Import substitution in practice is a high-quality domestic genetic in the segment of anti-asthmatic aerosols in the portfolio of the company “Micropharm”, LLC

The company “Micropharm” founded in 1992, since 2011 is part of the holding company “Unipharma”.

Kharkiv Production Company “Micropharm” is one of the leaders of the national pharmaceutical industry for the production of sprays and aerosols. At the moment, in the company's portfolio are medicines of various pharmacotherapeutic groups: for the treatment of upper respiratory tract diseases, antiasthmatic agents, local antiseptics, wound healing and anti-inflammatory drugs, which are manufactured using high-tech modern equipment using only high-quality raw materials and components from leading world manufacturers.

Based on the experience of highly qualified employees of the company “Micropharm” and on practical solutions of leading European companies, the company implemented a project for the complete reconstruction of the site for the production of anti-asthmatic drugs in 2015. The main objective of this project was not only to resume the release of drugs used in obstructive airway diseases, but also to optimize and improve the production process, paying special attention to the quality and accuracy of the dosage of the product.

As part of the modernization project, the production site was equipped with a new anti-asthmatic aerosol packaging line manufactured by Pamasol (Switzerland), the world leader in the production of aerosol equipment for the pharmaceutical industry, in particular for the packaging of drugs used in pulmonology.

The anti-asthmatic drug Salbutamol-NEO is produced on the semi-automatic Pamasol line, intended for the production of metered aerosols. The line consists of several automata:

1. The automatic machine for packing the product with the recirculation system, which doses the preset volume of the solution with a constant circulation of the semi-finished product, which guarantees the uniformity of the solution and the filling of the vials

2. The crimping machine has an oil-free version with a pneumatic action, which allows individual determination of the contact pressure.

3. The machine for dosing freon in oil-free version ensures high accuracy of dosing.

Salbutamol-NEO is a strategically important drug both for the company and for Ukrainian consumers. Therefore, in its production, quality is given special attention.

One of the important indicators of the quality of this drug are the confirmed indices of aerodynamic determination of fine particles (deposition of the allocated dose) and homogeneity of the delivered dose.

On the basis of the State Enterprise “Ukrainian Scientific Pharmacopoeial Center for the Quality of Medicines”, after analyzing the above indicators in comparison with the original drug, an opinion was obtained on their identity, which indicates the high quality of the drug produced in the new site.

The final stage of the site's modernization was the preparation of a whole package of documents: protocols, test certificates, operating instructions, as well as works on site qualification / validation, reporting and training. The site has been certified and meets all the requirements of Good Manufacturing Practice (GMP).

Due to the introduction of modern technologies and equipment, as well as the high qualification of the personnel, the company “Micropharm” is one of the few that offers the Ukrainian consumer high-quality domestic genie in the segment of anti-asthmatic aerosols.