Approval

Granules India Gets USFDA Nod For Generic Antidepressant Drug

February 04,2022 10:37 AM
- By Admin

Bupropion Hydrochloride is used as an antidepressant medication to treat major depressive disorder and seasonal affective disorder

Drug firm Granules India announced that it has received US FDA 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

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).