Manufacturing
Today, Medsintez is a high-tech pharmaceutical company where drugs go through all stages of their life cycle: from the development to sales.
On the plant's premises, a research lab complex has been created to carry out scientific and practical work on the development and study of new domestic medicines, as well as an experimental area for testing and scaling the developed technologies. |
Technological equipment from the world's leading manufacturers, which allows to produce high-quality products and successfully pass certification, was mounted at the plant. |
Our experts have extensive experience in promoting innovative medicines. Currently, Medsintez products are sold in all territorial entities of the Russian Federation and abroad. Fruitful cooperation with state bodies on programs for supplying the population with affordable drugs is going on. |
The production building area is 2,140 m2. A complex of clean rooms with an area of 400 m2, including rooms of B, C, D clean grades. Production capacity - 24 million containers per year.
The production building area is 4000 m2. A complex of clean rooms (the area is 952 m2), including E, F, D, C clean grade rooms. Production capacity - 1 billion tablets annually.
The production building area of recombinant human follicle-stimulating hormone API is 564 m2. A complex of clean rooms with an area of 290 m2, including C and D clean-grade rooms. Production capacity - up to 30 grams of API per year.
The production building area is 4000 m2. A complex of clean rooms with an area of 386 m2, including A, B, C, D clean-grade rooms.
The production capacity allows satisfying 100% of Russia's demand for recombinant and analogue human insulin preparations and 200% for recombinant human follicle-stimulating hormone preparation.
Area of the production site - 800 m². There are 3 lines in the production of active pharmaceutical substances:
Quality
Quality, safety and efficacy of medicines are «Medsitntez» plant's top priorities.
The Quality Director's service structure, which includes the quality control and assurance departments, is in full compliance with GMP standards.
The core staff was trained at Bayer AG in Leverkusen and Berlin. All plant employees were trained in GMP requirements at special training organizations or at the enterprise itself.
The plant has the МС ISO 9001:2015 quality control system in place.
Quality control of finished products is carried out in the plant's laboratories accredited by Roszdravnadzor and FMBA of the Russian Federation.
The Medsintez plant’s awards:
A prize of the Russian Government
for achieving significant results in terms of quality and services, as well as for the implementation of highly effective management techniques (2007)
A prize of the Commonwealth of Independent States
for achievements in the field of product and service quality (2009)
The plant successfully passes numerous Russian and foreign inspections annually.
Torgovaya 15, Novouralsk, Sverdlovsk region, Russia, 624130