Glenmark Get ANDA Nod for Fluphenazine Hydrochloride Tablets

Glenmark Pharmaceuticals has achieved the ultimate endorsement from the United States Food and Drug Administration (USFDA) for Fluphenazine Hydrochloride Tablets USP. These tablets come in four different strengths – 1 mg, 2.5 mg, 5 mg, and 10 mg – and are the generic counterpart of Apothecon Inc.'s Prolixin Tablets, available in the same four strengths. Glenmark Pharmaceuticals Inc., USA, will be responsible for distributing these tablets in the United States. The market for Prolixin Tablets, in doses of 1 mg, 2.5 mg, 5 mg, and 10 mg, generated approximately $18.1 million in annual sales for the 12-month period ending in September 2023, as per IQVIA sales data.

Currently, Glenmark has a total of 189 authorized products that are readily available in the United States. There is a marketplace with 50 ANDA's that are currently awaiting approval from the USFDA. Glenmark is not only focusing on internal submissions , but also actively pursuing external development partnerships to accelerate and strengthen the growth of its current pipeline and portfolio. The aspiration behind Glenmark's inception was to establish itself as a leading global pharmaceutical company driven by research and integration . Their branded generics business exhibits a prominent presence in various emerging economies, predominantly India. The generics industry caters to the demands of advanced markets such as the United States and Western Europe. The API business has a global reach, serving customers in more than 65 countries worldwide. These countries include the United States, multiple nations in the European Union, various countries in South America, and India.