Pharmaceutical quality control

Since 1998, Alkaloid AD Skopje has invested close to €60 million, mainly in the Pharmaceuticals Manufacturing Division.

In 2002 the company finished the new plant for solid dosage forms and the plant for semi-synthetic cephalosporins. It is located around 10 kilometres from the company’s headquarters in the western industrial zone in Gjorche Petrov.

With the quality of the production process in mind, in 2005, Alkaloid built and equipped a new department for packaging of drugs, compliant with the Good Manufacturing Practices (GMP) standards. The department has six automatic blister-pack lines and one strip-pack line for the packaging of Caffetin tablets.

As part of the investment in a new drug packaging plant, Alkaloid allocated and adapted a new warehouse for intermediates compliant to the highest performance standards for pharmaceutical companies. This additional investment brought huge advantages to the speed and efficiency of the manufacturing process. The existing reserves of intermediates are now prepared for different markets, depending on the demand and needs.

To further automate manufacturing, Alkaloid installed a new automatic line for dosage, sealing, labelling, and packaging of oral liquids.

In 2018, following a complete reconstruction of the facility, the company launched the semi-solid dosage forms plant compliant with the GMP requirements. It purchased and installed new equipment for production of eye and topical ointments and topical creams and gels.

In 2020 it launched a new drug packaging plant, equipped with two high-speed blister pack lines, increasing the packaging capacity by 25%.

A second automated liquid oral dosage line was installed in 2021, introducing the dosage of new volumes and a new type of packaging units.


Production Capacity

The Pharmaceuticals Manufacturing Division consists of the following production units:

- Manufacturing – solid forms

- Manufacturing – cephalosporins

- Manufacturing – liquids

- Manufacturing – semi-solid forms

- Packaging of drugs

- Production of pharmaceutical raw materials

All manufacturing lines for pharmaceutical dosage forms are equipped in full compliance with the European GMP standards.

The strict GMP norms require regulatory compliance, which is especially important for the smooth and highly sophisticated process of production of drugs.

The full pharmaceutical product line of the Pharmaceuticals Manufacturing Division consists of the following pharmaceutical forms:

  • solid oral dosage forms: conventional and modified-release tablets – film-coated tablets, dragees, capsules, and dry powder for oral suspension;

  • liquid oral dosage forms: oral solutions, syrups, and suspensions;

  • topical preparations: creams, ointments, solutions for external use, gels, and vaginal and rectal suppositories.

In addition to the pharmaceutical dosage forms plant, Alkaloid’s Pharmaceuticals Manufacturing Division also has an opioid extraction plant. It produces morphine and morphine derivatives as pharmaceutical raw materials.

The annual manufacturing capacity, produced in three shifts, is as follows:

  • 4 billion solid oral dosage forms;

  • 200 million tablets, 85 million capsules, 5 million bottles of dry powder for oral suspension, and 10 million individual packs of ready drugs, semi-synthetic cephalosporins as solid oral dosage forms;

  • 6 million vaginal and rectal suppositories;

  • 10 million tubes of ointments, creams, and gels;

  • 1.8 million bottles of solutions for external use;

  • 9 million bottles of oral solutions, syrups, and suspensions; 

  • 160 million individual boxes for packaging of drugs;

  • 10 tons of pharmaceutical raw materials;