Zinc Oxide Pharma-GMP
Zinc Oxide Pharma-GMP is a range of high purity zinc oxide products for use as API and excipient in pharmaceutical, veterinary and persona! care applications. The Zinc Oxide Pharma-GMP products are the world’s first and only zinc oxides covered by an official GMP certificate and CEP. Ali products further meet the specifications of the European (EP) and United States (USP) Pharmacopoeia monographs for zinc oxide.
Official GMP certificate and US FDA inspected
The Zinc Oxide Pharma-GMP products are manufactured in compliance to ICH-Q7 and EU Part Il GMP requirements for APls. This ensures the highest level of quality assurance and full compliance to the EU’s Falsified Medicine Directive (FMD).
The production facility for Zinc Oxide Pharma-GMP products in The Netherlands is registered as API manufacturer (reg.# 5738 API) and was awarded with an official GMP certificate by the Dutch authorities IGZ1 (Cert.# NL/H 151007135).
The facility is also registered with the US FDA (FEI# 3004732851) and successfully passed the FDA inspection in November 2014.
World’s first CEP certificate for zinc oxide
The Zinc Oxide Pharma-GMP products are the world’s first and only zinc oxide products that are covered by a Certificate of Suitability (CEP) issued by EDQM2
Ensuring maximum safety and efficacy
Zinc oxide Pharma-GMP is used in pharmaceutical and persona! care products for many purposes, such as skin healing and the prevention and treatment of skin rashes and irritation.
ln veterinary applications the Pharma-GMP products are used as medicine in pure form or as active substance in medicated premixes.
To ensure maximum efficacy and safety when using zinc oxide in topical applications, several options are included in Everzinc’s Pharma-GMP products that go further than the standard EP and USP monograph specifications. The se include tighter lead (Pb) specifications and products that are virtually free of metallic zinc.