Gland Pharma has secured tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed for Brimonidine Tartrate Ophthalmic Solution, 0.025% (OTC).
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Lumify Ophthalmic Solution, 0.025%, of Bausch & Lomb Inc. It is indicated to relieve redness of the eye.
According to IQVIA, the product had US sales of around $39 million for the twelve months ending September 2025.
Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1850.40 |
| Dr. Reddys Lab | 1310.50 |
| Cipla | 1365.25 |
| Zydus Lifesciences | 939.10 |
| Lupin | 2442.35 |
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