Cefa-Cilinas Biotics Pvt. Ltd. is a leading API manufacturers, suppliers, and exporters of API in Japan. 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 state-of-the-art facilities, advanced API production processes, and robust manufacturing practices ensure full compliance with Japan’s Pharmaceutical and Medical Device Act (PMD Act) and the country’s Good Manufacturing Practice (GMP) standards, as enforced by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). This rigorous adherence guarantees that every API we produce meets the highest standards of quality, safety, and efficacy, making us a trusted partner for pharmaceutical manufacturers in Japan and international 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 Japan, our all-kinds of API producers are surrounded by the newest technology formulation like:
As the top API manufacturers and exporters of Japan, 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 Japan-based operations employ advanced automation, AI-driven monitoring systems, and state-of-the-art API manufacturing equipment, ensuring full compliance with Japan’s Pharmaceutical and Medical Device Act (PMD Act) and Good Manufacturing Practice (GMP) standards as enforced by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). Every batch undergoes rigorous quality testing under these regulations to guarantee the highest standards of purity, safety, and performance for pharmaceutical applications.
We invest heavily in research and development, staying ahead of evolving therapeutic needs and regulatory requirements, and continuously innovating our API offerings.
Cefa-Cilinas Biotics Pvt. Ltd. is a well-known API manufacturers, suppliers, and exporters of intermediates in Japan. 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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