Impax Laboratories
 | |
| Traded as | NASDAQ: IPXL |
|---|---|
| Founded | (1995) |
| Founder | Charles Hsiao, Ph.D. and Chungchiang Hsu, Ph.D. |
| Headquarters | Hayward, California |
Number of locations | Manufacturing plants in Hayward, CA; Middlesex, NJ; and Taiwan |
Key people | G. Fredrick Wilkinson serves as President and CEO since 2014 |
| Products | Generic and specialty pharmaceuticals |
| Revenue | est. $596 million (2014) |
Number of employees | Over 1,000 employees worldwide |
| Divisions | Generics and Specialty Pharma Divisions |
| Website |
impaxlabs |
Impax Laboratories, Inc., a publicly traded company listed on the NASDAQ Stock Market LLC under the symbol, “IPXL”, is a specialty pharmaceutical company focused on developing, manufacturing and marketing generic and branded products. The company is headquartered in Hayward, California, and has additional offices and facilities in New Jersey, Pennsylvania and Taiwan, R.O.C.[1]
History
The company’s predecessor entity, privately held Impax Pharmaceuticals, Inc., was founded in 1995. Publicly traded Global Pharmaceutical Corporation and Impax Pharmaceuticals, Inc. completed a reverse merger, forming Impax Laboratories, Inc. on December 14, 1999.[2]
The merger combined the advanced drug delivery systems developed by Impax Pharmaceuticals through its research and development capabilities with Global Pharmaceutical’s sales, marketing and distribution capabilities.[3]
Mergers and acquisitions
In March 2015, Impax completed its acquisition of Tower Holdings, Inc. (including operating subsidiaries CorePharma LLC and Amedra Pharmaceuticals LLC), and Lineage Therapeutics Inc. In connection with the closing of the acquisition, Impax reshaped the operating and reporting structure of its two divisions into Impax Generics and Impax Specialty Pharma.[1]
Operations
Impax Generics includes the company’s legacy Global Pharmaceuticals business as well as the acquired CorePharma and Lineage Therapeutics businesses. Impax Specialty Pharma includes the legacy Impax Pharmaceuticals business as well as the acquired Amedra Pharmaceuticals business.[4]
Impax’s Generics Division focuses on a broad range of therapeutic areas, including products having technically challenging drug-delivery mechanisms or unique product formulations. In addition to developing solid oral dosage products, the company’s portfolio includes alternative dosage form products, primarily through alliance and collaboration agreements with third parties.[1]
The company’s Specialty Pharma Division is focused on the development and promotion, through the company’s specialty sales force, of proprietary branded pharmaceutical products for the treatment of Central Nervous System disorders and other select specialty segments.[1]
The Impax Specialty Pharma Division currently has one internally developed branded pharmaceutical product, RYTARY® (IPX066), an extended release oral capsule formulation of carbidopa-levodopa for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication, which was approved by the FDA on January 7, 2015.[5]
Facilities
Impax announced the resolution of its FDA warning letter for its Hayward, CA facility on September 8, 2015.[6]
Recalls
Several wholesale lots of Impax's 200 mg fenofibrate capsules were recalled in March 2011.[7][8]
Litigation
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.[9] 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.[10][11]
Corporate governance
In 2008, Charles Hsiao was listed as President in an American manufacturers directory.[12] As of 2011, the roles of President and CEO were held by Chungchiang Hsu, according to an FDA Warning letter addressed to the company.[7]
References
Use YYYY-MM-DD format for publication dates
- 1 2 3 4 "Impax 2014 Annual Report" (PDF).
- ↑ "Impax Laboratories Inc. - Investor Relations - Investor FAQ".
- ↑ "Our Story - Impax Laboratories, Inc.".
- ↑ "Impax Completes Acquisition Of Tower Holdings, Inc. And Lineage Therapeutics Inc." (Press release). Hayward, California: Impax Laboratories, Inc. 2015-03-10.
- ↑ "Impax Pharmaceuticals Announce FDA Approval of RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules for the Treatment of Parkinson's disease" (Press release). Hayward, California: Impax Laboratories, Inc. 2015-01-08.
- ↑ "Impax Announces Resolution of FDA Warning Letter Related to its Hayward Manufacturing Facility" (PDF) (Press release). Hayward, California: Impax Laboratories, Inc. 2015-09-08.
- 1 2 "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.
- ↑ 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.
- ↑ "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.
- ↑ "Impax Labs. Introduces Oxymorphone Hydrochloride Extended-Release Tablets". RTTNews. 2013-01-04. Archived from the original on 2013-01-10. Retrieved 2014-02-15.
- ↑ Larson, Erik (2007-04-02). "Purdue, Impax Settle Oxycontin Litigation". Law360 (LexisNexis). Retrieved 2014-02-15.(registration required)
- ↑ "6857. IMPAX LABORATORIES INC". USA Major Manufacturers (8th ed.). Business Information Agency (BIACorp International). 2008. p. 443. ISBN 9781418770877. Retrieved 2014-02-15.