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Alfasigma USA, Inc. (formerly Pamlab) is an American medical food company, and a division of Alfasigma Group, of Bologna, Italy.
Alfasigma's base of operations is located in Bedminster, New Jersey.
History
editThe company entered the pharmaceutical industry in 1957, initially introducing prescription cough/cold products. In 1987, Pamlab was purchased by Samuel and Judith Camp.[1]
In early 2013, Pamlab was purchased by Nestlé Health Science.[2]
In December 2016, Pamlab was purchased by Alfasigma Group of Bologna, Italy.[3]
Legal actions
editAlfasigma USA, Inc. was sued by ExeGi Pharma LLC and the Italian inventor of probiotic VSL#3, Claudio De Simone, for making false advertising claims and ownership rights to VSL#3.[4][5][6]
According to court documents: "Defendant VSL Inc., and its licensees Alfasigma and Leadiant, having lost the right to sell the De Simone Formulation, decided to manufacture, market, and sell a different, inferior formulation (the “Fraudulent Formulation”) without conducting any tests to determine if the Fraudulent Formulation would be efficacious in any way".[6]
A scientific article published in Frontiers in Immunology concluded: "These discrepancies may have a major impact on patient safety and on the liability of doctors when they prescribe a probiotic formulation made with different processes at different production sites from the formulation, which generated the original evidence, without properly informing the patients".[7]
A class action related to the VSL#3 scandal was recently opened in the USA.[8]
Products
editAlfasigma USA, Inc. produces medical foods for people with diabetic peripheral neuropathy, early memory loss/Alzheimer's, high-risk pregnancy, depression, and other medical conditions.[citation needed]
Some of Alfasigma USA's products include the following:
- VSL#3
- Deplin
- Metanx
- Cerefolin
- Cerefolin NAC
- Neevo DHA
- Proxeed Plus
- Colief
- Carnitine Bulk Ingredients
See also
edit- Nestlé Health Science
- Medical Food
References
edit- ^ "Our History". Pamlab. Retrieved 2016-03-24.
- ^ "Nestle buys U.S. medical foods firm Pamlab". Reuters. 26 February 2013. Retrieved 2016-03-24.
- ^ "Alfasigma Expands Footprint" (PDF). 13 January 2017. Archived from the original (PDF) on 22 December 2018. Retrieved 18 July 2017.
- ^ Simone, C. De (2018). "Letter: what gastroenterologists should know about VSL#3". Alimentary Pharmacology & Therapeutics. 47 (5): 698–699. doi:10.1111/apt.14515. ISSN 1365-2036. PMID 29417631.
- ^ "De Simone v. VSL Pharmaceuticals, Inc. et al, No. 8:2015cv01356 - Document 927 (D. Md. 2019)". Justia Law. Retrieved 2019-09-01.
- ^ a b "Class Action" (PDF).
- ^ Trinchieri, Vito; Laghi, Luca; Vitali, Beatrice; Parolin, Carola; Giusti, Ilaria; Capobianco, Daniela; Mastromarino, Paola; De Simone, Claudio (2017-11-06). "Efficacy and Safety of a Multistrain Probiotic Formulation Depends from Manufacturing". Frontiers in Immunology. 8: 1474. doi:10.3389/fimmu.2017.01474. ISSN 1664-3224. PMC 5681494. PMID 29163538.
- ^ "Class Action Accuses Pharma Companies of Secretly Reformulating VSL#3 Probiotics Product". www.classaction.org. 26 July 2019. Retrieved 2019-09-01.
External links
edit- Official website
- Alfasigma USA Human Resources Archived 2015-05-04 at the Wayback Machine
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