Our constant task is to contribute to the good health of people by supplying them with safe, laboratory-tested, effective medicinal products that are accessible to every patient. We ensure patient safety with respect to our products by using advanced technologies and systems and high standards of Good Manufacturing Practice (GMP).
Good Manufacturing Practice (GMP) describes the standard that a drug manufacturer must meet in its manufacturing processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
Every manufacturer of medicines destined for the EU market, wherever they are in the world, must comply with GMP requirements.
GMP ensures that medicines:
- are of consistently high quality;
- are fit for their intended use;
- meet the requirements of the marketing authorisation or clinical trial authorisation.
One of the first in the sector to adopt GMP standards in its practice, Chemax Pharma has invested several decades to achieve and maintain the desired capacity and to make the manufacture of pharmaceutical products not only a fundamental but also the most promising activity in its business mix.
Spread over an area of more than 2000m2, the company’s three-storey manufacturing campus is equipped with fully automated and high performance machinery that generate a variety of formulations of active substances, pharmaceuticals and nutraceuticals on a daily basis.
Today, Chemax’s portfolio exceeds 130 different pharmaceutical products, and some of them occupy leading positions in their market segment.
More than 220,000 units of various pharmaceutical dosage forms are produced every day under the strict supervision of control chambers and readers that track every production cycle and ensure the compliance of the company’s pharmaceutical products with approved parameters and procedures. Thus, adherence to high quality and GMP standards continues to be among the key priorities in this portfolio.
Chemax Pharma ensures the high standard of its products and services by implementing a modern and continuously improving quality management system, which is certified by the competent authority of the Republic of Bulgaria and operates in accordance with the requirements of modern Good Manufacturing Practices in Pharmacy (cGMP) in the European Union.
The concept of quality assurance is fundamental to the company’s policy and is based on the fundamental understanding that the sustainable maintenance of the high standard of the products and services produced requires the implementation of a set of tools and measures, mainly of a preventive nature, developed on the basis of a thorough knowledge of the company’s processes and the quality standards in the industry.
The quality assurance system at Chemax Pharma covers the entire life cycle of manufactured products – from the creation and introduction of a product, through the selection and procurement of raw materials and supplies, production, quality control, approval, marketing and shelf-life maintenance of each batch of product manufactured, to the end of its use.
Quality control at the company is carried out in modern equipped laboratories for physicochemical, chromatographic and microbiological analyses, which are staffed by highly qualified specialists. All tests are carried out according to validated methods and in accordance with quality specifications validated and approved by the competent authorities.
The main priorities of the portfolio are:
- Incoming and ex-post control of all raw materials supplied for production;
- Incoming and ex-post control of all packaging materials supplied;
- Control of intermediate and bulk products obtained in the production process;
- Inspection of manufactured products prior to release to the market;
- Control of manufactured products within shelf life;
- Monitoring the cleanliness of the production environment, feed systems and equipment;
- Testing samples of new raw materials, finished materials and products;
- Development and validation of analytical test methodologies, etc.
Chemax Pharma is a pharmaceutical manufacturer and holder of 45 marketing authorisations for medicinal products in Bulgaria and more than 30 marketing authorisations abroad, which include prescription and non-prescription medicinal products. Strictly adhering to the provisions of current legislation on a national and European level, the maintenance of records requires highly expert work, which is carried out by the Regulatory Affairs department.
Responsibilities of the portfolio include:
- generation and keeping of documentation for the granting and renewal of marketing authorizations for all of the company’s medicinal products for the country and abroad;
- notifications for new food supplements;
- registration and price updates;
- regulatory expertise on packaging and promotional materials.
Despite the dynamic changes in the pharmaceutical industry’s legal regulations, the key priority of the portfolio is responsible patient information, in continuation of the company’s core mission – caring for people’s health and well-being.
Whether it is an active substance or a medicinal product, we take care, respect and precision to deliver a high quality, maximum effectiveness and safe product to the market. That is why our first advertisement has always been the satisfaction and testimonials as feedback from our customers, long-standing partners and specialists in the field of medicine and pharmacy.
For this connecting thread between patients and our medicines, we rely on our teams of medical and sales representatives, as well as all the employees in Marketing and Sales, who make sure that the various therapeutic groups of doctors and pharmacists are well informed and that the medicines are distributed in the country.
We market our products through the extensive distribution network of the largest national pharmaceutical distributors with whom we have been trading for 30 years. We are also a trusted partner of most of the hospitals in the country. This ensures that every patient has access to our medicines.
And because we never forget that we deliver health, we believe that knowledge about it and the right choice of product for a particular patient should be obtained first and foremost from specialists with the necessary competence.
We are satisfied that we meet many of them every day, and we will continue to uphold their trust in the future.
After more than two decades of establishing itself as a trusted partner to a large number of pharmacies, hospitals and distributors in the country, the company is taking up the challenge in the external pharmaceutical markets.
By upholding its high standard of quality over the years, Chemax Pharma has won the respect of new European partners and in 2013 the first export of products was realized for a corporate pharmaceutical company, which entrusted it with the development and production of its new brand. The first, still successful, partnership outside the country was launched.
The company has thus carved out a new portfolio and continues to invest in its international business development. The strategic objectives are to promote innovative ideas in the form of pharmaceutical developments, some of which are protected by patents and utility models, and to expand the marketing of its pharmaceutical products on foreign markets under its own and third-party trademarks.
Chemax Pharma offers international business partnership opportunities in the following formats:
- Out-licensing of pharmaceutical products under the customer’s brand name (private label);
- Contract manufacturing of products outside the company’s portfolio.
If you are interested, contact our team:
As we witness the dynamic development of the pharmaceutical industry, we are aware that the function of medicines has long been limited to their intended purpose of treating the patient. At the heart of the company’s strategy to create new products is the aspiration to provide not only an alternative, but a pharmaceutical product generating additional benefits in terms of speed and effectiveness of action, comfort of intake, convenient and precise dosing or so-called: “SUPERGENERIC MEDICATIONS”.
For the development of this portfolio, the company relies on several key pillars:
- Introduction of the latest “drug delivery” technologies;
- Creating proprietary methods to accelerate action;
- Creating proprietary methods to increase the comfort of intake;
The advantages of these dosage forms include:
- homogeneous distribution of the active ingredient in oral intake, Avoidance of high local concentrations and irritation of the gastrointestinal tract;
- better pharmacokinetic parameters, rapid absorption;
- avoidance of high sodium concentrations.
For its scientific developments in the pharmaceutical sector, Chemax Pharma was nominated Innovative Company of the Year*, and our achievements for some specific products have been protected by patents and certified for utility models.
The rebuilding and modernization of the company’s new own facility, which includes high-tech production workshops, laboratories and warehouses, is completed.
First own brand
Iodseptadone® – appears to launch a whole new series of branded medicinal products and food supplements. In the same year, Chemax Pharma was accepted as a regular member of the Bulgarian Chamber of Commerce and Industry.