Pharmaceutical & Nutraceuticals – High‑Purity Ingredients for APIs, Excipients & Functional Supplements

In pharmaceutical and nutraceutical manufacturing, purity, consistency, and regulatory readiness are non‑negotiable. Saigao’s pharmaceutical & nutraceutical ingredients – from fermentation‑derived intermediates to high‑grade prebiotic fibers and plant extracts – meet the most stringent quality standards. cGMP‑compliant production, full impurity disclosure, DMF support, and batch‑level traceability. Whether you are formulating an API, an excipient, or a clinical nutrition product, our vertically integrated supply chain delivers the reliability you require.

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Pharmaceutical & Nutraceuticals

Pharmaceutical Intermediates – Fermentation‑Derived, cGMP‑Compliant

We produce high‑purity intermediates for API synthesis and excipient applications using controlled fermentation and enzymatic processes.

Product range: Custom and standard intermediates including organic acids, amino acid derivatives, and specialty fermentation metabolites. All are manufactured in dedicated cGMP lines.
Quality by design: Each batch is tested for:
- Residual solvents (ICH Q3C)
- Heavy metals (Pb, As, Cd, Hg – ICP‑MS)
- Related substances (HPLC area %)
- Microbial limits (USP <61>/<62>)
- Endotoxins (LAL test for injectable grades)
Regulatory support: We provide complete documentation packages:
- DMF (Drug Master File) preparation and maintenance
- Stability data (ICH Q1A)
- Process validation reports
- Supplier qualification packages
- Regulatory response support for FDA, EMA, CFDA/NMPA
Traceability: Full audit trail from fermentation media (all plant‑based, no animal‑derived peptides) to final packaging. All processing aids disclosed.

Application areas: Oral solid dosage forms, parenteral intermediates, topical formulations, and clinical trial materials.

Prebiotics, Plant Extracts & Functional Fibers

Nutraceutical Actives – Prebiotics, Plant Extracts & Functional Fibers

For dietary supplements and functional foods, we offer high‑bioavailability ingredients with standardized actives and clean‑label profiles.

Prebiotic fibers & oligosaccharides (Pharma grade): FOS, GOS, XOS, IMO, inulin, resistant dextrin, polydextrose. Ultra‑low endotoxin and heavy metal levels suitable for sensitive populations (pediatric, geriatric, immunocompromised). Typical purity >98% by HPLC.
Standardized plant extracts (Nutraceutical grade):
- Green tea extract (EGCG 50–98%, caffeine‑free option)
- Grape seed extract (proanthocyanidins >95%)
- Ginseng extract (ginsenosides 10–80%)
- Milk thistle extract (silymarin 80%)
- Ginkgo biloba (flavonoids 24%, terpenes 6%)
- Lotus leaf, hawthorn, and more
- HPLC assay, residual solvent analysis, pesticide residue screening, and heavy metal testing included.
Maltitol (Pharma/Nutra grade): Sugar‑free excipient for chewable tablets, lozenges, and medicated confectionery. Low glycemic index (GI=35), non‑cariogenic. Particle sizes optimized for direct compression.
Bulk actives: For high‑volume nutraceutical manufacturers, we supply custom blends and private‑label packaging. R&D support for dissolution enhancement and taste masking.

Dual‑market advantage: Many of our nutraceutical ingredients are produced on the same cGMP lines as pharmaceutical intermediates – giving you pharmacy‑grade quality for your supplement products at competitive prices.

We provide Certificates of Analysis (CoA) to USP, EP, or JP standards upon request.

FAQs

FAQ – Pharmaceutical & Nutraceuticals with Saigao

What regulatory standards and certifications do your pharmaceutical ingredients meet?

Our pharmaceutical intermediates are manufactured under cGMP (21 CFR Part 210/211). We hold ISO 9001:2015 and FSSC 22000, with Kosher (OU) and Halal (IFANCA) available for many products. We can test to USP, EP, JP, and ChP standards. For specific APIs or intermediates, we support DMF filings and provide ICH stability data. All products are subject to full residual solvent, heavy metal, and microbial testing.

Do you provide DMF support and regulatory submission assistance?

Yes. We maintain DMFs for key pharmaceutical intermediates and can prepare or amend a DMF for your specific product. Our regulatory team provides:

Type II DMF (for API/intermediate)
Letter of Authorization (LOA)
Stability data packages (real‑time and accelerated)
Process validation and change control documentation
Response support for FDA/EMA deficiency letters

We work directly with your regulatory affairs department to shorten submission timelines.

What is the difference between your nutraceutical and pharmaceutical grades?

Parameter	Nutraceutical Grade	Pharmaceutical Grade
Purity	≥98% (HPLC)	≥99.5% (HPLC)
Endotoxins	Not specified	<1.0 EU/mg (LAL)
Heavy metals	≤10 ppm total	ICH Q3D limits
Residual solvents	Class 3 only	ICH Q3C (all classes)
Documentation	CoA, SDS, spec sheet	Full DMF, stability, validation
Pricing	Competitive	Premium for high‑purity

We help you select the right grade based on your target market, dosage form, and regulatory pathway.

Can you support clinical trial material manufacturing or small‑batch production?

Absolutely. We offer:

Clinical trial batches (as low as 5–10 kg) under cGMP
Scale‑up services from pilot (50–200 kg) to commercial (5+ MT)
Custom purification (recrystallization, column chromatography, distillation)
Restricted substance controls (genotoxic impurities, elemental impurities)
Confidentiality agreements for proprietary processes