Teligent Prepares For Injectables Filings With Strengthened Team

 
• By Akriti Seth
  
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As it prepares to start injectables filings from its facility in Buena, New Jersey, Teligent is putting in place its senior operational and quality functions. 

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Teligent is about to file its first injectables supplement with the FDA and has five pipeline generics lined up, with new operations and quality executive in place • Source: Shutterstock

Teligent intends by the end of September to file its prior approval supplement (PAS) for an injectable drug to the US Food and Drug Administration, triggering an inspection by the agency of the US firm’s injectables facility at its headquarters in Buena, New Jersey. “For this product,” explained president and CEO Jason Grenfell-Gardner, “we have agreed an accelerated review timeline with the FDA that may still allow us to launch this product before the end f 2019, depending on the timing of the FDA’s inspection and their review.”

To support its push to add its own injectables to its topical generics portfolio in the US, Teligent recently appointed...

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