Sep 5, 2013

Alkaloid successfully completes the UK MHRA inspection

The British Medicines and Healthcare Products Regulatory Agency (MHRA), having conducted an inspection in Alkaloid AD – Skopje’s manufacturing site for production of solid pharmaceutical forms – tablets in the Pharmaceuticals profit center, renewed for the second time the certificate of conformity with the principles of Good Manufacturing Practice (GMP), as defined in the guidelines of the European Union.

Furthermore, MHRA issued a new certificate for production of hard gelatin capsules and also for the manufacturing site of liquid pharmaceutical forms, for internal and external use, which Alkaloid AD – Skopje had previously obtained certificates for by the Drug Agency of the Republic of Bulgaria and the Public Agency for Medicinal Products and Medical Devices of the Republic of Slovenia.

This GMP-inspection and assessment of the pharmaceutical quality system by MHRA was carried out for the first time in several plants simultaneously. It is yet another confirmation of the highest European standards that Alkaloid AD – Skopje applies in its daily operations, and basis for obtaining and maintaining the marketing authorizations in the European Union.

Thus, Alkaloid AD – Skopje is confirmed as a highly professional manufacturer of pharmaceutical products by applying the most modern production technologies and business standards with a sole purpose – quality, efficient and safe medicinal products.