ISALTIS

Pharmaceutique

High quality mineral salts GMP certified

ISALTIS is developping and manufacturing high purity mineral salts, GMP certified, used as pharmaceutical active ingredients to treat mineral deficiencies such as calcium, magnesium or iron deficiency. We also produce antiseptic ingredients such as zinc undecylenate, and dermatological ingredients such as lithium gluconate.

Our APIs are produced at Giavudan-Lavirotte factory, which is GMP certified by the french ANSM, and FDA approved.

Our organic minerals have a high bioavailability, linked to their biomimetic nature. Our know-how consists in decorating the mineral with an organic vector of plant origin in order to increase its solubility and its bioavailability. These are “premium” or “third generation” mineral salts with high added value, both in their design and in their quality, and are adapted to the needs of our pharma customers.

 The efficiency of our APIs is proven by clinical studies.

Our key pharma ingredients are :

  • Calcium salts : calcium glucoheptonate and calcium glycerophosphate 
  • Magnesium: magnesium gluconate and magnesium glycerophosphate
  • Iron: ferrous gluconate (organic form highly tolerated by human metabolism, without side effects and tasting less pronounced than other forms)
  • Trace elements: Copper, zinc and manganese gluconates
  • Zinc undecylenate and undecylenic acid: anti-bacterial and anti-fungal agents
  • Lithium gluconate : topical active ingredient against atopic dermatitis
  • Potassium nitrate : for teeth hypersensitivity

QUALITY AND REGULATORY

Our APIs have necessary documentation for our customers to deposit market authorizations (MAA).

The list of available CEP can be checked on EDQM website :

https://extranet.edqm.eu/publications/recherches_CEP.shtml

Our updated GMP certificates are listed on the website of Eudra GMP :

http://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPCompliance.do

This documents as well as complete DMF/CTD dossiers can be obtained on demand, as well as the FDA related documents.

Our APIs are proposed under several pharmacopeias : PE, USP and BPC.

ISALTIS owns its own analytical laboratories for physico-chemical and microbiological analysis. They are able to perform our own heavy metals analysis.