Lupin Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL. The announcement was made on May 5, 2026, as part of a disclosure pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Product Overview

The approved product, Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, is bioequivalent to the reference listed drug (RLD) Ravicti® Oral Liquid, 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC. The following table summarizes the key details of the approved product:

Therapeutic Indication

Glycerol Phenylbutyrate Oral Liquid is indicated for the chronic management of patients with urea cycle disorders (UCDs) that cannot be managed by dietary protein restriction and/or amino acid supplementation alone. UCDs are a group of metabolic conditions that affect the body's ability to process nitrogen, requiring specialized pharmaceutical intervention for long-term management.

Market Context

According to IQVIA MAT DEC 2025 data, product sales for Glycerol Phenylbutyrate Oral Liquid — referencing the RLD Ravicti® — stood at USD 337 million for the year ended December 2025. This figure reflects the scale of the addressable market that Lupin's newly approved generic product will compete in within the United States.

About Lupin Limited

Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Key operational highlights include:

• 15 state-of-the-art manufacturing sites globally
• 7 research centers globally
• A dedicated workforce of over 24,000 professionals
• Subsidiaries: Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions

Note: Ravicti® is the registered trademark of Horizon Therapeutics U.S. Holding LLC, a subsidiary of Amgen Inc.

Lupin Limited allotted 36,752 fully paid-up equity shares of ₹2/- each on May 4, 2026, pursuant to the exercise of vested options granted to employees of the company and its subsidiaries. The allotment was approved by the Operations and Finance Committee at its meeting held on May 4, 2026, and was disclosed under Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

ESOP Allotment Details

The shares were allotted under the company's Stock Option plans, following the exercising of vested options by eligible employees. The key parameters of this allotment are summarised below:

Impact on Share Capital

Following the allotment, the issued and paid-up share capital of Lupin Limited has been revised upward. The updated capital structure is as follows:

The disclosure was made by Amit Kumar Gupta, Company Secretary and Compliance Officer, on behalf of Lupin Limited, in accordance with applicable listing regulations.