Alfasigma USA, Inc. (''formerly'' Pamlab) is an American
medical food
Medical food is food that is specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States, it was defined in the Food and Drug Admin ...
company, and a division of
Alfasigma Group, of
Bologna
Bologna ( , , ; ; ) is the capital and largest city of the Emilia-Romagna region in northern Italy. It is the List of cities in Italy, seventh most populous city in Italy, with about 400,000 inhabitants and 150 different nationalities. Its M ...
, Italy.
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.
In early 2013, Pamlab was purchased by
Nestlé
Nestlé S.A. ( ) is a Swiss multinational food and drink processing conglomerate corporation headquartered in Vevey, Switzerland. It has been the largest publicly held food company in the world, measured by revenue and other metrics, since 20 ...
Health Science.
In December 2016, Pamlab was purchased by Alfasigma Group of
Bologna
Bologna ( , , ; ; ) is the capital and largest city of the Emilia-Romagna region in northern Italy. It is the List of cities in Italy, seventh most populous city in Italy, with about 400,000 inhabitants and 150 different nationalities. Its M ...
, Italy.
Legal actions
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.
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".
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".
A class action related to the VSL#3 scandal was recently opened in the USA.
Products
Alfasigma USA, Inc. produces
medical food
Medical food is food that is specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States, it was defined in the Food and Drug Admin ...
s for people with
diabetic peripheral neuropathy, early memory loss/
Alzheimer's
Alzheimer's disease (AD) is a neurodegenerative disease and the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems wit ...
,
high-risk pregnancy
A high-risk pregnancy is a pregnancy where the gestational carrier or the fetus has an increased risk of adverse outcomes compared to uncomplicated pregnancies. No concrete guidelines currently exist for distinguishing “high-risk” pregnancies ...
,
depression, and other medical conditions.
Some of Alfasigma USA's products include the following:
*
VSL#3
*
Deplin
Levomefolic acid (INN, also known as L-5-MTHF, L-methylfolate and L-5-methyltetrahydrofolate and (6''S'')-5-methyltetrahydrofolate, and (6''S'')-5-MTHF) is the primary biologically active form of folate used at the cellular level for DNA reproduc ...
*
Metanx
Metanx is a prescription medical food made by Alfasigma that contains L-methylfolate (as Metafolin, a calcium salt of vitamin B9), methylcobalamin (vitamin B12) and pyridoxal 5'-phosphate (vitamin B6). It is a vitamin B supplement. Metanx is i ...
*
Cerefolin
*
Cerefolin NAC
* Neevo DHA
* Proxeed Plus
* Colief
* Carnitine Bulk Ingredients
See also
* Nestlé Health Science
*
Medical Food
Medical food is food that is specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone. In the United States, it was defined in the Food and Drug Admin ...
References
External links
*
Alfasigma USA Human Resources
Nestlé brands
Food manufacturers of the United States
Medical and health organizations based in Louisiana
Medical food
Covington, Louisiana
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