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Troubled Teligent Enters Bankruptcy Proceedings As CEO Resigns

Expects To Conclude Sale Of Entire Business Or Core Assets By Early 2022

Executive Summary

Teligent is pursuing an asset sale process to “maximize the value of the company” after entering into Chapter 11 bankruptcy proceedings in the US. The firm – which has also seen CEO Tim Sawyer resign – had been struggling of late with remediation issues to address a warning letter at its Buena manufacturing facility in New Jersey, as well as a recent recall.

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Teligent Cites Remediation-Related Activites For Poor Quarter

New Jersey-based Teligent reported a low quarter as the company continues to focus on remediation measures to lift the FDA warning letter hanging over its Buena New Jersey manufacturing facilty. Teligent has also recently recalled a batch of its 4% lidocaine hydrochloride topical solution because the firm’s testing found it to be super potent.

FDA Begins cGMP Reinspection Of Teligent’s Key Facility

Teligent is relying upon the FDA approval of its manufacturing capacity at Buena, New Jersey to reintroduce its products in the market and “significantly expand” its production capabilities within the sterile injectables segment. 

Teligent Slammed By FDA Warning Letter

Rather than blame employees for ignoring 397 product complaints, Teligent should have fixed complaint handling system, US FDA warning letter says.

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