Last Updated on October 10, 2024 by The Health Master
Hyderabad : Drug firm Granules India announced that it has received USFDA approval to market Bupropion Hydrochloride extended-release tablets, an antidepressant medication to treat major depressive disorder and seasonal affective disorder.
“Granules Pharmaceuticals, Inc (GPI), a wholly-owned subsidiary of the company, has received approval from the US Food & Drug Administration (USFDA) to market the product in strengths of 150 mg and 300 mg,” the drug firm said in a statement.
The company’s product is a generic version of Bausch Health US, LLC’s Wellbutrin XL extended-release tablets.
Commenting on the approval Priyanka Chigurupati, Executive Director, GPI, said “We are pleased to receive approval of Bupropion Hydrochloride (XL) tablet product within the first review cycle of 10 months from filing date.
This product will be a valuable addition to our growing modified release product portfolio in the US market.”
GPI has a total of 50 ANDA approvals from US FDA (48 Final approvals and 2 tentative approvals).
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