Sotex PharmFirm is the basis of the production segment of the PROTEK Group. Sotex is one of Russia’s the most high-tech and innovative pharmaceutical enterprises.

    Sotex PharmFirm – high-tech EU GMP certified manufacturer. The plant located
    in Sergiev Posad district of Moscow region accomplishes full production cycle:
    preparation of injection solutions, filling of ampoules and syringes, and then
    labeling, packaging and shipment to the warehouse. All manufacturing
    processes are performed in strict compliance with the international
    requirements on the equipment of leading European concerns.

    The company benefits from an in-house R&D unit. Using advanced equipment
    and first class human resources, the unit develops a wide product range
    including biotechnical formulations.
    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.

    • Own high-tech and innovative pharmaceutical plant in Moscow region
    • Portfolio includes 156 SKUs with 122 branded products (30.06.2019)
    • Key therapeutic areas: oncology, neurology, rheumatology, nephrology, neuropsychiatry
    • Manufacturing capacity: 143 million ampoules and 13 million prefilled syringes annually
    • Unique line for manufacturing prefilled syringes with passive needle safety devices
    • Annual audits from world leading pharmaceutical manufacturers
    • R&D platform with competences of injectable and biotechnological product development
    • Exports to 16 countries

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