Navigation Links
Caraco Pharmaceutical Laboratories, Ltd. Reports Results for the Fiscal Year 2009, Updates on FDA Inspection
Date:5/28/2009

lated expenses, increased R&D activity, and increases in other expenses in an effort to file additional products with the FDA. We filed ten Abbreviated New Drug Applications ("ANDAs") relating to nine products with the FDA during Fiscal 2009 as compared to seven products filed in 2008. This brings our total number of ANDAs pending approval by the FDA to 29 (including four tentative approvals) relating to 25 products. We also submitted ten other various filings with the FDA including those related to new sources on the Active Pharmaceutical Ingredients and alternative manufacturing sites in order to improve our costs on certain products.

We earned a net pre-tax income of $29.5 million in Fiscal 2009, compared to a net pre-tax income of $42.4 million in Fiscal 2008. The reduction in net pre-tax income from last year was primarily due to lower gross profits resulting from price erosion of the products sold, the mix of distributed products sold and the provision for losses expected from the product recalls initiated during the end of Fiscal 2009 and beginning of Fiscal 2010. Net income decreased to $20.5 million during Fiscal 2009 from net income of $35.4 million during the Fiscal 2008.

Mr. Movens stated, "On March 11, 2009 the FDA began an inspection as a follow-up to the October, 2008 Warning Letter. This inspection covers all of the Company's quality and production systems. The inspection concluded on May 12, 2009. The FDA investigators provided the Company with a list of their observations on FDA Form 483. The Company has committed to provide a written response to these observations within 30 days. It is unlikely that we will receive any approvals for any new products out of our Detroit facility until the FDA reviews our remediation response and makes a determination of our status. Currently our status remains unchanged. In January 2009 we changed our leadership in both manufacturing and quality control in order to better
'/>"/>

SOURCE Caraco Pharmaceutical Laboratories, Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5

Related medicine news :

1. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
2. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Adipex-P(R)
3. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Coreg(R)
4. Caraco Pharmaceutical Laboratories Ltd. Announces Tentative FDA Approval for Generic Zyrtec Chewable(R)
5. Caraco Pharmaceutical Laboratories Ltd. Reports Record Net Sales for the Second Quarter and First Six Months of Fiscal 2008
6. Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lamictal(R)
7. Caraco Pharmaceutical Laboratories, Ltd. Announces Tentative FDA Approval for Generic Lexapro(R)
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Norvasc(R)
9. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Zyrtec Allergy Tablets(R) and Zyrtec Hives Relief Tablets(R)
10. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic OTC Versions of Childrens Zyrtec(R) Chewable Tablets for Allergy Relief and Childrens Zyrtec(R) Chewable Tablets for Hives Relief
11. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Metaglip(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/17/2014)... Present-day Europeans are the descendants of at least ... new study. Previous research suggested that ... farmers. But, a new genetic analysis involving ancient ... of Ancient North Eurasians. Nearly all present-day Europeans ... researchers from Harvard Medical School said. , , ...
(Date:9/17/2014)... HealthDay Reporter WEDNESDAY, Sept. 17, 2014 (HealthDay ... why antibiotic-resistant bacteria can thrive in a hospital setting. ... the culprit. They can easily enter bacteria and move from ... makes bacteria drug-resistant, a new study finds. "The plasmids ... class of antibiotic called carbapenems," said the study,s co-author, Dr. ...
(Date:9/17/2014)... might be able to reduce the need for invasive ... autoimmune disease lupus. , In a new study, researchers ... from nephritis kidney inflammation to interstitial fibrosis, ... A kidney biopsy is the only existing way to ... extent. , The model could also be used to ...
(Date:9/17/2014)... 17, 2014 Today, Blue Shield ... in third-quarter grantmaking. This body of grants aims to ... innovations in care delivery, as well as to develop ... Grants will also strengthen the capacity of both domestic ... and create new entry points for domestic violence screening ...
(Date:9/17/2014)... 17, 2014 In a country where ... on a regular basis, how can Americans find healthy ... Hyland’s Stress Challenge , a 5-day interactive journey ... stress-free life. From September 29th – October 3rd, ... content relating to specific topics that promote natural solutions ...
Breaking Medicine News(10 mins):Health News:Europeans Are Descendants of at Least 3 Ancient Human Groups: Study 2Health News:Europeans Are Descendants of at Least 3 Ancient Human Groups: Study 3Health News:Researchers Discover How Bacteria Resist Antibiotics in Hospitals 2Health News:Researchers Discover How Bacteria Resist Antibiotics in Hospitals 3Health News:Math model designed to replace invasive kidney biopsy for lupus patients 2Health News:Blue Shield of California Foundation Awards $5 Million in Third-Quarter Grants 2Health News:Stress Less with the Hyland's 5-Day Stress Challenge 2
... to this new research on mountain biking it is observed ... from University Hospital in Innsbruck, Austria,// presented his findings of ... extreme mountain bikers and 30 non-bikers took part in the ... more than two hours a day, six days a week, ...
... effective utility tool to the field of medicine. An ... about their treatment. The days when doctors told you ... expect to participate in the decision-making process. But sometimes ... messages and new research comes up all the time. ...
... are more likely to suffer from behavioural problems, a ... growth hormone not only boosted growth in children,// but ... ,Lead researcher Dr Derick Beens, professor of ... said: "We believe this work demonstrates that all very ...
... has always been an ongoing argument regarding the do's and ... suggest a new and better way through the dieting controversy.// ... fashion being the 'low carb' approach - for many decades ... at the 'no diet' women's retreat Green Mountain in the ...
... events in detail, older people recall more about thoughts, ... age - some researchers believe that it deteriorates,// others ... Psychologists in Toronto have been comparing how people of ... ,They studied a group of 15 younger ...
... is better than conventional treatment for managing asthma ... of immune cells known eosinophils increase// in the ... at how targeting this build up of eosinophils ... an asthma attack. ,The conventional treatment ...
Cached Medicine News:
(Date:9/17/2014)... , Sept. 17, 2014 BRIC Biopsy Devices ... GlobalData,s new report, "BRIC Biopsy Devices Market Outlook ... Biopsy Devices market. The report provides value, in millions ... (in US dollars) within market segments - Biopsy Guns ... Fine Aspiration Needles (Disposable and Reusable Fine Aspiration Needles) ...
(Date:9/17/2014)... 17, 2014 The ambulance equipment ... decade due to the recession, an unstable ... advancements. This BCC Research report analyzes present ... the ambulance and emergency medical services equipment ... hemorrhage control devices, equipment used for burn ...
(Date:9/17/2014)... 2014 /PRNewswire-iReach/ -- ChemImage announced today the ... in the development of imaging technology used ... and diseased tissue that minimizes the learning ... lowers surgical costs and potentially enhances patient ... The clinical and scientific teams at ...
Breaking Medicine Technology:BRIC Biopsy Devices Market Outlook to 2020 2BRIC Biopsy Devices Market Outlook to 2020 3Ambulance and Emergency Equipment: Global Markets 2Ambulance and Emergency Equipment: Global Markets 3Ambulance and Emergency Equipment: Global Markets 4Patient Outcomes Improve When Molecular Chemical Imaging Technology Is Used to Aid Robotic Surgical Procedures, According to New White Paper 2
... , , DURHAM, N.C., Jan. 8 Oxygen ... common stock has been approved for listing on the NASDAQ ... to the NASDAQ is a very important milestone for our ... listed on the NASDAQ provides us with greater visibility for ...
... , , , FARMINGDALE, N.Y., Jan. ... of minimally invasive ultrasonic medical device technology, which in Europe ... other acute health conditions, has entered into a new, three ... in Riyadh, Kingdom of Saudi Arabia, for the distribution of ...
Cached Medicine Technology:Oxygen Biotherapeutics, Inc. Announces Approval for NASDAQ Listing 2Misonix Announces New Distribution Agreement for Kingdom of Saudi Arabia 2Misonix Announces New Distribution Agreement for Kingdom of Saudi Arabia 3
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
Medicine Products: