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, GHC’s 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.
GHC’s USP line of zinc oxides conforms to all BP, EP and JP specifications. GHC’s GMP License is the equivalent to the standards established in the EU under ICH Q7, rendering 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.
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, GHC can manufacture zinc oxide with lead levels as low as 1 ppm.
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. 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 GHC’s CR-4 powder grade containing no more than 10 parts per million (ppm) of lead.