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The product is the first generic version of AZOPT by Teva Pharmaceuticals. The product will be developed and manufactured by Indoco Remedies for TEVA at its facility in Goa.
The ANDA approved by the USFDA for brinzolamide ophthalmic suspension 1%, is used to treat high pressure inside the eye due to ocular hypertension and open-angle glaucoma. Brinzolamide ophthalmic suspension 1% works by decreasing the amount of fluid within the eye. According to IQVIA data, the US market size of this product is $184 million as of December 2020.
Commenting on this achievement, Aditi Kare Panandikar, MD of Indoco Remedies said, "This first-to-market generic version of AZOPT (brinzolamide ophthalmic suspension 1%, developed by Indoco) in the U.S. brings in an enormous opportunity to Indoco to serve the patients with a generic option. It also provides us immense satisfaction to be part of the journey in developing and securing approval from the US regulators for such Complex Generic products (ophthalmic suspensions), ensuring access to affordable and quality medicines."
She further added, “Indoco is vertically integrated for brinzolamide API (manufactured at Patalganga site), which gives an edge to ensure continuity in commercial supplies.”
Shares of Indoco Remedies saw bargain hunting after falling 7% in the previous five sessions. Indoco Remedies is a fully integrated, research-oriented pharma company with presence in 55 countries.
The drug company's consolidated net profit jumped 169.2% to Rs 25.1 crore in Q3 FY21 from Rs 9.3 crore in Q3 FY20. Net revenue during the quarter rose 17.6% year-on-year (YoY) to Rs 333.3 crore.
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