The announcement states that the company’s Fluphenazine Hydrochloride tablet distribution for the US will be handled by Glenmark Pharmaceuticals Inc., USA
The US health regulator has given Glenmark Pharmaceuticals final approval for its generic Fluphenazine Hydrochloride tablets, which are used to treat specific mental disorders, it told on Tuesday. The US Food & Drug Administration (US FDA) has approved the 1 mg, 2.5 mg, 5 mg, and 10 mg strengths of fluphenazine hydrochloride tablets, according to a statement from Glenmark.
The announcement states that the company’s Fluphenazine Hydrochloride tablet distribution for the US will be handled by Glenmark Pharmaceuticals Inc., USA. It also said that these are the same strengths of generic Prolixin tablets as those sold by Apothecon Inc.
According to Glenmark, which referenced IQVIA data, Prolixin tablets in the same strengths generated sales of roughly USD 18.1 million for the entire year that concluded in September 2023.
Out of the 189 products that Glenmark currently has approved for distribution in the US market, 50 ANDAs are still awaiting FDA approval. Glenmark is actively seeking external development partnerships to enhance and expedite the expansion of its current pipeline and portfolio, in addition to the filings it has made internally, the statement added.
Glenmark is a multinational pharmaceutical company operates in the Branded, Generics, and OTC segments. It had recently agreed to divest a 75 per cent stake in Glenmark Life Sciences (GLS) in exchange for Rs 5651 crore (or ₤615 per share) in Nirma.