Lupin Limited receives US FDA approval for its Abbreviated New Drug Application for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL.
The approved product is bioequivalent to Ravicti® Oral Liquid and indicated for chronic management of urea cycle disorders.
The reference product Ravicti® had US market sales of USD 337 million for the year ended December 2025.
This regulatory disclosure was filed pursuant to SEBI Listing Regulations and signed by Company Secretary Amit Kumar Gupta.