Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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.

You may also be interested in...



Bankrupt Teligent Announces Opening Bids Totaling $64m For Its Assets

Opening bids totaling $64m have been submitted for bankrupt Teligent’s assets across the US and Canada, weeks after the injectables specialist entered Chapter 11 bankruptcy proceedings.

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. 

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

GB151263

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel