Amneal Pharmaceuticals

Amneal Pharmaceuticals, Inc. is an American publicly traded generics and specialty pharmaceutical company. The company is headquartered in Bridgewater, New Jersey.[2]

Amneal Pharmaceuticals
Public
Traded asNYSE: AMRX (Class A)
Russell 2000 Component
Founded2002 (2002)[1]
Founders
  • Chirag Patel, Ph.D.
  • Chintu Patel, Ph.D.
Headquarters
Bridgewater, New Jersey
Number of locations
Manufacturing plants in Branchburg, East Hanover and Piscataway, NJ; Brookhaven and Hauppauge, NY, India and Ireland; & Distribution/Commercial Operations in Glasgow, KY[1]
ProductsGeneric and specialty pharmaceuticals; biosimilars
Revenue $US $1.6 billion (2019)
Number of employees
>6,000 [1]
Divisions
  • Generics
  • Specialty Pharma
Websiteamneal.com

History

Amneal Pharmaceuticals was founded in 2002 by brothers Chirag and Chintu Patel. The company manufactured its first Rx product in 2005 and received its first ANDA approval in 2006.[3]

In 2007, the company acquired five divested drugs from Mylan which Mylan was forced to sell as part of their acquisition of the generics unit of Merck KGaA.[4] At this time, the company was noted as being a private company based in Paterson, New Jersey.[4]

After the 2007 acquisition of Akyma Pharmaceuticals, a Glasgow, Kentucky-based regional distributor, Amneal launched its own product label.[5]

In 2008, the company expanded into India with the development of an R&D Centre in Gujarat.[6] Continued expansion in the United States occurred between 2010 and 2016 in New Jersey, New York and Kentucky.[7][8] As of 2017, the company had grown much of its physical footprint and product base through a series of acquisitions, including the acquisition of assets from Pfizer, Actavis and Warner Chilcott.[3]

In 2018, Amneal Pharmaceuticals LLC merged with Impax Laboratories, Inc. to form Amneal Pharmaceuticals, Inc. Shares of newly public AMRX began trading on the NYSE on May 7, 2018.[9]

Concurrent with the Impax merger, Amneal acquired Gemini Laboratories for $117 million, including Unithroid, Gemini’s lead product for treating hypothyroidism.[10]

In December 2019, Amneal announced it had entered into an agreement to acquire a majority interest in AvKARE, a private label provider of generic pharmaceuticals in the US federal agency sector. Under the agreement, AvKARE would continue to operate as an independent subsidiary of Amneal. [11]

As of June 2020, co-founders Chirag and Chintu Patel served as co-CEOs of the company, while Paul Meister served as chairman.[12][13]

Formation of Amneal Pharmaceuticals Inc

In 2018, Amneal Pharmaceuticals LLC merged with Impax Laboratories, Inc. to form Amneal Pharmaceuticals, Inc. The FTC described the merger as having a value of US$1.45 billion, and required the companies to divest several marketed products and development projects as a condition of the approval.[14] The merger was completed in May 2018, with shares of IPXL ceasing trading on NASDAQ on May 4 and shares of AMRX commencing trading on the NYSE on May 7.[15] 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.[16]

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.[17]

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.[18]

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.[18]

The Impax Specialty Pharma Division has developed one 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.[19]

Regulatory and 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.[20] 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.[21][22]

In March 2011 several wholesale lots of the company's 200 mg fenofibrate capsules were recalled due to metal contamination and variable dose weight.[23][24] Impax announced the resolution of its May 2011 FDA warning letter for its Hayward, CA facility on September 8, 2015.[25]

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References
  1. https://www.amneal.com/about/our-story/amneal-at-a-glance/
  2. "Amneal at-a-glance". Amneal Pharmaceuticals. Retrieved July 26, 2019.
  3. "Founded by 2 Gujaratis, US drug major Amneal eyes speciality biz in India". Business Standard. November 14, 2017.
  4. Sabatini, Patricia (September 28, 2007). "Drug maker selling assets to win OK for deal". Business. Pittsburgh Post-Gazette. Retrieved June 23, 2018 – via Newspapers.com (Publisher Extra).
  5. "With technology, research muscle, Amneal looks to make its mark". Drug Store News. September 24, 2007.
  6. "Amneal Pharmaceuticals Completes Acquisition Of Liquid Form Generic Pharmaceuticals Manufacturing Plant". Pharmaceutical Online. January 4, 2008.
  7. "Amneal Pharmaceuticals Undergoing $60 Million Expansion". Patch. July 17, 2013.
  8. "Amneal Pharmaceuticals to expand in Glasgow". Louisville Business First. May 11, 2010.
  9. "Amneal Pharmaceuticals, Inc. (AMRX)". SeekingAlpha. March 2, 2020.
  10. "Newly Merged Amneal Pharmaceuticals to Push into the Biosimilar Space". BioSpace. May 10, 2018.
  11. "Amneal to purchase majority interest in AvKARE for $340M". NJBIZ. December 10, 2019.
  12. "Paul Bisaro vaulted now-struggling Amneal to top generics ranks—now, he and his handpicked CEO are out". Fierce Pharma. August 5, 2019.
  13. "Amneal co-founders back as co-CEOs; executive chairman, CEO resign". ROI-NJ. August 6, 2019.
  14. "Amneal And Impax Complete Business Combination". Biosimilar Development. May 7, 2018.
  15. "How $6 billion generic drug company merger could affect this East Bay city and Roche". San Francisco Business Times. May 9, 2018.
  16. "Form 10-K Impax Laboratories, Llc". SEC.gov. March 1, 2018.
  17. "Impax Completes Acquisition Of Tower Holdings, Inc. And Lineage Therapeutics Inc" (Press release). Hayward, California: Impax Laboratories, Inc. March 10, 2015. Archived from the original on October 26, 2015. Retrieved October 20, 2015.
  18. "Impax 2014 Annual Report" (PDF). Archived from the original (PDF) on October 23, 2015. Retrieved October 20, 2015.
  19. "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. January 8, 2015. Archived from the original on October 22, 2015. Retrieved October 20, 2015.
  20. "Purdue Pharma L.P. Announces Agreement to End OxyContin® Patent Lawsuit with IMPAX Laboratories" (Press release). Purdue Pharma. April 2, 2007. Archived from the original on July 22, 2010. Retrieved April 29, 2013.
  21. "Impax Labs. Introduces Oxymorphone Hydrochloride Extended-Release Tablets". RTTNews. January 4, 2013. Archived from the original on January 10, 2013. Retrieved February 15, 2014.
  22. Larson, Erik (April 2, 2007). "Purdue, Impax Settle Oxycontin Litigation". Law360. LexisNexis. Retrieved February 15, 2014.(registration required)
  23. "Warning Letter". Inspections, Compliance, Enforcement, and Criminal Investigations. Food and Drug Administration. May 31, 2011. Archived from the original on December 23, 2011. Retrieved February 15, 2014.
  24. Miller, George (June 7, 2011). "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 February 15, 2014. Retrieved February 15, 2014.
  25. "Impax Announces Resolution of FDA Warning Letter Related to its Hayward Manufacturing Facility" (Press release). Hayward, California: Impax Laboratories, Inc. September 8, 2015. Retrieved May 18, 2019.
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