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Teligent Cites Remediation-Related Activites For Poor Quarter

As Company Recalls Lidocaine Anesthetic Solution Due To Super Potency

Executive Summary

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.

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Troubled Teligent Enters Bankruptcy Proceedings As CEO Resigns

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.

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 Announces $140m Operating Loss As Plant Woes Continue

Struggling Teligent underlined the importance of lifting the FDA Warning Letter against its key manufacturing facility in Buena, New Jersey, as its impact slammed the company’s operations last year.

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