Lannett Company, Inc. (NYSE Amex:LCI), a manufacturer of generic
pharmaceuticals, today announced that the U.S. Food and Drug
Administration (FDA) has completed its cGMP compliance inspection of
Lannett’s wholly owned subsidiary Cody Laboratories, Inc. (Cody), a
manufacturer/supplier of bulk active pharmaceutical ingredients (API)
and finished dosage form products. The two-week long FDA inspection
resulted in two minor 483 observations, neither of which prevents Cody
from continuing to manufacture products.
“In light of the serious cGMP violations of other prescription drug
manufacturers, we are pleased to come through the FDA’s thorough
inspection with only two minor observations,” said Arthur Bedrosian,
president and CEO of Lannett. “The positive inspection results are
testament to the continued efforts of our employees, who are dedicated
to maintaining a high level of quality and integrity in the products we
manufacture. Completing the inspection is a key step in clearing the way
for FDA approval of our pending application for Hydromorphone Tablets as
well as future product applications.”
About Lannett Company, Inc.
Lannett Company, founded in 1942, develops, manufactures, packages,
markets and distributes generic pharmaceutical products for a wide range
of indications. For more information, visit Lannett 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 company’s future
performance benefiting from the FDA inspection, FDA approval of
Hydromorphone Tablets as well as future product applications, 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, 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.
PondelWilkinson Inc.
Robert Jaffe/Evan Pondel
310-279-5980
