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Glenmark Chief: Running A Facility In The US Has Been A Struggle

Firm Primes Global Scale In Respiratory Segment

 
• By Anju Ghangurde

Glenmark readies scale up in the respiratory segment, with Ryaltris set for a US debut and a filing for a generic rival to Flovent anticipated. Running a facility in that market, though, is not an easy task, says the firm's leadership.

Running US SIte Has Its Challenges Says Glenmark • Source: Shutterstock

Glenmark Pharmaceuticals Limited remains upbeat about opportunities in the US, a market where the Indian firm has quite a lot going on and is pivotal to propel its respiratory ambitions, but running manufacturing operations there apparently hasn’t been easy.

The company’s first US facility in Monroe, North Carolina, designed to manufacture a range of fixed dose formulations and generally seen as the “foundation for future product approvals”, hasn’t quite taken off the way the Indian company would have liked it to. The site failed to make the compliance cut at a recent inspection by the US Food and Drug Administration and hasn’t seen launches since August 2021 following a voluntary recall of products

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