Caraco Successfully Completes FDA Inspection

Apr 30, 2001, 01:00 ET from Caraco Pharmaceutical Laboratories, Ltd.

    DETROIT, April 30 /PRNewswire/ -- Caraco Pharmaceutical Laboratories, Ltd.
 (OTC Bulletin Board:   CARA) has successfully completed an inspection by the
 U.S. Food and Drug Administration (FDA).  Caraco is now in substantial
 compliance with FDA Good Manufacturing Practices (cGMP).
     The Company had been cited last July by the FDA for certain cGMP
 deficiencies, chiefly for record keeping, testing standards, staff training
 and quality systems.  The FDA citation did not call for a plant shutdown or
 product recall.
     In response to the FDA citation, the Company scaled-back manufacturing and
 new-drug development to focus on FDA cGMP.  The Company completed substantial
 changes to it facilities and procedures, added professionals to quality
 control, quality assurance and regulatory areas and developed a company-wide
 cGMP-compliance culture.
     Narendra Borkar, CEO, said, "The cGMP compliance allows Caraco to resume
 full-scale manufacturing and drug research and to receive FDA approvals for
 new drugs.  The Company has a number of generic drugs pending FDA approval and
 in various stages of development.  The cGMP compliance has cleared the way for
 FDA approvals and for us to move aggressively back into drug development."
     The Company has an extensive R&D Center at its Detroit headquarters
 complex and receives R&D support from Sun Pharmaceutical Industries Ltd., a
 specialty pharmaceutical firm in India.  Sun is a Caraco stockholder and has
 agreed to supply Caraco with technology for 25 generic drugs.  To date, Caraco
 has received technology for nine products.
     Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,
 manufactures and distributes generic and private-label prescription drugs to
 the nation's largest wholesalers and distributors, drugstore chains and
 healthcare systems.
     This news release contains forward-looking statements made pursuant to the
 safe harbor provisions of Section 27A of the Securities Act of 1933, Section
 21E of the Securities Act of 1934 and the Private Securities Litigation Reform
 Act of 1995.  Such statements are based on management's current expectations
 and are subject to a number of risk factors and uncertainties that could cause
 actual results to differ materially from those described in the forward-
 looking statements.  These risk factors are contained in the Corporation's
 filings with the Securities and Exchange Commission.
 
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SOURCE Caraco Pharmaceutical Laboratories, Ltd.
    DETROIT, April 30 /PRNewswire/ -- Caraco Pharmaceutical Laboratories, Ltd.
 (OTC Bulletin Board:   CARA) has successfully completed an inspection by the
 U.S. Food and Drug Administration (FDA).  Caraco is now in substantial
 compliance with FDA Good Manufacturing Practices (cGMP).
     The Company had been cited last July by the FDA for certain cGMP
 deficiencies, chiefly for record keeping, testing standards, staff training
 and quality systems.  The FDA citation did not call for a plant shutdown or
 product recall.
     In response to the FDA citation, the Company scaled-back manufacturing and
 new-drug development to focus on FDA cGMP.  The Company completed substantial
 changes to it facilities and procedures, added professionals to quality
 control, quality assurance and regulatory areas and developed a company-wide
 cGMP-compliance culture.
     Narendra Borkar, CEO, said, "The cGMP compliance allows Caraco to resume
 full-scale manufacturing and drug research and to receive FDA approvals for
 new drugs.  The Company has a number of generic drugs pending FDA approval and
 in various stages of development.  The cGMP compliance has cleared the way for
 FDA approvals and for us to move aggressively back into drug development."
     The Company has an extensive R&D Center at its Detroit headquarters
 complex and receives R&D support from Sun Pharmaceutical Industries Ltd., a
 specialty pharmaceutical firm in India.  Sun is a Caraco stockholder and has
 agreed to supply Caraco with technology for 25 generic drugs.  To date, Caraco
 has received technology for nine products.
     Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops,
 manufactures and distributes generic and private-label prescription drugs to
 the nation's largest wholesalers and distributors, drugstore chains and
 healthcare systems.
     This news release contains forward-looking statements made pursuant to the
 safe harbor provisions of Section 27A of the Securities Act of 1933, Section
 21E of the Securities Act of 1934 and the Private Securities Litigation Reform
 Act of 1995.  Such statements are based on management's current expectations
 and are subject to a number of risk factors and uncertainties that could cause
 actual results to differ materially from those described in the forward-
 looking statements.  These risk factors are contained in the Corporation's
 filings with the Securities and Exchange Commission.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X21521367
 
 SOURCE  Caraco Pharmaceutical Laboratories, Ltd.