Gland Pharma has received regulatory approval from the United States Food and Drug Administration (USFDA) for its Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7%, designated as an over-the-counter (OTC) medication. This approval marks a significant regulatory milestone for the pharmaceutical company in the US market.

Product Approval Details

The approved product represents an important addition to Gland Pharma's ophthalmic care portfolio in the United States. The following table outlines the key details of the regulatory approval:

Market Significance

The OTC classification of this ophthalmic solution allows consumers to purchase the product directly without requiring a prescription from healthcare providers. This regulatory status typically facilitates broader market access and consumer convenience, potentially contributing to increased product adoption in the competitive US eye care market.

Strategic Impact

This USFDA approval strengthens Gland Pharma's regulatory portfolio and expands its presence in the American pharmaceutical market. The approval demonstrates the company's capability to meet stringent US regulatory standards for ophthalmic products, reinforcing its position in the specialized eye care segment.

The addition of this OTC ophthalmic solution to Gland Pharma's approved product lineup enhances the company's ability to serve the US market with accessible eye care solutions.

Gland Pharma Limited has secured approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC). The approval was announced on January 07, 2026, pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.

Product Details and Therapeutic Equivalence

The approved product demonstrates therapeutic equivalence to the reference listed drug (RLD), Pataday Once Daily Relief, 0.7%, manufactured by Alcon Laboratories Inc. This ophthalmic solution is specifically indicated for the treatment of ocular itching associated with allergic conjunctivitis, offering patients an effective over-the-counter option for relief from allergy-related eye symptoms.

Market Response and Stock Performance

Following the announcement, Gland Pharma's shares demonstrated positive market response, closing at ₹1,710.00 on the NSE on January 7, representing an increase of ₹16.70 or 0.99%. This market reaction reflects investor confidence in the company's regulatory achievements and expansion in the US ophthalmic market.

Company Background and Operations

Gland Pharma Limited operates as a generic injectable and ophthalmic-focused pharmaceutical company, established in 1978 in Hyderabad. The company has evolved from a contract manufacturer of small-volume liquid parenteral products to become one of the largest injectable-focused companies globally.

The company maintains a global footprint across 60 countries, including the United States, Europe, Canada, Australia, India, and other international markets. Gland Pharma operates primarily under a business-to-business (B2B) model with an established track record in developing, manufacturing, and marketing sterile injectables.

Strategic Impact and Market Position

This USFDA approval strengthens Gland Pharma's position in the ophthalmic solutions segment and expands its approved product portfolio for the highly regulated US market. The milestone underscores the company's focus on developing high-quality ophthalmic formulations and expanding its presence in the global pharmaceutical sector.

The approval allows Gland Pharma to market a therapeutically equivalent product in the competitive US over-the-counter ophthalmic market, potentially generating additional revenue streams from this specialized therapeutic area.

Product Portfolio and Manufacturing Capabilities

The company's manufacturing portfolio encompasses a comprehensive range of injectable products including vials and ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology products, and ophthalmic solutions. Gland Pharma holds the distinction of pioneering Heparin technology in India, demonstrating its innovation capabilities in specialized pharmaceutical manufacturing.