Gland Pharma Receives USFDA Approval for OTC Olopatadine Eye Drop

Gland Pharma USFDA approval marks a fresh milestone for the Hyderabad-based drugmaker, as it has received clearance from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC).

With the approval, the company would be able to introduce the product in the United States as an over-the-counter drug to treat eye allergies.

The approved formula is therapeutically equal to Pataday Once Daily Relief, 0.7 percent, which is sold by Alcon Laboratories Inc. It is prescribed to cure eye itching associated with allergic conjunctivitis, a disease that afflicts millions of seasonal and year-round allergy victims in the U.S. market.

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This USFDA approval helps Gland Pharma to consolidate its ability in the ophthalmic space of U.S. generics. The product makes it richer in the expanding range of sterile and non-sterile formulas that are created by the company to serve the highly regulated markets, and it also increases its footprint in the OTC.

Gland Pharma was established in 1978 and it has grown to become one of the most prominent injectable-based pharmaceutical companies in the entire world. The company has its head office at Hyderabad and mostly operates on business-to-business basis and delivers its products to over 60 countries such as the United States, Europe, Canada, Australia and India.

The company has established a good record in sterile injectables and ophthalmic products, which have the ability of vials, ampoules, pre-filled syringes, lyophilized formulations, infusions, oncology products and ophthalmic solutions. Gland Pharma also has a good reputation as the pioneer of heparin technology in India which has strengthened its status as a good partner in the production of pharmaceuticals worldwide.