Lupin Limited announced a significant regulatory achievement, receiving tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Pitolisant Tablets. This approval marks another milestone in the company's expanding generic pharmaceutical portfolio and strengthens its presence in the central nervous system therapy segment.

FDA Approval Details

The U.S. FDA has granted tentative approval for Lupin's Abbreviated New Drug Application covering Pitolisant Tablets in two strengths. The regulatory approval encompasses specific dosage forms and manufacturing specifications that align with established pharmaceutical standards.

Manufacturing and Production

The approved Pitolisant Tablets will be manufactured at Lupin's Nagpur facility in India, leveraging the company's established manufacturing capabilities and quality systems. This facility represents part of Lupin's global manufacturing network, which includes 15 state-of-the-art manufacturing sites worldwide.

The bioequivalence designation confirms that Lupin's generic formulation demonstrates comparable therapeutic efficacy to the reference product Wakix®, manufactured by Bioprojet Europe, Ltd. This approval allows Lupin to offer a generic alternative for the indication specified in the approved labeling.

Company Profile and Market Position

Lupin Limited operates as a global pharmaceutical leader headquartered in Mumbai, India, with products distributed across over 100 markets worldwide. The company maintains a diversified portfolio spanning multiple therapeutic areas including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.

The company's operational infrastructure includes 7 research centers globally and employs over 22,000 professionals. Lupin's business segments encompass branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients, supported by subsidiaries including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Regulatory Compliance

This announcement was made pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015. The disclosure ensures transparency for stakeholders regarding material developments that may impact the company's business operations and market position.

Lupin Limited has announced the allotment of 135,892 equity shares under its Employee Stock Option Plan (ESOP), marking another milestone in its employee incentive program. The pharmaceutical company's Operations and Finance Committee approved this allotment during its meeting held on March 24, 2026.

Share Allotment Details

The allotment comprises 135,892 fully paid-up equity shares with a face value of ₹2/- each. These shares were issued following the exercise of vested options by employees of Lupin Limited and its subsidiaries under the company's existing stock option plans.

Updated Share Capital Structure

Following this ESOP allotment, Lupin's capital structure has been revised upward. The company's issued and paid-up share capital has increased to ₹91,43,58,222, consisting of 45,71,79,111 equity shares of ₹2/- each.

Regulatory Compliance

The allotment was disclosed to stock exchanges in compliance with Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company has informed both the National Stock Exchange of India Limited and BSE Limited about this development.

The disclosure was signed by Amit Kumar Gupta, Company Secretary and Compliance Officer, ensuring proper regulatory adherence and transparency in the share allotment process.