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Successful inspection for Lannett’s three manufacturing facilities by USFDA

The U.S. Food and Drug Administration (FDA) recently completed a cGMP inspection of the Lannett’s manufacturing facility in Philadelphia, as well as inspections of two facilities located in Armenia (Darmantest Laboratory, the company's pharmacokinetic subsidiary and Firmplace, a stability laboratory with which the company has a strategic relationship).

Two minor 483s were issued at the facility in Philadelphia whereas the laboratories at Armenia received 0 observations.

According to the CEO (Arthur Bedrosian) of Lannett” the inspection was successful at a time when FDA is posing most rigorous scrutiny. Compliance with Current Good Manufacturing Practices (cGMP) provides confidence to the company’s customers and, ultimately patients, that the products manufactured by Lannett are under strict adherence to the highest level of quality standards.”

The company’s CEO also said that “Passing inspection at the overseas stability and bio-study laboratories is an important milestone and paves the way for the company to ramp up their product development efforts at these locations and reduce certain R&D costs going forward."


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