Pamlab

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Alfasigma USA, Inc. (formerlyPamlab) is an American medical food company, and a division of Alfasigma Group, of Bologna, Italy.

Contents

Alfasigma's base of operations is located in Bedminster, New Jersey.

History

The 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]

Alfasigma 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

Alfasigma 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:

See also

References

  1. ↑ "Our History". Pamlab. Retrieved 2016-03-24.
  2. ↑ "Nestle buys U.S. medical foods firm Pamlab". Reuters. 26 February 2013. Retrieved 2016-03-24.
  3. ↑ "Alfasigma Expands Footprint" (PDF). 13 January 2017. Archived from the original (PDF) on 22 December 2018. Retrieved 18 July 2017.
  4. ↑ 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.
  5. ↑ "De Simone v. VSL Pharmaceuticals, Inc. et al, No. 8:2015cv01356 - Document 927 (D. Md. 2019)". Justia Law. Retrieved 2019-09-01.
  6. 1 2 "Class Action" (PDF).
  7. ↑ 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.
  8. ↑ "Class Action Accuses Pharma Companies of Secretly Reformulating VSL#3 Probiotics Product". www.classaction.org. 26 July 2019. Retrieved 2019-09-01.


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