Teligent, Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced that it has filed a prior approval supplement (PAS) for ranitidine hydrochloride injection
BUENA, N.J., Oct. 28, 2019 (GLOBE NEWSWIRE) -- Teligent Inc. (NASDAQ: TLGT), a New Jersey-based specialty generic pharmaceutical company, today announced that it has filed a prior approval supplement (PAS) for ranitidine hydrochloride injection. This is the planned first injectable product to be manufactured out of the newly completed expansion of its manufacturing site in Buena, NJ. As this is the first injectable filing related to the new expansion, the PAS review will be subject to a pre-approval inspection (PAI) of the manufacturing site by the FDA, which the Company expects to occur within four months of the date of the filing.
Since the FDA’s announcement on September 13, 2019, alerting patients and health care professionals that certain ranitidine products may contain unsafe levels of the chemical NDMA, the Company has taken precautionary measure of performing additional tests and added necessary controls to confirm that its product is within FDA approved safe ranges for NDMA.
“This is a big step forward in terms of realizing our long-term business plan,” said CEO Jason Grenfell-Gardner. “The filing of the PAS marks the culmination of years of cross functional effort, and I want to offer my sincere gratitude and congratulations to the employees of Teligent who have helped to make this possible. Teligent has put considerable resources into preparing for the PAI and we look forward to bringing our first internally manufactured injectable product to the market.”
About Teligent, Inc.
Teligent is a specialty generic pharmaceutical company. Our mission is to be a leading player in the specialty generic prescription drug market. Learn more on our website www.teligent.com.
Contact:
Damian Finio
Teligent, Inc.
856-336-9117
www.teligent.com
Forward-Looking Statements
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