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.
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.
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.
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.
| 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.
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
Our R&D team of 30+ scientists can collaborate on process optimization and impurity profiling. Lead times for clinical batches: 4–6 weeks.
