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Production


What we produce?

INBIOTECH is specialized in production, distribution, marketing and sale of high-quality generic medicinal products and nutraceutical products

Production of medicinal products

Production and control of solid non-sterile dosage forms is accomplished as contracted activity in some of the best factories and laboratories in Bulgaria with over 50-year history, as well as in renowned and leading factories and laboratories in countries of the European Union. All these factories and laboratories are certified and comply with all valid regulatory requirements. 


Modern production technologies for medicinal products

In the production process modern technologies and equipment are utilized, according to modern regulatory requirements. Also, in the production process all standards that guarantee manufacturing of high-quality, effective and safe medicinal products (e.g. GMP - Good Manufacturing Practice; ISO - International Organization of Standardization and others) are met.
Production
Pharmaceutical quality management system

Pharmaceutical quality management system


Quality management sysem for medicinal products & nutraceutical products

INBIOTECH, in addition to being Marketing Authorization Holder (MAH) of medicinal products, also is holder of Manufacturing Authorization for medicinal products for human use for certification/batch release for the market of non-sterile medicinal products, according to the valid EU laws. Also, INBIOTECH holds certificate for Good Manufacturing Practice (EU GMP), which certifies that manufacturing conditions are in accordance to the requirements of Directive 2003/94/EC. The company introduced and currently maintains Quality Control System that is in accordance with all regulatory requirements and standards. 

Contract manufacturing

At the business unit "Contract Manufacturing" of INBIOTECH work qualified specialists with over-20-year experience, as well as young specialists in contract manufacturing and quality control and assurance of medicinal products and nutraceutical products. 

INBIOTECH is partner in contract manufacturing and quality control agreements with manufacturing facilities and laboratories in Bulgaria, as well as in countries of the European Union.