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  1. Glenmark Pharma shares rise after co announces USFDA approval for brimonidine tartrate and timolol maleate ophthalmic solution

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Glenmark Pharma shares rise after co announces USFDA approval for brimonidine tartrate and timolol maleate ophthalmic solution

Upstox

2 min read | Updated on May 17, 2024, 16:30 IST

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SUMMARY

Glenmark said brimonidine tartrate and timolol maleate ophthalmic solution is bioequivalent and therapeutically equivalent to Combigan’s ophthalmic solution of AbbVie Inc. It will be distributed in the United States by Glenmark Pharmaceuticals Inc, USA. The company cited IQVIATM’s sales data for FY24 which reported annual sales of Combigan’s ophthalmic solution at $290 million.

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Glenmark Pharmaceuticals.webp

Glenmark Pharma shares rise after co announces USFDA approval for brimonidine tartrate and timolol maleate ophthalmic solution

Glenmark Pharmaceuticals on Friday announced the company has received final approval from the United States Food and Drug Administration (USFDA) for brimonidine tartrate and timolol maleate ophthalmic solution, 0.2%|0.5%. Following the announcement, shares of Glenmark Pharmaceuticals were trading nearly 1% higher.
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Glenmark said brimonidine tartrate and timolol maleate ophthalmic solution is bioequivalent and therapeutically equivalent to Combigan’s ophthalmic solution of AbbVie Inc. It will be distributed in the United States by Glenmark Pharmaceuticals Inc, USA.

The company cited IQVIATM’s sales data for FY24 which reported annual sales of Combigan’s ophthalmic solution at $290 million.

Currently, Glenmark has a portfolio of 196 products that have been authorised for distribution in the United States. Additionally, the company has 51 ANDAs with pending approval from the USFDA.

Last month, the firm received an ANDA approval for Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg.

The firm recently announced that it has entered into a securities subscription and shareholder’s agreement with O2 Renewable Energy XXIV and O2 Energy SG to enhance the share of renewable power in its operation. The acquisition of shares will enable Glenmark Pharmaceuticals to invest in renewable energy and thereby comply with regulatory requirements for being a captive user under Indian electricity laws. The firm said it will acquire a minimum 26% stake on a fully diluted basis in O2 Renewable Energy XXIV to qualify for captive requirements as per the provision of the Electricity Act, 2003.

During the third quarter of fiscal year 2024, Glenmark Pharmaceuticals reported a net loss of ₹330.82 crore compared to a profit of ₹290.76 crore in the corresponding quarter of the previous fiscal. The firm is set to announce its Q4FY24 results on May 27, 2024.

Shares of the company have risen nearly 19% since the beginning of the year. The stock has gained over 66% in the last one year.

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