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Glenmark Shares Surge as USFDA Grants Approval for Generic Drug Used to Treat Certain Mental Disorders

Glenmark Pharma’s current US portfolio includes 198 products authorised for distribution.

Shares of Glenmark Pharmaceuticals Ltd rallied over 2% as the company received final approval from the United States Food & Drug Administration (US FDA) for Fluphenazine Hydrochloride Tablets USP in strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg. The tablets will be distributed in the United States by Glenmark Pharmaceuticals Inc., USA.

Following this announcement, shares of Glenmark hit an intraday high of Rs 772, surging nearly 2.2% from the last closing price on the National Stock Exchange (NSE). At 12:35 pm, the scrip was trading 1.87% higher at Rs 769.55. 

Fluphenazine is an antipsychotic medication used to treat conditions like schizophrenia and psychotic symptoms such as hallucinations, delusions, and hostility. These tablets are the generic versions of Prolixin Tablets, available in the same strengths and manufactured by Apothecon Inc. 

For the 12 months ending in September 2023, Prolixin tablets with the same strengths achieved annual sales of approximately $18.1 million, according to IQVIA data.

Glenmark has a portfolio of 189 products authorised for distribution in the US market and 50 abbreviated New Drug Applications pending approval with the US FDA. 

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