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• 1984
- Caraco Pharmaceutical
Laboratories, Ltd., established in Detroit,
Michigan.
• 1990
- Caraco constructs 70,000+ sq ft facility in New
Center Area with
support from the Economic Development Corporation of the City
of
Detroit.
• 1994
- Caraco became a public company.
• 1996
- Caraco receives first ANDA
approval for Metoprolol Tartrate Tablets.
• 1997
- Caraco enters into an
agreement with Sun Pharmaceutical Industries,
Ltd. for technology transfers.
• 1998
- Two new products are introduced, and a total of 21 generics are
in
various stages of development.
• 2000
- FDA restores cGMP standing after warning to focus on laboratory and
manufacturing documentation.
• 2001
- Caraco
receives cGMP clearance from FDA. FDA waives pre- approval
inspection for 9 pending ANDAs. FDA approves 3 products.
• 2002
- FDA approves 6 products. Caraco announces its first
gross quarterly
profit ever. Signs new deal with Sun Pharma for an
additional
25 products over 5 years. Capital investment of $1.6 million to
expand
capacity.
• 2003 - Net sales cross $45
million. - Gross profit $26 million. -
Positive cash flows exceeding $15 million. - Capital
investment of $2.5 million to expand capacity. - Four
consecutive profitable quarters and first profitable year.
- EDC loan restructured. - Sun loan paid off.
- New 55,000+ sq. ft. leased premises to accommodate regulatory affairs,
sales and marketing, accounting and commercial
departments and
warehousing.
• 2004 - Fourth
consecutive year of record sales growth. - Sales top $60.3
million - Up 33% year-over-year. - Net cash generated from
operations exceeds $22 million. - All debt retired with $33.0
million in debt payments. - $4 million in plant renovations
increase efficiency and raise production
capacity. - FDA approvals received for Citalopram,
Mirtazapine and 25mg strength
of Metoprolol Tartrate. - Two drugs launched -
Citalopram and Mirtazapine. - Formulary increased to 19 drugs
in 38 strengths and 92 package sizes. - Total 18 of 25
products identified under Sun Pharma R&D Agreement. - Seven
biostudies completed. - Six ANDAs filed - Total of six
pending approval. - Fiscal 2006 sales forecast to grow
15.20%. - Fiscal year changed to March 31 to synchronize with
Sun Pharma (2005).
• 2005
- Transition Period in which we
changed our fiscal period from
Calendar year to a Fiscal year effective April 2005.
• Fiscal 2006
- Sales of $83 million, representing an increase of 29%
over the
corresponding period of fiscal 2005. - FDA Approvals of Fluvoxamine, Carbamazapine,
Tramadol with APAP,
Clozapine 50mg, tentative approval on Zolpidem Tartrate,
tentative
approval on Carvedilol . - Filed 10 products with
the FDA in fiscal 2006. - 5th consecutive year of growth.
- Enhanced sales team with additional staff and succession planning.
- Improved technical team with additional staff and succession planning.
- Increased Forecast of estimated growth to 25-30% growth. -
Implemented systems and staffing to manage growth. -
Completed manufacturing expansion within facility increasing usable sq
ft to 80,000 sq. ft. Increased total footprint to 142,000 sq
ft. - Increased manufacturing capacity by 35%. - 25
products identified for Sun agreement, 20 passed bio-studies and 19
of those are filed with the FDA. - Updated our
enterprise wide system for streamlining and improving
process time. - Developed Clozapine Registry Web
site for electronic patient
monitoring information. - Awarded summary judgment
in favor of Caraco on Tramadol w/APAP
litigation. - Maintained gross profit of 49% which
is above the generic industry
average. - Award of Top 500 fastest growing
technology companies Ranked 96th by
Deloitte & Touche. - Award of Future 50
representing the top 50 growth companies in Metro
Detroit based on sales and employment.
• Fiscal 2007
- Record annual sales of $117 million for the full year of fiscal 2007,
which
represents an increase of 41% over the corresponding period
of fiscal
2006. - Entered into a definitive agreement to
market Sun ANDAs that are either
approved or awaiting approval at the FDA. - Signed
three definitive agreements with third party developers or
formulators. - Acquired a packaging facility, which
has been fully transitioned.
- Recognized by one of the “Big Three” wholesalers in U.S. as Best Trade
Representative for companies under $100 million in sales with
that
wholesaler. - Filed 19 ANDAs (11 products) with the
FDA bringing total ANDAs awaiting
approval to 29 (21 products), including one tentative
approval. - Launched 11 products (five Caraco ANDAs and six
Sun ANDAs): Baclofen,
Carbamazepine 200 mg, Glipizide, Meloxicam, Fluvoxamine,
Gabapentin
Caps, Gabapentin Tabs, Metformin HCL ER, Ondansetron
Injection,
Phenytoin Sodium Capsules ER, and Zonisamide.
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