Your Trusted CDMO Partner For Advanced Intermediates & APIs

At Siddhartha Chemical, we provide comprehensive Contract Development and Manufacturing (CDMO) services for small molecules, supporting pharmaceutical innovators and biotech companies worldwide. Our expertise spans New Chemical Entity (NCE) development, advanced intermediates, and API manufacturing, covering preclinical to clinical phases (Phase I/II/III), product launch, and full-scale commercialization.

Why Partner with Siddhartha Chemical?

We act as an extension of our clients' R&D and manufacturing teams, offering dedicated scientific expertise, agile project execution, and seamless scale-up capabilities. Our goal is to accelerate drug development while maintaining the highest standards of quality, regulatory compliance, and innovation.

Process development & optimization

Analytical Method Development & Validation

Impurity Profiling & Genotoxic Evaluations

Kilo, Pilot & ton-level Scale Manufacturing under cGMP

CMC & Regulatory Support

Polymorph Studies

Stability studies

Comprehensive Development Workflow

Our systematic multi-phase execution methodology for drug development.

Phase 01

Process Development & Optimization

Phase 02

Analytical Method Development & Validation

Phase 03

Impurity Profiling & Genotoxic Evaluations

Phase 04

Kilo, Pilot & Ton-Level Scale Manufacturing under cGMP

Phase 05

CMC & Regulatory Support

Phase 06

Polymorph & Salt Screening Studies

Phase 07

ICH Stability Studies

Our Key Service Offerings

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Process Development & Optimization: Route scouting, process design, and cost-efficient scaling.
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cGMP Manufacturing: High-quality production under stringent regulatory standards.
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Analytical Method Development & Validation: Ensuring accurate characterization and quality control.
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Impurity Profiling & Genotoxic Evaluations: Comprehensive assessments for regulatory compliance.
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Salt Screening & Polymorph Studies: Identifying optimal forms for enhanced stability.
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Custom Synthesis: Tailored synthesis solutions, from kilogram to multi-kilogram scale.
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Kilo and Pilot Scale Manufacturing: GMP and non-GMP production for toxicology batches, ensuring seamless scale-up processes.
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Drug Substance Manufacturing: APIs, NCEs, Key Starting Materials (KSMs), and Regulatory Starting Materials (RSMs) for clinical and commercial supply.
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ICH Stability Studies: Conducting stability studies per International Council for Harmonisation (ICH) guidelines.
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CMC & Regulatory Support: Complete Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions.

Key Capabilities

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Experienced Team: Over 10 years of industry expertise per scientist.
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Proven Track Record: Development of over 100 products, with 50+ successfully scaled to commercial production.
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Advanced Infrastructure: Specialized reactors (stainless steel, glass-lined, Hastelloy), and capabilities for hydrogenation, halogenation, Heck and Suzuki couplings, high-vacuum distillations, etc.
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Backward Integration: Ensuring supply chain reliability and cost efficiency.
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Integrated Project Management: Streamlined coordination and execution of projects.

Research & Development Strengths

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State-of-the-Art Labs: Equipped with 10+ fume hoods, a kilo lab (200L, 50L, and 20L).
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Specialized Reactions: Expertise in hydrogenation, halogenation, Heck and Suzuki couplings, among others.
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Spike & Purge Studies: Enhanced control over intermediate and API quality.
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Parallel Development Capabilities: Managing 10-15 products simultaneously.
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Advanced Analytical Tools: Full scale ADL Lab.
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Comprehensive Literature Access: SciFinder, Reaxys for in-depth research.

Manufacturing Plant Infrastructure

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Regulatory Approvals: USFDA, EU GMP, WHO GMP, ISO 9001:2015, ISO 14001:2015, ISO 45001:2018.
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Capacity & Expansion: Over 100 KL reactor volume, with an additional 100+ KL under expansion.

Global Accreditations

At Royal Pharma, we are committed to delivering high-quality, efficient, and compliant CDMO services to accelerate your drug development journey.

USFDA

WHO GMP

ISO Certified

Local WHO GMP

Contract Development & Manufacturing