Answering common questions
About the company
Yes, we are a full‑cycle Russian pharmaceutical company. Our production facility is located in the city of Khimki, Moscow Oblast.
We work with both Russian and international partners.
Our company was founded in 2005. You can learn more about the history of MiraxBioPharma here.
Наше производство находится в Московской области, в Химках — по адресу: ул. Рабочая, д. 2А, стр. 1. Здесь размещены модернизированные производственные участки, научный центр и собственный лабораторный комплекс.
Services
We offer a full range of services for the contract development and production of pharmaceuticals and dietary supplements.
We can support the project on a full‑cycle basis: from the idea and formulation development to registration, production, and packaging. Or we can get involved only at a certain stage. We can carry out a full‑scale transfer of an existing production facility to our capacity. We know that every project is unique — and we will help you realize your idea.
Learn more about our services here.
Contract manufacturing involves producing items under your brand at our manufacturing facility. We can manage the entire project on a turnkey basis, or step in at any specific stage—whether that means developing a formula, selecting a product format, preparing documentation, or handling the technology transfer to move the production process to our facilities.
We can create an analogue of a product available on the market for you (a complete analogue in terms of components, or an alternative composition with the same effect). We can develop a complementary dietary supplement to complement your cosmetic line or in line with the logic of your service.
We manufacture the following products under contract:
- pharmaceuticals (coated and uncoated tablets, dry-filled and liquid‑filled capsules);
- dietary supplements (tablets, capsules with dry and liquid fillings, sachets, liquid forms)
Yes. We are ready to discuss in detail the target properties, technologies, product packaging, and intended positioning. We can develop a fundamentally new product or create an analogue of an existing product on the market (a complete analogue in terms of components, or an alternative composition with the same effect).
We work not only with pharmaceutical companies and brands of dietary supplements and medicinal products, but also with players in related categories. We would be happy to create a complementary dietary supplement to complement your cosmetic line or to align with the logic of the service you provide.
Dietary supplements (DS). To start producing and selling dietary supplements, the product must undergo state registration. This includes producing a trial batch, conducting its examination, and obtaining regulatory approval in any EAEU country. The cost of state registration of dietary supplements depends on the complexity of the components. The registration process takes about 3 months. We are ready to take on the development, production of a trial batch, registration, and serial production of dietary supplements at any stage of their development.
Pharmaceuticals. To begin mass production and sale of pharmaceuticals, it is necessary to go through a long process from pharmaceutical development to state registration, including preclinical and clinical studies, and optionally, a bioequivalence study. This requires several years of work and substantial investments. We are ready to join the project at any stage: formulation development, research, or mass production.
Yes, we provide full documentation support for production, including the development of regulatory documentation and product registration.
Production and quality control
We use modern equipment for:
- dry-fill encapsulation;
- liquid-fill encapsulation into hard capsules;
- tableting;
- tablet coating;
- sachet packaging;
- liquid filling;
- secondary packaging into blisters, jars, cartons, and vials.
Our production facility holds a license to manufacture pharmaceuticals, as well as certificates confirming compliance with Good Manufacturing Practice (GMP) rules, the requirements of GOST R 56202-2014, GOST R ISO 9001-2015 (ISO 9001:2015), and GOST R ISO 22000-2019 (ISO 22000:2018 HACCP). When conducting clinical and preclinical studies, we adhere to the requirements of good practices GCP and GLP.
You can view MiraxBioPharma’s current licenses and certificates here.
We ensure quality control at every stage of production through:
- strict adherence to Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), and International Organization for Standardization (ISO) guidelines;
- advanced equipment that enables a wide range of testing for raw materials and finished products at all stages of production.
In addition, the high quality of our products is supported by collaboration with trusted suppliers and the use of high-grade raw materials and components throughout the entire manufacturing process.
We are ready to sign a non-disclosure agreement (NDA) with each client. If the contract includes any development work, all results will remain the property of the client.
Collaboration
To start cooperation, please fill out the contact form on our website ([link to the form]) or reach out to us by phone at +7 (495) 721-20-58, +7 (916) 280-96-61 or via email: cp@mbpharma.ru.
To conclude a contract with our company, you will need to provide registration documents, documents confirming the authority of the signatory, and banking/payment details.
We work with clients from Russia and CIS countries, and also support product entry into international markets.
Each batch of products is accompanied by a certificate of analysis confirming its quality and compliance with regulatory documentation.
Business terms
The minimum order quantity is 5,000 units of the product.
If we are talking about a product from our catalog of ready‑made solutions, we will be happy to provide you with product samples.
For new formulations, the conditions for manufacturing the first batch are discussed individually and largely depend on whether the development of production technology, the ordering of rare active ingredients, or special auxiliary components is required. In any case, we are always interested in the success of partner projects and find convenient solutions.
Yes, we provide product samples for evaluation.
The timeframe for launching a new product is individual and largely depends on the complexity of the project, the specifics of the raw materials, and the order volume.
При начале сотрудничества, мы согласуем с вами сроки планируемых отгрузок и заранее поставим ваш продукт в производственный план. Если сформировать годовой календарь отгрузок затруднительно, мы рекомендуем формировать новые заявки за 2-3 месяца до желаемой даты отгрузки, чтобы встроить изготовление вашего продукта в очередь производственного процесса и процедур необходимого контроля.
As soon as the necessary final inspection is completed and the quality documentation is prepared, we will be ready to ship the ordered products to you. Delivery terms are discussed on an individual basis and specified in the contract.
Every project is unique, so we can only provide estimated timelines.
Launching a new dietary supplement brand on the market is quite quick. If the product is selected from our list of ready‑made and registered formulations, the customer only needs to approve the design and place an order for packaging materials. Such orders are completed within 2–3 months.
If a new composition is planned, its scientific and technological development will be required, as well as the state registration procedure. Such projects are usually implemented within a period of up to 6 months.
Launching a new pharmaceutical will take much longer than launching a dietary supplement. It can take 5–10 years from the emergence of the idea for a new drug to its launch on the market: full pharmaceutical development of the formula, preclinical studies to test the hypothesis and confirm the mechanism of action; then phase I and phase II clinical trials involving volunteers for a comprehensive assessment of safety and efficacy. Only after that is it possible to register the medicinal product, which is accompanied by mandatory confirmation of the quality control of the production process.
Запуск воспроизведенного препарата (дженерика) проще и быстрее, и может занять около полутора лет. Так как этап фармразработки и подробных исследований уже пройден при создании оригинального лекарственного препарата, для воспроизведенного препарата не требуется продолжительных клинических и доклинических исследований. Обычно достаточно исследовния биоэквивалентности; иными словами, необходимо доказать совпадение формулы с воспроизводимым (оригинальным) препаратом.
Условия оплаты всегда обговариваются индивидуально и зависят от многих факторов, среди которых объем серии, доступность необходимого сырья, сложность и продолжительность предварительных работ и многое другое. В любом случае, мы стараемся быть гибкими и всегда учитываем интересы заказчика.