The approval is for two packet sizes – 1.875 grams and 3.75 grams.
Colesevelam Hydrochloride is the generic version of Daiichi Sankyo’s oral suspension Welchol.
Welchol had annual sales of approximately $73.0 million for the two pack sizes according to IQVIA.
Glenmark said it now has 138 products authorized for distribution in the U.S., and another 62 generic applications pending with the FDA.
“In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio,” it said.
Glenmark Pharmaceuticals is a pharmaceutical company headquartered in Mumbai, India that was founded in 1977 by Gracias Saldanha as a generic drug and active pharmaceutical ingredient manufacturer; he named the company after his two sons.
Glenmark has 16 manufacturing facilities in Europe, India and the U.S., operating under Good Manufacturing Practices.