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Gland Pharma Receives USFDA Approval for Olopatadine Eye Drug

Synopsis:


Gland Pharma has received USFDA approval for Olopatadine Hydrochloride Ophthalmic Solution USP 0.7% (OTC). The drug is used to treat ocular itching linked to allergic conjunctivitis, as per the company’s NSE filing dated January 07, 2026.


Source:
Gland Pharma Limited Press Release (NSE Exchange Filings) | Published on Jan 07, 2026

Disclaimer: This content has been published for informational purposes only. Bajaj Broking is not affiliated with, nor does it endorse or assume any responsibility for, the source material. Readers are advised to consult the original publication for complete and accurate context.

As quoted in the press release from Gland Pharma Limited (NSE Exchange Filings), the company has received approval from the United States Food and Drug Administration. The approval is for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).

The disclosure was filed with the stock exchanges on January 07, 2026. The filing was made under Regulation 30 of the SEBI Listing Regulations. The announcement was submitted to both the National Stock Exchange of India and the BSE.

The approval relates to an Abbreviated New Drug Application filed by the company. The product is classified as an over-the-counter ophthalmic solution.

Also Read: Balaji Amines Eligible for ₹258-Cr Subsidy for Maharashtra Unit Expansion

Gland Pharma Limited

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1680-14.80 (-0.87 %)

Updated - 09 January 2026
1700.00day high
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1672.30day low
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34847
VOLUME (BSE)

Key Takeaways

  • Gland Pharma received USFDA approval on January 07, 2026

  • The approval is for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)

  • The drug is used to treat ocular itching caused by allergic conjunctivitis

  • The product is equivalent to Pataday Once Daily Relief 0.7%

  • The disclosure was filed with NSE and BSE

Details of the Approved Drug

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC), is used to treat eye itching. The condition is caused by allergic conjunctivitis. The drug is meant for ophthalmic use.

The company stated that the product is therapeutically equivalent to the reference listed drug. The reference product is Pataday Once Daily Relief 0.7%. It is marketed by Alcon Laboratories Inc.

Therapeutic equivalence means the drug meets USFDA standards. These standards relate to quality, safety, and effectiveness. The press release does not include any commercial or sales-related details.

Regulatory Disclosure and Filing

The announcement was made in line with SEBI disclosure norms. It was issued under Regulation 30 read with Part A of Schedule III of the SEBI Listing Regulations, 2015.

The filing was signed by the Company Secretary and Compliance Officer. The company also stated that the information was placed on its official website. The disclosure was made for information and record purposes.

Gland Pharma Business Overview

Gland Pharma Limited was established in 1978. The company is based in Hyderabad. It operates as a business-to-business pharmaceutical company.

The company focuses on sterile injectables and ophthalmic products. Its product range includes vials, ampoules, pre-filled syringes, and ophthalmic solutions. It supplies products to several global markets.

Gland Pharma Share Price Update

Gland Pharma and share price data was available from the National Stock Exchange. On January 07, 2026, Gland Pharma share price closed at ₹1,710.00 at 16:00 IST.

The stock gained ₹16.70 during the session. This marked an increase of 0.99% from the previous close of ₹1,693.30. The equity opened at ₹1,680.70.

The day’s high was ₹1,710.50. The low was ₹1,680.70.

Published Date : 08 Jan 2026

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