Aurobindo Pharma has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per ml. The approved product is bioequivalent and therapeutically equivalent to the reference listed drug Ravicti Oral Liquid of Horizon Therapeutics U.S. Holding LLC.

Market Opportunity and Product Details

The newly approved Glycerol Phenylbutyrate Oral Liquid represents a significant commercial opportunity in the US pharmaceutical market. The product targets a substantial market segment with specific therapeutic applications.

Therapeutic Application and Manufacturing

Glycerol Phenylbutyrate Oral Liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and amino acid supplementation alone. This specialized therapeutic application addresses a critical medical need in the treatment of rare metabolic disorders.

The company will manufacture the approved product at its Unit-III facility and plans an immediate launch in the US market. This rapid market entry strategy demonstrates Aurobindo Pharma's manufacturing readiness and regulatory compliance capabilities.

Regulatory Portfolio Expansion

With this latest approval, Aurobindo Pharma now holds a total of 579 ANDA approvals from the USFDA, comprising 556 final approvals and 23 tentative approvals. This milestone reinforces the company's strong regulatory track record and ability to navigate complex approval processes.

Strategic Significance

This USFDA approval strengthens Aurobindo Pharma's presence in the US pharmaceutical market and expands its product portfolio in specialized therapeutic areas. The approval demonstrates the company's continued focus on developing niche pharmaceutical products that address specific medical conditions and represent meaningful commercial opportunities in the global healthcare market.

Aurobindo Pharma Limited has announced the opening of its buyback offer for up to 54,23,728 equity shares at a price of ₹1,475 per share, payable in cash. The aggregate consideration for the buyback amounts to ₹800,00,00,000, excluding transaction costs. The offer, which follows the tender offer route using the stock exchange mechanism, opened on April 23, 2026, and will close on April 29, 2026. The last date for receipt of completed tender forms and other specified documents by the registrar is April 29, 2026, on or before 5.00 PM IST.

The company has dispatched the letter of offer and tender form, along with the share transfer form dated April 21, 2026, through electronic means to all eligible shareholders holding equity shares as on the record date of April 17, 2026. Shareholders whose email IDs are registered with the company or depositories received these documents electronically. In accordance with Regulation 9(ii) of the Buyback Regulations, physical copies of the letter of offer will be dispatched by registered post, speed post, or courier upon request from eligible shareholders.

The entitlement ratio for eligible shareholders has been categorized into two segments. Small shareholders in the reserved category are entitled to 7 equity shares out of every 61 equity shares held on the record date. The general category for all other shareholders is entitled to 2 equity shares out of every 249 equity shares held on the record date. Shareholders can verify their entitlement by visiting the registrar's website and following the specified process, which involves selecting the company name, holding type, and entering relevant details such as folio number, DPID/Client ID, or PAN.

Axis Capital Limited has been appointed as the manager to the offer, while KFin Technologies Limited serves as the registrar to the offer. The letter of offer is available on the company's website, the registrar's website, and the manager to the buyback's website. The company has also published a corrigendum to the public announcement, revising the premium over the volume weighted average market price of the equity shares on BSE during the two weeks preceding the intimation date to 12.72% instead of the previously stated 13.18%. The buyback offer is being conducted under the Securities and Exchange Board of India (Buyback of Securities) Regulations, 2018, as amended.