Dr. Dhanapal R

Experienced API Process Research & Development leader with over 22 years in synthetic organic chemistry and process development. Developed scalable and cost-effective synthetic routes for APIs, guiding projects from laboratory to commercial manufacturing. Led multidisciplinary teams, managed global regulatory submissions, and resolved manufacturing challenges, contributing to successful product launches. Inventor on multiple patents and author of several peer-reviewed publications.

• 22+ years of experience in API Process Research & Development, Synthetic Organic Chemistry, Process Optimization, Technology Transfer, and Commercialization for regulated and emerging markets.
• Successfully completed technology transfer of more than 15 API products from Process R&D to commercial manufacturing, ensuring robust, scalable, and commercially viable processes.
• Inventor/co-inventor on 8 Indian and US patent applications/grants covering innovative and non-infringing API manufacturing processes.
• Successfully addressed 25+ US DMF deficiency responses, facilitating timely regulatory approvals and product commercialization.
• Prepared and submitted responses for 36 CEP (Certificate of Suitability) regulatory queries, ensuring compliance with European regulatory requirements.
• Responded to 40+ customer and regulatory queries from less-regulated markets, supporting product registrations and lifecycle management.
• Led the preparation of approximately 156 Nitrosamine Risk Assessment reports for commercial and pipeline APIs, ensuring compliance with global regulatory expectations.
• Developed numerous novel, cost-effective, scalable, and non-infringing synthetic routes for APIs serving regulated and domestic markets.
• Delivered effective plant troubleshooting and technical support, resolving manufacturing process issues, improving process robustness, and minimizing production downtime.
• Successfully resolved customer technical queries by providing scientific justifications, root-cause investigations, and process improvement recommendations.
• Applied Quality by Design (QbD) and Design of Experiments (DoE) methodologies to optimize manufacturing processes, improve yields, and enhance process robustness.
• Strong expertise in impurity profiling, impurity synthesis, process optimization, scale-up, technology transfer, and commercialization of complex API molecules.
• Proven leadership in managing multidisciplinary R&D teams and collaborating with Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, and Supply Chain to deliver projects on time.