DETROIT, Jan. 3, 2011 /PRNewswire/ — Caraco Pharmaceutical
Laboratories, Ltd. (NYSE Amex:
CPD) announced that based on remediation efforts to date, it
does not expect to commence the manufacture and distribution of
products from its Detroit facility by the end of Caraco’s Fiscal
Year 2011, ending March 31, 2011. The Company had previously
disclosed its belief that two products would commence manufacture
in the Detroit facility prior to the end of Fiscal 2011. As
provided under the terms of the Consent Decree of Condemnation,
Forfeiture and Permanent Injunction entered into with the FDA on
September 29, 2009, before resuming the manufacture and
distribution of any product from the Company’s facilities, a number
of significant steps and processes are required to be completed,
and certifications and approvals from both outside experts (current
good manufacturing practice “cGMP” consultants) and the FDA are to
be obtained. In evaluating and discussing with the cGMP
experts the remediation steps completed to date and those yet to be
completed, the Company has determined that it will not be able to
begin the manufacture and distribution of products by the end of
Fiscal Year 2011. The Company’s remediation efforts towards
the resumption of manufacturing and distribution from its
facilities are still ongoing, but the Company is unable to predict
when such manufacturing and distribution will resume. As
previously disclosed, and as always is the case in matters such as
these, there is no assurance that the remediation efforts will be
successful or result in resolution of the FDA compliance
issues.
Detroit-based Caraco Pharmaceutical Laboratories, Ltd.,
develops, manufactures, markets and distributes generic
pharmaceuticals to the nation’s largest wholesalers, distributors,
drugstore chains and managed care providers.
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