Since 1998, Alkaloid Joint Stock (AD) Company implemented an investment cycle in approximate value of around 60 million euros. These funds were mainly used in the pharmaceutical sector.
In 2002 the Company finished the construction of the new factories for hard dose forms (with capacity of 2 billion dose units annually) and factory for semi-synthetic cephalosporin (with capacity of 200 million capsules and 3,5 million bottles of dry powder for oral suspension).
All capacities are constructed to fully comply with the European DPP standards (ISO 8 Class, D Class, 100000) certified by the TK3 Swiss consultancy company, member of the Thyssenkrupp group and are evaluated as state of the art technology.
The production capacity on annual level, functioning in two shifts, is as follows:
- 4,6 million ampoules of 1 ml, or 23,6 million ampoules of 2 ml or 14,2 million ampoules of 5 ml or 2 million ampoules of 10 ml;
- 4 million bottles of eye drops;
- 6 million suppositories;
- 12,6 million tubes of ointments, creams and gels;
- 800,000 bottles of solutions for external administration.
The overall production program of the pharmaceutical products of Alkaloid Pharmaceuticals is consisted of the following pharmaceutical forms:
- Oral hard dosage forms: Tablets - conventional and modified release, film-tablets, coated tablets, sub-lingual tablets, capsules, dry powder for oral suspension.
- Liquid dosage forms for oral administration: Solutions for oral administration, syrups, suspensions.
- Topical preparations: Ointments, creams, solutions, gels, sprays, vaginal pessaries, suppositories.
- Sterile dosage forms: Parenteral small-volume, eye drops, ointments for eyes.
Besides the capacities for manufacturing finished pharmaceutical products, Alkaloid-Pharmaceuticals has also facilities for extraction of opioids which include production of morphine and its derivatives as pharmaceutical raw materials.
The project costs for construction and start of operation of the new facilities for manufacturing hard dosage forms and semi-synthetic cephalosporins, which were part of the Alkaloid AD Skopje "Entry on the World Market" Project were 35 million euros.
The convertible loan which the company obtained from the international financial institutions (European Bank for Reconstruction and Development and the International Financial Corporation) was 17.400.000 euros and is fully repaid at the beginning of 2004.
Section for packing of drugs, ampoules production line and solutions for oral administration line
Taking care for quality production process, Alkaloid built and equipped a section for packing of drugs in compliance with the Good manufacturing practice norms. The Section is equipped with two new lines: Line for packing hard forms (tablets, dragées and capsules) which is presently used for packing of around 50 products of the Pharmaceutical program with maximum capacity of 200 individual boxes per minute. The ampoules packing line is used for packing all types of ampoules of the Pharmaceutical program and has a maximum capacity of 30.000 ampoules per minute. The total value of this investment is around 4.5 million euros.
In order to increase the automation level in the production process, Alkaloid installed new line for dosing, closure, labeling and packing of solutions for oral administration in the total value of 600.000 euros.
The strict norms of good production practice require compliance to regulations that are of utmost importance for smooth and highly sophisticated ongoing of the drugs manufacturing process.
In the frames of the investment project for new facilities for drugs packing, Alkaloid also adapted new premises for storing semi-products (intermediaries) that meet the highest standards for working in pharmaceutical companies. This additional investment, worth around 600.000 euros, contributed extensively to the speed and efficiency in the production process so that the present stock of semi-products is being prepared for various markets in accordance with the different demands and needs.
Quality assurance and control of the drugs
The primary care and the focus of the entire work of the Alkaloid-Pharmaceuticals is focused towards providing high quality product that will completely meet the needs of the patients. For this purpose, the company allocated significant investment funds in the segments of control and quality assurance of the drugs.
Worth mentioning is the investment in microbiological laboratory that has enormously improved the process of pharmaceutical control of drugs. There Alkaloid invested around 1.2 million euros. Additional 500.000 euros were invested in new chemical laboratory for control of the intermediary products and finished pharmaceutical products, in accordance with the GMP/DPP standards in force. It includes monthly warehouse for chemicals constructed in accordance with the PP project, with special safety cabinets for flammable materials, space for stability testing, central weighing facility, physical-chemical laboratory, instrumental laboratory for chromatography tests, separate for spectrum-photometry, solubility testing as well as premises for documentation processing, fully equipped with highly sophisticated instruments and equipment produced by world brand names.