FITOFARM is a pharmaceutical and cosmetic company with established reputation, which in the scope of its business performance as key pillar has the industrial production and sales of drugs, food supplements, medical devices, herbal, cosmetic and galenical products.
Today FITOFARM is successful manufacturing company which in aspect of technology advantages, market orientation and development strategy, continuously sustains the step with the current needs and highest standards for pharmaceutical operating. Also, it has fully commitment towards upraising its own brands and building up an image for FITOFARM in general, as well-known brand. Following this principle, the cosmetic line LEA developed from the early beginnings of company’s existence almost 25 years ago, has already become a well established brand on the market in Macedonia and abroad, lifted up to the level of most remarkable and famous one for FITOFARM.
FITOFARM is a company in full ownership of Mrs. Lenche Adziska, a specialist in pharmaceutical technology, which was founded in 1989. Since then, the company has a constant progress and development, reaching up a stage of a modern company with stable positioning on domestic and foreign markets. FITOFARM is present with its own product portfolio on the markets in Bulgaria, Turkey, Montenegro, Albania, Armenia, Azerbaijan, Bosnia and Herzegovina and Kosovo. FITOFARM has its own representative offices in Bulgaria, located in Sofia and in Italy, with location in Bologna.
After 20 years of intensive development, FITOFARM enters into investment cycle for starting a novel, especially important strategic phase – manufacturing of pharmaceutical dosage forms as part of non-sterile production of medicinal products, in respond to the actual market demands and also defining course perspectives, towards export-oriented production. Thus, a new facility was built up in compliance with the current GMP standards relevant for pharmaceutical industry. The new factory located in the industrial zone of Vizbegovo started to work in November, 2008 and since then operates on a functional level with full implementation of GMP principles. All production operations which are part of technology processes for manufacturing pharmaceutical dosage forms are approved by the Health Authorities – Bureau for medicines and Ministry of health in Macedonia covered also with valid GMP certificate. The facility has available area of 2000 m2 for primary and secondary manufacturing, warehouse and administrative offices.
In this moment, FITOFARM has 61 employees as total headcounts. 23 of them hold university degree in their educational background (specialists and bachelors of pharmacy, medical doctors and dentists, masters of biology sciences, engineers, economists etc.) applicable for the existing role profiles in the company. Human resources represent a crucial force for maintaining operation status of FITOFARM and also a milestone giving significant advantage for the company ahead of other competitors present on the market.
DEPARTMENTS / ORGANIZATIONAL STRUCTURE
Production facility of FITOFARM enables following performances:
– primary manufacturing,
– secondary manufacturing,
– quality control,
– storage and
of medicines, food supplements, medical devices, herbal and cosmetic products.
In accordance with the manufacturing license issued by the Ministry of health of Macedonia and Bureau for medicines, FITOFARM is allowed to manufacture following pharmaceutical dosage forms:
Liquid dosage forms for external and oral application: syrups, solutions, suspensions, drops, lotions, shampoos
Semi-solid dosage forms: creams, ointments, gels, pessaries and suppositories.
Besides above reffered forms, with manufacturing license are also covered following operations:
Packaging of solid pharmaceutical dosage forms (in bulk) in immediate and outer packaging (powders, granules, tablets and capsules)
Packaging of pessurised prepartiones (aerosols) and sterile forms for parenteral administration (ampoules, vials) in secondary packaging
Also, FITOFARM is licensed as industrial facility for manufacturing food supplements in accordance with the approval issued by the Food Agency of Macedonia.
Production area is divided into several separated, but functionally connected zones, which are organized in such manner to meet the GMP provisions for safe production of dosage forms assuring the quality, with pre-defined moving directiones for raw materials or supplies, finished products and personel.
The production facility is equipped with HVAC system designed to be compliant with cGMP, FDA requirements and ISO 14644. The HVAC system is consisted of 3 subunits: K1 and K2 enabling 10 to 25 air exchanges/h and K3 enabling 8 to 15 air exchanges/h; relative humidity in range of 30% to 65% and defined differential pressure (0Pa, +10Pa; +15Pa; +30Pa).
Also, the facility is equipped with system for production of purified water (ROCON E 500L), based on combination of 2 units (reverse-osmosis and electro-deionization). System has capacity of 500 L/h which is sufficiently to satisfy the needs for process water production compliant with monograph for Purified Water according to Ph. Eur.
RESEARCH AND DEVELOPMENT
FITOFARMS actively works on development of new and improvement of existing formulations for its finished products. In the R&D department is enrolled highly educated stuff, who continuously attain advanced trainings in order to apply most sophisticated technical and technological methods thus providing to be formulated products customized upon market needs in different countries and meet the requirements for quality, efficacy and safety in optimal time duration.
Formulation of new product starts with development and research phase in the R&D laboratory of FITOFARM, including preparation of different test-probes for trial purposes (analytical testings and stability studies) by which will be confirmed the final composition formula of finished product necessary for designing the pilot-production batch before transferring it to routine production.
Despite this, FITOFARM has in its portfolio also products from the categories – drugs and food supplements, which are supplied as in-bulk intermediates and further on only packed in facility of FITOFARM. Such activity is performed based on a license agreement with foreign companies upon established contract manufacturing business relationship. For such products, part of the stuff in R&D department is involved in proactive participation on projects with final goal – selecting the most suitable immediate packaging material and also, design of secondary packaging elements.
FITOFARM has in disposal its own laboratory for quality control and testing of all products from its portfolio. The lab is designed and constructed in compliance with the GLP requirements providing testing services for the routine production and R&D department.
Quality control department as consisting part of the organizational structure of FITOFARM is completely independent in its operating activities. In its competency are included:
quality control of all incoming raw materials and packaging elements
in-process control during inter-phase production
complete analysis of all finished products according to which the certificate of analysis is issued.
The Quality control department has a key role in decision making process which directly affect the product quality. Highly sophisticated and modern equipment along with the selective techniques implemented in routine testing and also, well experienced personnel engaged in the laboratory work, are guaranty for obtaining precise results upon performed analytical investigations.
Quality assurance in FITOFARM represents one of top priorities for the company and also for each one employed.
FITOFARM has established its own QA system providing GMP compliant production of pharmaceutical dosage forms. It is designed to support transparent performance of all activities irrespectively of the hierarchy level within organizational structure in order to improve interfacing between departments and company efficacy. Establishment of Quality system is a responsibility of QA department.
Quality system ensures continuous production under a strictly defined provisions which guarantee manufacture of finished products with consistent quality in accordance with the specifications approved in registration dossiers and valid monographs of relevant pharmacopoeias. Thus, the quality in all segments of operational performance is assured and consequently – on the market to be placed only products with quality, safety and efficacy profile meeting the customer expectations.
In FITOFARM, the quality is a part of company’s every-day-life, a part of a bussiness strategy and policy.
SALES/ MARKETING/ DISTRIBUTION
As part of the Department for Sales, Marketing & distribution, are included:
Medical Representatives – medical doctors, dentists and pharmacists engaged as field force to promote and proactively contribute in marketing campaigns for product portfolio of FITOFARM through-out direct contacts and visiting healthcare providers/practitioners in health institutions of primary, secondary and tertiary level
wholesale – organized in most-excellent equipped area, responsible for wholesaling of drugs, food supplements, medical devices, herbal and cosmetic products from FITOFARM’s portfolio supplying the pharmacies and other wholesalers in Macedonia using its own distribution chain.