Chemical Development & Manufacturing

Phase-appropriate Development and Manufacturing Services

As an experienced CDMO partner, Shilpa provides phase-appropriate development and manufacturing across the entire drug lifecycle. Our cross-functional teams of chemists, engineers and analysts design safe, efficient and scalable processes to support pre-clinical, clinical and commercial programs.

Integrated Solutions Across the Supply Chain

We deliver integrated solutions that span lab development, pilot and commercial manufacturing. With decades of experience across diverse chemistries, our teams design and execute experiments with a rigorous focus on process safety, scalability and quality, supporting NCEs and APIs across all clinical phases and for commercial supply.

Shilpa's CDMO Services Excellence

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Industry-Leading Innovation

Among the early Indian companies to establish a dedicated HPAPI suite (OEL 1–5), enabling safe development and manufacture of cytotoxic and highly potent APIs.

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Comprehensive Chemistry Portfolio

Extensive experience in small molecules, peptides, polymers and specialty chemicals using state-of-the-art development and manufacturing facilities.

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Specialized Manufacturing

Segregated oncology and non-oncology suites with appropriate containment, isolators and controlled material/personnel flows.

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Full Lifecycle Support

Support from route scouting and process development through validation, regulatory documentation and long-term commercial supply.

Advanced Chemical Capabilities

State-of-the-Art Chemical Development

Complex Chemistry Expertise

•High pressure reactions with Pd/Ru/Rh catalysts
•Asymmetric synthesis and chiral chemistry
•Cryogenic reactions (down to –90°C)
•Electrochemical and enzymatic transformations

Specialized Chemistry

•Boron, nucleoside and steroid chemistry
•Grignard and organolithium reactions
•Heterocyclic chemistry (e.g., indole, pyridine, pyrimidine)
•Cytotoxic oncology products using isolator technology

Development Scale Capabilities

Development Phase	Scale Range	Key Capabilities
Pre-clinical	mg to g scale	Route scouting, POC development, feasibility studies
Early Phase Development	g to kg scale	Process optimization, safety assessment, analytical method development
Late Stage Development	kg to MT scale	Commercial route development, process validation, regulatory support
Commercial Manufacturing	MT+ scale	cGMP manufacturing, supply chain management, quality assurance

HPAPI Excellence & Safety Leadership

Shilpa operates dedicated HPAPI facilities with OEL 1–5 capabilities, supported by advanced containment and isolator technology. Segregated oncology and non-oncology suites, dedicated intermediary areas and validated cleaning strategies ensure safety for operators, products and the environment.