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发布日期:2021年06月24日


Pharmaceutical & Food


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GMP License

WORLD’S FIRST

EverZinc Canada (GHC) was awarded the world’s first Good Manufacturing Practice (GMP) License to manufacture and sell pharmaceutical grade zinc oxide (USP) serving as an Active Pharmaceutical Ingredient (API). For years a much sought after product by pharmaceutical companies, EverZinc Canada’s (GHC) GMP licensed zinc oxide has now become the new standard for the industry. The license has been granted by the Canadian Government’s Health Canada Products and Food Branch Inspectorate.

INTERNATIONAL EQUIVALENCE

EverZinc Canada’s (GHC) USP line of zinc oxides conforms to all BP, EP and JP specifications. EverZinc Canada’s (GHC) GMP License is the equivalent to the standards established in the EU under ICH Q7, rendering EverZinc Canada (GHC) eligible to export its GMP Licensed zinc oxide to the EU in accordance with Article 46b(2)(b) of Directive 2001/83/EC regarding active substances for Medicinal Products for Human Use.

OUR PURIFICATION METHODS

EverZinc Canada (GHC) also makes very pure zinc oxides for the food additives business adhering to the strictest Food and Chemical Codex regulations. Our purification method can lower impurity levels in the zinc oxide in order to make pharmaceutical and food grades with maximum lead levels of 10 ppm and 5 ppm. For very special orders, EverZinc Canada (GHC) can manufacture zinc oxide with lead levels as low as 1 ppm.

VIEW CERTIFICATIONS


CEP Certification
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On July 4, 2018, the European Directorate for the Quality of Medicines and Healthcare (EDQM) granted EverZinc Canada (GHC) a CEP – Certificate of Suitability for its line of pharmaceutical grade zinc oxides as they relate to Active Pharmaceutical Ingredients (API’s) and excipients.

The CEP granted to the Saint Hyacinthe, Quebec facility is yet another milestone, and follows EverZinc Canada (GHC) having been the world’s first Good Manufacturing Practice (GMP) licensed zinc oxide manufacturer.

The combination of EverZinc Canada’s (GHC) CEP Certificate and its GMP License will serve to assure customers both in Europe and around the world, that EverZinc Canada (GHC) will provide the best possible zinc oxide for the registration of their products under EU Legislation.

The certificate is granted according to the provisions of Directive 2001/83/EC and Directive 2001/82/EC and any subsequent amendments and the related guidelines.

VIEW CEP CERTIFICATION


Zinc Oxide Grades

Zinc oxide grades required for API and Dietary Supplement uses are identified by the USP moniker. Food Additive and Fortification grades are identified using the FCC moniker. EverZinc Canada (GHC) differentiates its various grades for these markets by the maximum contained limit of lead in parts per million. USP and FCC grades are identified as a 5 (maximum 5 ppm lead contained), 1 (maximum 10 ppm lead contained) and 2 (maximum 20 pm contained). For instance, we recommend our CR-4 USP 1 for most dietary supplement customers. It is EverZinc Canada’s (GHC) CR-4 powder grade containing no more than 10 parts per million (ppm) of lead.