GMP certificates for Nystatin API and Dry Injections issued by SUKL
GMP is defined as that part of Quality Assurance which ensures that pharmaceutical products are consistently produced and controlled to the quality standards appropriate to their intended use.
On the basis of periodically GMP inspection carried out by State Institute for Drug Control (SUKL), as competent czech authority were issued for VUAB Pharma a.s.:
a) GMP Certificate for manufacture of Nystatin API
b) GMP Certificate for manufacture of Dry injections
FDA approvals for Nystatin
In June 2000, VUAB received FDA approval to manufacture Nystatin API. This approval make it possible market Nystatin API in USA
Certificate for Suitability (CEP) for Nystatin
CEP stands for certification of suitability to the monograph of the European Pharmacopoeia. The role of a CEP is to certify the compliance of a material with the requirements laid down in the relevant monograph of the European Pharmacopoeia. Active pharmaceutical ingredients for which a CEP has been granted are suitable for use in medicinal products.
CEP can be used by the manufacturers of pharmaceutical products in their applications for marketing authorisation to demonstrate the compliance of the substance (API) used with the monographs of the European Pharmacopoeia