At Coral Drugs, innovation begins at the molecular level. Our robust R&D and process development ecosystem forms the foundation of every Active Pharmaceutical Ingredient (API) we produce, combining scientific rigor, precision, and regulatory excellence.

Our Chemical Research & Development (CRD) team meticulously designs and optimizes synthesis routes for APIs, progressing from gram-scale to kilo-scale production. This forms the “recipe” for scalable and reproducible manufacturing. Alongside, the Analytical Research & Development (ARD) unit validates each process using advanced analytical tools such as HPLC and GC, ensuring that every batch meets its critical quality attributes. All specifications are derived from trusted pharmacopoeias like USP, EP, and IP, reinforcing our global compliance standards.

Before any process reaches commercial maturity, Coral Drugs executes extensive process optimization, both chemical and analytical. This ensures that when the process transitions from lab to pilot scale, it performs with consistent efficiency, safety, and quality.

At the pilot stage, our teams focus on validating reproducibility through controlled kilo-scale production. We conduct method validations and long-term stability studies under varied environmental conditions to predict product behavior across its lifecycle. These insights form the basis for robust scale-up to commercial production.

Our state-of-the-art manufacturing facilities are designed for excellence, equipped with cryogenic reaction systems (-20°C to -40°C), high-pressure hydrogenation setups, condensation and hydrolysis reactors, and controlled crystallisation areas for precise polymorph management. The integration of jet milling and micronization allows us to control particle size distribution, ensuring superior performance in downstream formulations. Every equipment and process aligns with GMP and 21 CFR standards, meeting the stringent expectations of global regulatory bodies.

Coral Drugs’ vertical integration strategy strengthens our reliability and independence. By developing key starting materials (KSMs) and intermediates in-house, we minimize external dependencies, ensuring continuity, quality, and cost-effectiveness across our supply chain. This approach enhances traceability, reduces lead times, and supports sustainable manufacturing practices.

Behind these processes stands our robust Quality Management System (QMS), encompassing parametric release, process controls, cleaning validation, and documentation integrity. Our QC and microbiology labs are equipped with sophisticated instruments to test APIs and ensure zero microbial burden. Sustainability is woven into our operations through an in-house Effluent Treatment Plant (ETP) that treats air and water effluents per international norms.

Every step of our journey, from R&D to regulatory filing, reflects Coral Drugs’ commitment to innovation, compliance, and patient safety. Our Regulatory Affairs team ensures seamless global submissions, preparing Drug Master Files (DMFs) for regulated markets across the US, Europe, and India.

At Coral Drugs, we don’t just manufacture APIs; we engineer trust, precision, and quality into every molecule.

Connect with Coral Drugs on LinkedIn to explore our scientific capabilities and latest innovations.

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