Breckenridge Pharmaceutical Inc, a subsidiary of Japan-based Towa Pharmaceutical, announced on Thursday that it has introduced Zolpidem Tartrate Extended-Release Tablets, USP (generic for Ambien(R) CR) manufactured by Centaur Pharmaceuticals Pvt. Ltd.
Breckenridge Pharmaceutical is to market the product with its own label and offer it in 6.25mg and 12.5mg strengths in bottles of 100.
According to industry sales data, Ambien CR and its generics had annual sales of USD42m during the twelve months ending May 2021. The United States Food and Drug Administration (FDA) earlier granted final approval for this product's Abbreviated New Drug Application.
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