Impax Laboratories

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Impax Laboratories, Inc.
Traded as NASDAQIPXL
Industry Pharmaceutical, chemical [1]
Headquarters Hayward, California[1]
Key people
  • Chungchiang Hsu (President, CEO)[2]
  • Barry R. Edwards[1]
  • Larry Hsu[1]
Revenue est. $50-100 million (2008)[1]
Employees est. 200-499 (2008)[1]
Website impaxlabs.com

Impax Laboratories is an American pharmaceutical company headquartered in Hayward, California.[1][3][4]

Facilities[edit]

Following Food and Drug Administration inspections, Impax was asked on March 2, 2013 in a Form 483 to resolve 12 issues with its manufacturing facilities and processes.[5][6][7]

Production[edit]

In June 2011, IMPAX and a subsidiary of Teva Pharmaceutical Industries Ltd. entered into a strategic alliance agreement for controlled release pharmaceutical products.[8][9] Impax gained authorization to produce venlafaxine hydrochloride as of June 2011.[10] It is actively seeking approval of IPX066, an extended-release carbidopa/levodopa, as of March 2013.[11][12][13]

Recalls[edit]

Several wholesale lots of Impax's 200 mg fenofibrate capsules were recalled in March 2011.[2][14]

Litigation[edit]

Impax and DAVA Pharmaceuticals engaged in a legal dispute with Purdue Pharma over the patents and production of time-released oxycodone (OxyContin) until reaching an agreement in April 2007.[15] Another dispute with Endo Pharmaceuticals and Penwest Pharmaceuticals concluded with Impax gaining the right to begin producing extended-release oxymorphone through its Global Pharmaceuticals division as of 2013.[16][17]

Corporate governance[edit]

In 2008, Charles Hsiao was listed as President in an American manufacturers directory.[1] As of 2011, the roles of President and CEO were held by Chungchiang Hsu, according to an FDA Warning letter addressed to the company.[2]

See also[edit]

References[edit]

Use YYYY-MM-DD format for publication dates

  1. ^ a b c d e f g h "6857. IMPAX LABORATORIES INC". USA Major Manufacturers (8th ed.). Business Information Agency (BIACorp International). 2008. p. 443. ISBN 9781418770877. Retrieved 2014-02-15. 
  2. ^ a b c "Warning Letter". Inspections, Compliance, Enforcement, and Criminal Investigations. Food and Drug Administration. 2011-05-31. Archived from the original on 2011-12-23. Retrieved 2014-02-15. 
  3. ^ Seife, Charles; Rob Garver (2013-04-24). "Generic drugs aren’t necessarily the same". ProPublica (Salon). Archived from the original on 2013-04-25. Retrieved 2013-04-28. 
  4. ^ "ORA FOIA Electronic Reading Room > Impax Laboratories, Inc.". Office of Global Regulatory Operations and Policy. Food and Drug Administration. 2013-03-29. Retrieved 2013-04-28. 
  5. ^ "Impax Labs falls aftermarket on new FDA concerns". Bloomberg BusinessWeek. Associated Press. 2013-03-04. Archived from the original on 2014-02-15. Retrieved 2014-02-15. 
  6. ^ "Impax Labs plunges on new manufacturing problems". Bloomberg Businessweek. Associated Press. 2013-04-05. Archived from the original on 2014-02-15. Retrieved 2014-02-15. 
  7. ^ Palmer, Eric (2013-03-06). "Impax handed 12-page 483 at reevaluation". FiercePharma Manufacturing (Questex Media Group). Archived from the original on 2013-03-14. Retrieved 2014-02-15. 
  8. ^ "IMPAX and Teva Announce Strategic Alliance for Generic Controlled Release Products". The Free Library. 2001-06-27. Retrieved 2014-02-15. 
  9. ^ "Impax and Teva Announce Strategic Alliance for Generic Controlled Release Products" (Press release). Teva Pharmaceuticals. 2001-06-27. Archived from the original on 2014-02-15. Retrieved 2014-02-15. 
  10. ^ Harrington, Peter J. (2011). Pharmaceutical Process Chemistry for Synthesis: Rethinking the Routes to Scale-Up. John Wiley & Sons. p. 93. ISBN 978-0470922866. 
  11. ^ Carroll, John (2010-12-16). "Impax snares $186M deal from GSK on late-stage Parkinson's drug". FierceBiotech (Questex Media Group). Archived from the original on 2010-12-23. Retrieved 2014-02-15. 
  12. ^ "Impax Pharmaceuticals Announces Presentation of RYTARY(TM) (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data at the American Academy of Neurology 2013 Annual Meeting". BusinessWire. MarketWatch. 2013-03-19. Archived from the original on 2014-01-10. Retrieved 2014-02-15. 
  13. ^ "Impax Pharmaceuticals Announces Presentation of RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data at the American Academy of Neurology 2013 Annual Meeting" (Press release). Impax Laboratories. 2013-03-19. Retrieved 2014-02-15. 
  14. ^ Miller, George (2011-06-07). "Impax reveals warning letter related to drug recall Read more: Impax reveals warning letter related to drug recall". FiercePharma Manufacturing (Questex Media Group). Archived from the original on 2014-02-15. Retrieved 2014-02-15. 
  15. ^ "Purdue Pharma L.P. Announces Agreement to End OxyContin® Patent Lawsuit with IMPAX Laboratories" (Press release). Purdue Pharma. 2007-04-02. Archived from the original on 2010-07-22. Retrieved 2013-04-29. 
  16. ^ "Impax Labs. Introduces Oxymorphone Hydrochloride Extended-Release Tablets". RTTNews. 2013-01-04. Archived from the original on 2013-01-10. Retrieved 2014-02-15. 
  17. ^ Larson, Erik (2007-04-02). "Purdue, Impax Settle Oxycontin Litigation". Law360 (LexisNexis). Retrieved 2014-02-15. (registration required)

External links[edit]