API's
Active Pharmaceutical Ingredients
Active Pharmaceutical Ingredients
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Salius Pharma is a Government of India Recognized Star Export House and ISO 9001: 2015 Certified pharmaceutical company, engaged in developing and exporting of high quality Active Pharmaceutical Ingredients (APIs) and pharma intermediates worldwide. With its emphasis on chronic therapy segments such as CNS, Anti-Diabetic, Cardiovascular, Respiratory diseases, Arthritis, and Oncology, We offers DMF-on request for APIs along with full regulatory documentation.
Our strategic alliances developed globally help us to achieve faster growth rate and gain support from our distributors, customers and major pharmaceutical formulation manufacturing companies. Our Company always focus on the offer the superior quality products at very competitive price to our esteem customers which is most important factor to retain the trust for long time and maintain the strong Business association with various international customers. One of the strongest USP of Salius Pharma is to ensure quality, compliance, and consistency at every stage.
Know MoreExplore our key Active Pharmaceutical Ingredients
Manufacturing at Salius Pharma is not just mere production; it is a science-driven discipline.
Our associate facilities across India integrate advanced synthesis technologies, regulatory compliance systems, and automation-enabled process control to deliver APIs to international pharmacopeial standards such as USP, EP, BP, JP, and IP. We specialize in chronic therapy APIs, maintaining consistency, purity, and reproducibility from the lab to plant scale.
Each of the units are WHO-GMP, ISO 9001:2015, and ISO 14001:2015 certified to align globally with regulatory requirements of USFDA, MHRA, TGA, INVIMA, ANVISA, and GCC.
The synthesis platforms combine multi-step organic reactions, high-vacuum distillation, and controlled crystallization technologies to deliver APIs with defined polymorphic purity and tight particle-size distribution, D90 < 10 µm.
Our Process Development Centre bridges research innovation with scalable manufacturing.
Quality is not a simple certification at Salius Pharma — It's a way of life.
Our manufacturing associates work under WHO-GMP and ISO 9001:2015 norms, guaranteeing uniform purity, stability, and safety in every batch.
Our QA and Regulatory Affairs teams provide traceability for regulatory purposes and transparency in documentation, supporting customers in achieving global registration norms seamlessly.
Our Regulatory Affairs team is specialized in the preparation and submission of technical documents like Drug Master Files (DMF) and Certificates of Suitability to the European Pharmacopoeia (CEP) , especially for USA, European union, Australia, Asia, Latin America and other regions with Marketing Authorization applications. We assist all our partners and associates throughout the entire documentation and registration process, meeting USFDA, ANVISA, INVIMA, MHRA, GCC, TGA and SFDA standards.
Our mission is to deliver quality medicines and build a progressive, caring, and patient-focused work culture.
We are committed to providing the highest quality APIs, produced in state-of-the-art facilities and tested to rigorous standards.
Our manufacturing processes are in full compliance with global Good Manufacturing Practices, FDA and WHO-GMP.
Our scientific expertise includes synthetic chemistry, analytical chemistry, and process engineering, ensuring top-notch API development.
We continuously invest in research and development to innovate and improve our existing APIs while developing new, cutting-edge molecules.
Our track record of consistency, reliability and on-time delivery has earned us the trust of pharmaceutical companies worldwide.
We are committed to sustainable manufacturing practices and reducing our environmental impact.
Salius Pharma proudly serves clients in over 25 countries, offering end-to-end support from dossier preparation to product registration and logistics coordination.
Our logistics and production model are designed for global reliability.
Consistent batch reproducibility for large-scale customers.
The Security Documentation for DMF-ready APIs.
Timely regulatory filings, customer-specific customization Seamless Export Compliance for Latin America, Middle East and Central Asia.
Stay informed with our recent announcements, exhibitions, and product launches
We are excited to announce our participation at CPhI Worldwide 2025 to showcase our latest API innovations.
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We proudly introduce Rivaroxaban API to our growing cardiovascular portfolio, meeting global regulatory standards.
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Salius Pharma signs a strategic collaboration with a leading EU-based pharma company to strengthen supply chains.
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