Granules India has recently informed exchanges that the company received USFDA approval for Bupropion Hydrochloride Extended-Release Tablets, a medication for depression and seasonal affective disorder.
In the exchange filing, the company shared, “Bupropion Hydrochloride Extended-Release Tablets USP (SR) are bioequivalent and therapeutically equivalent to Wellbutrin SR Sustained-Release Tablets, 100 mg, 150 mg, and 200 mg, by GlaxoSmithKline LLC. This is a widely prescribed medication for the treatment of major depressive disorder and for the prevention of seasonal affective disorder.”
This is the company’s 67th ANDA approval from the US FDA, expanding its position in the US market. Granules is a vertically integrated Indian pharmaceutical firm with operations in more than 80 countries.
