- Our main activity consists of production and packaging of pharmaceutical products for human use in different forms:
– Solid dosage forms (tablets, coated tablets, film coated tablets, gelatin capsules)
– Liquid and semi-solid dosage forms (syrups, solutions, suspensions, creams, fats, gels, lotions, sprays, suppositories, vagitories)
– Sterile products (small-volume parenteral preparations, eye drops)
- Production process at Replek Farm plant is completed according to clearly defined procedures prescribed with Good Manufacturing Practice standards, in order to satisfy specification requirements according to which it has been registered and guarantee product’s quality, efficacy and safety.
- The factory covers an area of 3.522 m2. It is equipped with state-of-art technology that is continuously developed, upgraded and modernized.
- During the production process toxic materials are neither used nor produced.
Production facility consists of:
• Department for solid dosage forms (production and packaging area)
• Department for semi-solid and liquid dosage forms (production and packaging area)
• Confectioning Department (production and packaging area)
• Tampon zones, wardrobes, toilettes, restaurant for employees, ancillary warehouses, offices, technical rooms and Quality and Control laboratory.
• Complete construction and qualification of the HVAC system is constructed according to the EU GMP and ISO 14 644 standards, providing the fulfillment of its three basic roles: protection of the product from contamination, protection of the employees and environmental protection. Air quality is classified as Class D EU GMP (ISO 8) and ISO 9 into the secondary packaging zone.