Drug Substance

NCE Development Solutions

At Shilpa Pharma, we are committed to supporting pharma and biotech companies in developing New Chemical Entities by providing end-to-end solutions across the entire drug development lifecycle while maintaining the highest standards of safety, quality, and efficiency.

Our expertise in route scouting, proof-of-concept studies, process research, risk assessment, and scale-up ensures that we deliver high-quality, scalable, and regulatory-compliant drug substances.

Route Scouting

We specialize in identifying and developing the most efficient synthetic routes at the early stage of a program. Our experienced scientists and process engineers focus on evaluating different pathways to optimize yield, purity, and cost-effectiveness.

Through detailed feasibility studies and a phase-appropriate approach, we ensure that the chosen route aligns with the requirements of early-stage research, clinical trials, and commercial manufacturing.

Route Scouting

Manufacturing Solutions

At Shilpa Pharma, we offer end-to-end contract development and manufacturing solutions, ensuring seamless progression from concept to commercial.

With over 35 years of expertise, state-of-the-art infrastructure, and a commitment to regulatory excellence, we provide high-quality, scalable, and compliant drug substance manufacturing services tailored to the evolving needs of the pharmaceutical industry.

Pre-Clinical Supply

At Shilpa Pharma, we support pharma, mid-pharma, biotech, and academia in accelerating early development through pre-clinical development and manufacturing. Our expertise in route scouting, feasibility studies, and small-scale nGMP & GMP production enables partners to access early-stage material for toxicological and proof-of-concept studies.

Our scientific team optimizes synthetic routes and develops robust processes to ensure a smooth transition from concept to commercialization. Our analytical capabilities ensure method development, validation, and reliability of early-stage data.

Pre-Clinical Supply

Countries We Serve in

Fill the Form