Cefa-Cilinas Biotics Pvt. Ltd. is a leading API manufacturers, suppliers, and exporters of API in Russia. With decades of experience in the pharmaceutical sector, Cefa-Cilinas Biotics Pvt. Ltd. has established itself as a market leader in the production of active pharmaceutical ingredients (APIs), offering a broad portfolio ranging from generic APIs to highly complex specialty molecules.
Our best facilities, advanced API production processes, and robust manufacturing practices ensure full compliance with Russia regulatory standards, including requirements set by ANVISA and other leading health authorities. This rigorous approach guarantees that every API we produce meets the highest standards of quality, safety, and efficacy, making us a trusted partner for pharmaceutical manufacturers in the Russia and global markets.
Active Pharmaceutical Ingredient (API) is the bioactive active drug ingredient of a drug product which induces the desired pharmacologic effect. API is the active drug ingredient which is used to cure the disease or condition for which the drug would be prescribed. APIs are blended with excipients or inactive ingredients to manufacture the final form such as tablets, capsules, or injectables.
With one of the top API manufacturers and suppliers in Russia, our all-kinds of API producers are surrounded by the newest technology formulation like:
As the top API manufacturers and exporters of Russia, our various API manufacturers are newly highlighted and used extensively in various applications such as:
Partnering with one of the world’s leading API producers, Cefa-Cilinas Biotics Pvt. Ltd. combines quality, innovation, and reliability at every stage of production. Our Russia-based operations feature advanced automation, AI-driven monitoring systems, and best API manufacturing equipment, ensuring that all products meet the stringent regulatory standards set forth by Russian authorities.
We adhere to the EAEU Good Manufacturing Practice (GMP) requirements, as stipulated by the Eurasian Economic Union’s Resolution No. 77 of November 3, 2016, which mandates compliance for API manufacturers within the union. This certification is overseen by the Ministry of Industry and Trade of the Russian Federation and executed by the State Institute of Drugs and Good Practices (FSI SID&GP). Additionally, we comply with the Federal Law No. 61-FZ on the Circulation of Medicines, which governs the registration and quality control of pharmaceutical substances in Russia.
Cefa-Cilinas Biotics Pvt. Ltd. is a well-known API manufacturers, suppliers, and exporters of intermediates in Russia. As manufacturers of oncology APIs and paracetamol APIs, our extensive product line is versatile enough for various therapy areas and international markets. Our strict adherence to regulatory standards, modern world-class manufacturing plants, and ongoing research and development ensure that we are the first choice of pharmaceutical multinational companies for API and drug manufacturing services excellence. With ongoing upgrades and expansion, we pledge to create global well-being through innovative Active Pharmaceutical Ingredients. Contact us today for more information!
We are certified by ANVISA, WHO-GMP, and ISO 9001 to achieve global quality and safety standards. We also have DMF documentation in hand for regulated markets across the world.
Yes, we do offer customised synthesis and scale-up services according to individual client specifications. Our R&D members communicate with the client in thorough coordination to present solutions for individual client specifications.
We employ the latest analytical methods like HPLC, GC-MS, and LC-MS for quality and purity tests. Each batch is rigorously quality-tested and strictly complies with the pharmacopeial standards like USP, EP, and BP.
Yes, all our APIs are completely in accordance with ANVISA requirements as well as international GMP requirements. We also provide regulatory filing support where customers can achieve successful market access.
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