In 2016 the ampoule production of Sotex received the European GMP
certificate. This certificate was issued by the Portuguese National Institute of Pharmacy and Medicines. Successful passing of the certification procedure for compliance with European GMP standards is the result of many years of work on the organization of production and the introduction of a modern quality management system. The presence of the European GMP certificate puts Sotex on a par with the world’s leading manufacturers and allows the company to adequately represent Russia on the international market.

Drug production uses water for injections obtained from our own artesian well through a multistage process of purification and distillation. Before the prepared solution ends up in an ampoule or syringe, it is analyzed using chemical and microbiological indicators and undergoes a sterilizing filtration process. The ampoules themselves are handled just as carefully. They are washed in an ultraviolet tank, rinsed with water for injections using a syringe, blown with compressed air, and sterilized at 320°C. The clean sterile ampoules enter the filling and sealing zone. Filling takes place in a localized area, where the product is protected from contaminants using a laminar stream of sterile air. The filled and sealed ampoules enter an inspection zone to check for physical inclusions and an airtight seal. Then the ampoules are automatically labeled, stamped, and packaged.

Quality control is performed in every stage of production. Each ampoule is automatically checked for seal quality, fill volume, airtightness under the
influence of an electric charge. The plant employs a system to automatically
identify ampoules using colored rings. Each product has its own ring color.
Ampoules with a different color ring are rejected automatically. In quality
control labs, we perform acceptance tests on samples and interoperational
testing of the drugs: from preparation of the solution to filling and packaging.
The quality control team currently numbers about 100 people. Maintaining the necessary personnel qualifications with consideration of the enterprise’s requirements, the possibility of growth, continuous training, and mastery of advanced technologies are fundamental and mandatory conditions for the team’s success and Sotex’s key to high quality products.

Partnerships with foreign pharmaceutical manufacturers are one of the most important components of the PROTEK Group production segment business activity. Sotex takes pride in its unique experience of cooperation with world’s pharmaceutical industry leaders in the field of licensed manufacture and promotion of ready formulations. The company offers a full range of services, from registration, production, and distribution of medicines to retail sales. It also offers extensive marketing support and assistance.

We provide our foreign partners with practical solutions, which speed up and facilitate localization of the manufacturing process in Russia in full compliance with EU GMP standards.

Advantages of such a partnership have already been appreciated by many
leading pharmaceutical companies: Sanofi, Bayer, Takeda, Novartis, Sandoz,
Pierre Fabre.

Partnership opportunities:
– Licensed production
– Commercialization of innovative and high-tech products
– Marketing support

The company’s product portfolio includes more than 150 popular items, which have won the trust of specialists and consumers, as well as drugs used in socially significant areas of medical treatment: neurology, oncology, rheumatology, nephrology, psychoneurology, etc.

Sotex’s state-of-the-art and effective medications comply with western clones in terms of quality and are more economical.

A key feature of Sotex’s assortment policy is the orientation toward the production of the widest possible range of dosage forms, dosages and formulations of drugs that enable physicians to optimize and modify drug therapy depending on the needs of an individual patient.

A wide range of dosages and ease of use not only facilitate the work of doctors and nurses, but also enable individual selection of treatment regimens. Thus, making the work of professionals more convenient, the company takes care of the health of patients.