximately Rs.

Mumbai-based pharmaceutical giant Lupin Ltd has received a crucial regulatory nod from the U.S. Food and Drug Administration (USFDA) for its generic version of Prucalopride tablets, designed for the treatment of chronic idiopathic constipation (CIC) in adults. The approval covers two dosage strengths—1 mg and 2 mg—and positions Lupin to compete in a U.S. market segment estimated at $184 million annually, according to IQVIA MAT data for April 2025.

Two of India’s leading pharmaceutical companies—Dr. Reddy’s Laboratories and Lupin Ltd—are facing regulatory setbacks in the United States after initiating product recalls over quality control and labelling issues. The U.S. Food and Drug Administration (USFDA) flagged both firms in its recent enforcement report, citing Dr. Reddy’s for a labelling discrepancy in its antiepileptic injectable and Lupin for impurity-related concerns in an antidepressant formulation. These recalls, especially the Class I recall issued to Dr.