Mumbai, India (CU)_ Indian pharma Granules India announced on Thursday that the US Food and Drug Administration has granted permission to sell Bupropion Hydrochloride extended-release tablets, an antidepressant medication, in the American market. According to the statement from the Hyderabad-based pharma firm, the US Food and Drug Administration (USFDA) has authorized Granules Pharmaceuticals, Inc (GPI), a wholly-owned subsidiary of the company, to market the medication in 150 mg and 300 mg dosages.
The firm’s product is a generic version of Wellbutrin XL extended-release tablets manufactured by Bausch Health US, LLC. The antidepressant medication bupropion hydrochloride is widely employed in addressing major depressive disorder and seasonal affective disorder.
Priyanka Chigurupati, Executive Director of GPI, expressed delight over the approval and the company’s expansion into the US market. He stated, “We are pleased to receive approval of Bupropion Hydrochloride (XL) tablet product within 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”.
This product will complement the firm’s growing portfolio of modified release products in the US market. According to MAT Dec 2021, IQVIA/IMS Health, the US market for Bupropion Hydrochloride extended-release tablets at present is worth approximately USD 661 million per year. Granules reported that it currently owns 50 abbreviated new drug application (ANDA) approvals received from the US Food and Drug Administration.
Granules India Limited is an Indian pharmaceutical manufacturing giant headquartered in Hyderabad, India. Granules manufactures numerous off-patent drugs, such as Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale basis for customers in the regulated and rest of the global markets. Granules India Limited entered CRAMS segment, which specializes on contract research and manufacturing.
