Lannett Announces Successful FDA Inspections of Three Facilities

Montag, 19.09.2016 12:55 von

PR Newswire

PHILADELPHIA, Sept. 19, 2016 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) recently completed a cGMP inspection of the company'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.  The inspections concluded with two minor 483 observations at the company's facility in Philadelphia and zero observations at the laboratories in Armenia.

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"At a time of particularly rigorous scrutiny by FDA, we achieved a trifecta of successful inspections at our facilities," said Arthur Bedrosian, chief executive officer of Lannett.  "Compliance with Current Good Manufacturing Practices (cGMP) provides confidence to our customers and, ultimately patients, that our products are manufactured under strict adherence to the highest level of quality standards.  I commend our entire team for their dedication to regulatory excellence.  Also, we are proud to have built and maintained a strong working relationship with FDA, especially with our local FDA Philadelphia District, to ensure that all of the medicines we produce are safe and effective. 

"Passing inspection at our overseas stability and bio-study laboratories is an important milestone and paves the way for us to ramp up our product development efforts at these locations and reduce certain R&D costs going forward."

About Lannett Company, Inc.
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.  For more information, visit the company's website at www.lannett.com.

This news release contains certain statements of a forward-looking nature relating to future events or future business performance.  Any such statements, including, but not limited to, the successful outcomes of the FDA inspections, ramping up product development efforts overseas and reducing future operating costs, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully commercialize products upon approval, including acquired products, and Lannett's estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company's Form 10-K and other documents filed with the Securities and Exchange Commission from time to time.  These forward-looking statements represent the company's judgment as of the date of this news release.  The company disclaims any intent or obligation to update these forward-looking statements

Contact:

Robert Jaffe


Robert Jaffe Co., LLC


(424) 288-4098

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SOURCE Lannett Company, Inc.