Infrastructure for Development and Quality Control

DATA ABOUT RESPONDENT

Full name
Sonja Ugarković
Name of your institution
Alkaloid AD – Skopje, Pharmaceutical Chemical Cosmetic Industry
Institutions’s country
Republic of North Macedonia
Institution’s address
Blvd. Aleksandar Makedonski 12, 1000 Skopje, FYR of Macedonia
Are you responsible on behalf of the institution
Yes
Your position in the institution
  • Research Infrastructure Manager (administrative)
Your telephone number
+389 2 31 04 000
Your email address
sugarkovic@alkaloid.com.mk
Institution's website address
http://www.alkaloid.com.mk

GENERAL INFORMATION ABOUT RESEARCH INFRASTRUCTURE OR IMPORTANT RESEARCH EQUIPMENT

Research infrastrcture website
http://www.alkaloid.com.mk
Organisation / institution type of RI
  • Private

Main scientificdomain: Life sciences

Category: Other Life Sciences RI

Other scientific and technological domains served by RI
  • Life Sciences
RI type
  • Single-sited
Short description

Alkaloid AD is a pharmaceutical chemical cosmetic industry and generic producer of pharmaceuticals, existing since 1936. Institute for Development and Quality Control is organised within PC Pharmaceuticals, and covers activities which are performed during development of generic drug products- preformulation studies, formulation, process, analytical method development and transfer to industry.

The institute covers 1540 square meters of used area. It is equipped with newest laboratory and pilot manufacturing equipment, as well as highly sophisticated analytical instruments that enable the development of new modern forms of generic drugs implementing the latest advances in the field of pharmaceuticals.

The institute was officially launched in march 2009. The necessary funds were provided mostly from resources of Alkaloid AD and partly from allocated credit lines. The establishment of the Institute is actually an added value to the drugs in terms of development and introduction of new technologies and methods, maintenance of the quality, continuous improvement and meeting the strict reference demands of the European regulatory bodies.

OPERATION AND UPGRADE OF RESEARCH INFRASTRUCTURE AND OR IMPORTANT RESEARCH EQUIPMENT

Comment on cooperation
As for the main cooperation partners, the following are listed: Ss. Cyril and Methodius University in Skopje; Faculty of Medicine, Department of Preclinical and Clinical Pharmacology & Toxicology - Skopje; Faculty of Pharmacy, Skopje; Faculty of Mathematics and Natural Sciences, Institute for Chemistry, Skopje; Rudjer Boskovic Institute, Croatia

STAFF, INTERNAL USERS AND EXTERNAL USERS

FINANCE

SCIENTIFIC IMPACT

RESEARCH SERVICES PROVIDED TO USERS AND RESEARCHERS

Research services provided to users and researchers
In terms of the research infrastructure, there are two main laboratories organised within the institute: laboratory for preformulation studies and laboratory for method development and validation, equipped with HPLC instruments, UPLC, spectrophotometers, dissolution testing equipment, FTIR, morphology analysers, stability/ photo stability chambers etc. The area where the technological development take place has been furnished according to the cleanliness class ISO 8, and equipped mainly with laboratory equipment needed for producing solid dosage forms – lab fluid bed granulator, high shear mixer, blenders, in-process testing equipment, R&D tableting machine etc.

Entry created by Elke Dall on February 17, 2010
Modified on October 24, 2012