Monroe Site ‘Critical’ For Glenmark In US
Commercialization From Monroe Site Is Key To Glenmark’s US Step-Up
Glenmark expects its first US manufacturing site to go commercial next year, accelerating growth in that market, while it sets right certain compliance blips back home. The Indian firm is also on course to divest certain non-core assets but notes that bringing in a minority partner for its API unit is not a priority.
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Glenmark has struck a deal with private equity firm True North for its gynecology business in India and Nepal.
Glenmark, which has been the recipient of a string of notices from the US Food and Drug Administration over manufacturing quality issues, is again under fire with the regulator blasting the leading Indian drugmaker for failing to ensure “consistent production” of safe and effective products.
Firm should have addressed complaints of gritty topicals and compromised container/closures, and its own findings about overheated creams, the US FDA says.