Lupin Share Price Edges Higher on USFDA Nod for Eye Gel

Market Performance

Lupin's share price experienced an uptick in early trading on July 2, following a key regulatory milestone.

• At 09:20 AM, Lupin shares were trading at ₹1,969.70, up by ₹8.40 or 0.43% on the BSE.
• The stock is currently:
  • 18.05% below its 52-week high of ₹2,403.45 (hit on January 2, 2025)
  • 21.1% above its 52-week low of ₹1,626.45 (recorded on July 3, 2024)

Lupin's market capitalization now stands at ₹89,959.37 Crore, reflecting strong investor interest amid recent strategic developments.

Main News

Lupin experienced an upward push on July 2 after receiving US FDA approval for its abbreviated new drug application (ANDA) for Loteprednol Etabonate Ophthalmic Gel, 0.38%.

• The drug is bioequivalent to Lotemax SM Ophthalmic Gel, marketed by Bausch & Lomb Inc.
• Lupin has exclusive first-to-file status, qualifying the company for 180 days of marketing exclusivity in the US generic drug market.
• The product will be manufactured at the Pithampur facility in India.
• It is a corticosteroid gel used to treat postoperative inflammation and pain after eye surgeries.

Company Developments

In addition to the USFDA nod, Lupin made several notable strategic announcements:

Consumer Healthcare Business Restructuring

• On July 1, 2025, Lupin carved out its consumer healthcare division into a wholly owned subsidiary named LupinLife Consumer Healthcare Ltd. (LCH).
• The move aims to develop a specialized arm to tap into India's fast-expanding self-care market.

New Launches and Global Collaborations

• In June 2025, the company launched Prucalopride Tablets (1 mg and 2 mg) in the US following US FDA approval.
• Lupin also inked a license and supply agreement with Sino Universal Pharmaceuticals (SUP) to commercialize Tiotropium Dry Powder Inhaler (DPI), 18 mcg/capsule, in China.
• This partnership focuses on addressing chronic obstructive pulmonary disease (COPD) in the region.

Company Snapshot

Here's a quick look at Lupin's stock highlights:

Summary of the Article

Lupin's share price inched higher on July 2, backed by regulatory approval from the USFDA for its Loteprednol Etabonate Ophthalmic Gel. The company also announced plans to restructure its consumer healthcare business and expand into new markets through product launches and international partnerships.

The positive developments, particularly the exclusivity period for the new ophthalmic product, position Lupin well in the generics market, contributing to investor confidence and resilience in its share price.