Lannett Company Announces Positive FDA Inspection Results
2009年7月27日 - 8:55PM
ビジネスワイヤ(英語)
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.
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