Wednesday, October 30, 2013

LIF’s medicines are gluten free

     “The patients with celiac disease in Santa Fe can use medicines produced by LIF without any problem” said Ph. Guillermo Cleti (LIF’s Director).
     LIF and ASSAL(1) have recently signed an agreement in which ASSAL will do the tests for gluten at LIF’s medicines.
     Thus, LIF has sent to ASSAL the different APIs(2) and excipients utilized to produce medicines.
     The results were negative in all APIs and excipients. That is why, all LIF’s medicines are gluten free.
     “The next step will be to add the phrase “gluten free” at the packaging and prospects” confirmed Guillermo Cleti.
     In May 2013, ANMAT(3) published a new regulation for medicines gluten free which includes: definitions and a guideline for the use of the term “gluten free” at medicines

Celiac disease and gluten
     Gluten is a protein present in wheat, oats, barley and rye.
     Celiac disease is an autoimmune disorder in the small intestine. Patients with celiac disorder present gluten intolerance.
     Symptoms: pain and discomfort in the digestive tract, chronic constipation and diarrhea, failure to thrive (in children), anemia and fatigue.
(1)ASSAL: Agencia Santafesina de Seguridad Alimentaria (Santa Fe’s Food Regulatory Agency)
(2) Active Pharmaceutical Ingredient
(3) ANMAT: Administración Nacional de Medicamentos, Alimentos y Tecnología Médica. (National Regulatory Agency for medicines, food and medical devices).


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