CDMO Services & Custom Synthesis

CDMO

Contract Development & Manufacturing

Comprehensive contract manufacturing services that span the entire lifecycle, from development to full-scale production. We partner with pharmaceutical companies globally to deliver reliable, GMP-compliant manufacturing solutions.

End-to-end lifecycle management
GMP-compliant production
Process optimization & validation
Regulatory documentation support

CRO / CMO

Custom Synthesis of Organic Molecules

Tailored synthesis of organic molecules with expertise in CRO and CMO, offering solutions for unique research and manufacturing needs. We handle complex multi-step synthesis with precision and speed.

Milligram to multi-kilogram scale
Complex multi-step synthesis
Chiral and achiral compounds
Rapid turnaround delivery

Intermediates

Advanced Intermediates & KSMs

High-quality manufacturing of advanced intermediates and key starting materials (KSMs) for pharmaceutical and chemical industries. Our rigorous quality controls ensure consistency across every batch.

Pharmaceutical-grade purity
Consistent batch-to-batch quality
Full CoA & analytical data
Scalable supply chain

API Impurities

API Impurity Synthesis

Expert synthesis of active pharmaceutical ingredient (API) impurities to ensure quality and regulatory compliance. We help manufacturers meet ICH Q3A/B guidelines with certified reference standards.

ICH Q3A/Q3B compliance
Degradation product synthesis
Related substances & metabolites
Certified reference materials

Specialty

Specialty Chemicals

Providing specialized chemicals for a range of industries, tailored to specific technical and operational needs. From coupling reagents to contrast agent intermediates, we manufacture with precision.

Buffer & coupling reagents
Contrast agent intermediates
Protected amino acids
Urea & glycine derivatives

Scale-up

Scale-up & Technology Transfer

Seamless scale-up from laboratory to commercial production with effective technology transfer processes. Our team ensures process robustness and reproducibility at every production scale.

Lab to pilot to commercial
Process robustness studies
Knowledge transfer & training
Full tech transfer packages

How We Work

CDMO Engagement Process

A streamlined, transparent tech transfer and manufacturing pipeline designed to accelerate your clinical timelines while maintaining strict GMP compliance.

RFP & Technical Evaluation

Submit your request for proposal (RFP), including target molecule structures, synthetic routes, and desired scales. Our technical team initiates a deep engineering evaluation under a secure non-disclosure agreement (NDA) to map out the chemistry.

Feasibility, Route Optimization & Partner Matching

Our internal process R&D team assesses the chemistry for safety, cost-efficiency, and scalability, then matches your project with the optimal, pre-qualified GMP facility from our trusted manufacturing network before presenting a comprehensive proposal with milestones, regulatory parameters, and transparent pricing.

Tech Transfer, Auditing & Manufacturing Oversight

Upon project kick-off, our specialists handle the complete technology transfer and analytical method development, managing outsourced production end-to-end with rigorous QC/QA oversight, on-site audits, and regular project management updates.

Regulatory Release, Delivery & Lifecycle Support

We ensure secure shipment of your advanced intermediates or products under strict temperature-controlled logistics, with every batch delivered with full regulatory documentation, including a CoA and regulatory data packages (DMF/CMC) for your global filings.

Why Hestur Pharma

Trusted by Pharma Companies Globally

We combine deep chemistry expertise with responsive customer service to deliver on-time, on-spec results every single time. Our team of experienced chemists works closely with each client to understand unique needs and provide tailored solutions.

Quality Assurance

Every product undergoes rigorous quality testing with full analytical documentation ensuring strict industry compliance.

Fast Turnaround

Streamlined workflows ensure quick response times and firm on-time delivery commitments.

Dedicated Partnership

A dedicated project manager ensures seamless communication and transparency throughout your project lifecycle.

60+

Clients Served

100+

Molecules Developed

21K+

KG Delivered

10+

Achievements

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