About the plant

         Zavod Medsintez specializes in the manufacture of pharmaceutical products. Currently, the plant produces infusion solutions and finished dosage forms of recombinant human insulin. Zavod Medsintez is one of the first in Russia to have established industrial production of finished dosage forms of recombinant human insulin that meet GMP EC requirements.

Production

The plant has implemented the Quality Management System according to MS ISO 9001:2008. The structure of Quality unit, including quality control and quality assurance departments, is fully compliant with GMP standards. All the key personnel have had practical training at Bayer AG in Leverkusen and Berlin. All the employees have had training in GMP requirements at external agencies and directly at the plant.

Instrumentation of the plant workshops with new high-tech equipment enables to get successfully audited for recertification of conformity with European GMP standards and to release high quality products. The quality control of finished products is conducted at the plant laboratories that have been authorized by the Federal Service on Surveillance in Healthcare (Roszdravnadzor) and Federal Medical and Biological Agency of the Russian Federation. Zavod Medsintez received the Russian Federation Government Prize for achievement of significant results in the area of quality and services as well as introduction of highly efficient management methods (2007) and the CIS Quality Award (2009).

Products

The main product of Zavod Medsintez is Rosinsulin in cartridges, vials and pre-filled injection pens manufactured at the workshop for recombinant human insulin production. Additionally, the plant has a workshop producing I.V. solutions in the amount sufficient to satisfy 20% of Russias demand. The manufacturing line includes Sodium Chloride Solution (0.9%), Glucose Solution (5, 10, 20%), Ringer Solution, etc.

Prospects

In addition to the manufacture of licensed products Zavod Medsintez is also engaged in developing new pharmaceuticals. Currently, new types of I.V. solutions and innovative biopharmaceutical products are being developed.