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Natural extracts/ products
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Established in: 2006
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Employees: 20
Quality Assurance: Products are manufactured from the finest raw materials and undergo rigorous testing.
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Drug Substance (CDMO/CRO)
Drug Substance CDMOs and CROs provide end-to-end solutions for pharmaceutical companies developing and manufacturing active pharmaceutical ingredients (APIs). These organizations offer critical support in R&D, process development, scale-up, and GMP manufacturing, enabling pharma and biotech companies to accelerate time-to-market while ensuring compliance with global regulatory standards.
Natural extracts/ products
Natural extract outsourcing focuses on producing drug substance from botanical or naturally derived sources.
A pharmaceutical CDMO manages sourcing, extraction, purification, and standardization to deliver GMP-grade material.
Typical steps include raw material qualification, solvent or supercritical extraction, fractionation, and analytical standardization.
Key constraints often involve raw material variability, contaminant control, and potency consistency.
Practical answers for buyers sourcing CDMO services for natural extract drug substance manufacturing.
A natural extracts CDMO develops and manufactures drug substance derived from botanical or natural sources.
Services include extraction, fractionation, purification, and GMP release testing.
Include source material, target markers, desired potency, batch size, and target markets.
Add requirements for solvent systems, residual limits, and contaminant testing.
CDMOs implement supplier qualification, incoming testing, and standardization protocols.
Ask about traceability, seasonality plans, and acceptance criteria.
Common methods include solvent extraction, supercritical CO2, and aqueous extraction.
The method depends on the target compound and stability.
Yes, many provide chromatography or crystallization to isolate active fractions.
Confirm purity targets and yield expectations early.
Common concerns include pesticides, heavy metals, microbial contamination, and residual solvents.
Ensure the CDMO has validated analytical methods to meet regulatory limits.
Confirm GMP inspections, quality systems, and batch record control for natural product processing.
Ask about stability studies and documentation for regulatory filings.
Yes, many can scale extraction and purification from pilot to commercial.
Verify equipment compatibility with your solvent system and target yields.
Pitfalls include insufficient raw material specifications, unclear marker compound targets, and inconsistent batch potency.
Align on standardization methods early.
Most provide analytical testing such as HPLC, GC, and marker compound assays.
Confirm which methods are validated for GMP use.
Timelines depend on source material variability and extraction optimization.
New botanical sources often require additional development cycles.
Many provide documentation for drug master files or regulatory submissions.
Confirm the level of CMC support and data package formats.
Compare on sourcing controls, extraction technology, purification capability, and analytical depth.
Use this directory to shortlist based on region and services.
Some CDMOs combine extraction with semi-synthetic modifications.
Validate whether the facility has chemical synthesis capability in addition to natural product processing.
What is natural extracts and products outsourcing (CDMO)?
When to choose a CDMO for natural extracts
Common buyer requirements
Natural extracts CDMO services FAQ
What does a natural extracts CDMO do for drug substance?
What should I include in an RFQ for natural product CDMO services?
How do natural extracts CDMOs manage raw material variability?
What extraction methods are common for natural products?
Do natural product CDMOs support purification and isolation?
What impurities and contaminants are critical for natural extracts?
How do I evaluate GMP readiness for natural extracts?
Can natural product CDMOs support scale-up?
What are common pitfalls in natural extract CDMO outsourcing?
Do natural extracts CDMOs provide analytical characterization?
How long does natural product process development take?
Do natural extracts CDMOs support regulatory documentation?
How can I compare CDMO companies for natural extracts?
Can a CDMO handle both natural extracts and synthetic steps?
