Citicoline (CDP Choline) Supplement Manufacturer & Private Label Partner
At KS Nutripharma®, we are a vertically integrated dietary supplement manufacturer specializing in citicoline (CDP choline) OEM and private label solutions.
With more than 19 years of manufacturing experience, 5 production bases, and over 81,000 m² of GMP-compliant facilities, we support projects ranging from small pilot runs to billion-unit global supply programs.
Our capabilities cover the entire product lifecycle—from raw material sourcing and formulation development to stability testing, manufacturing, packaging, and international regulatory support.
Backed by 7 automated supplement production lines, 2 independent R&D centers, and a portfolio of more than 500 commercialized formulations, we help brands accelerate product development while maintaining consistent quality and supply security.
Whether you are launching a private label brain health supplement or developing a customized nootropic formula, KS Nutripharma delivers scalable manufacturing, full traceability, and the regulatory expertise required for long-term growth.
Custom Formulation Solutions for Your References
Our R&D team develops production-ready citicoline stacks optimized for real retail channels. Every formula below has been validated for stability, flavor, and shelf-life. No theoretical concepts—only manufacturable products.
Available Supplement Formats
Full dosage-form manufacturing capability for Citicoline-based products:
Expandable Ingredient Library
Click on any category to request a full specification sheet, MOQ, and pricing.
Trending Ingredients Frequently Combined with Citicoline
| Ingredients | Branded Source | Why Brands Request It | Best Paired With |
|---|---|---|---|
| Magtein® | AIDP | Magnesium form with brain-targeting research | Citicoline for premium focus |
| KSM-66® | Ixoreal | Full-spectrum ashwagandha with the most clinical studies | Citicoline for stress-resilient focus |
| Sharp-PS® | Enzymotec | Soy-free phosphatidylserine from sunflower | Citicoline for healthy aging |
| BioPQQ® | Mitsubishi | PQQ with mitochondrial biogenesis research | Citicoline for cellular energy |
| Lion’s Mane | Host Defense / Generic | NGF-supporting mushroom with growing consumer awareness | Citicoline for premium nootropics |
| Suntheanine® | Taiyo | Patented L-theanine with established purity profile | Citicoline for calm focus |
| DHA | life’sDHA® (DSM) / Generic | Algae or fish-derived omega-3 for brain structure | Citicoline for healthy aging |
Citicoline (INN name), also known as CDP-Choline or Cytidine Diphosphate Choline (CAS 987-78-0), is a naturally occurring mononucleotide found in every human cell. It serves as an essential intermediate in the biosynthesis of phosphatidylcholine, the primary phospholipid of neuronal membranes. Upon oral administration, citicoline is rapidly metabolized to choline and cytidine, both of which readily cross the blood-brain barrier and are resynthesized into CDP-choline in the central nervous system.
Mechanism of Action:
- Neuronal Membrane Repair: Provides cytidine for phospholipid resynthesis, maintaining membrane integrity and fluidity.
- Acetylcholine Synthesis: Choline is the direct precursor to acetylcholine, the neurotransmitter governing memory formation, learning and attention.
- Neuroprotection: Supports mitochondrial cardiolipin preservation and reduces oxidative stress-induced phospholipid degradation.
Authoritative Sources:
- PubMed — Citicoline metabolism and mechanisms: https://pubmed.ncbi.nlm.nih.gov/9305321/
- PMC — Citicoline: A Superior Form of Choline? https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6683073/
- EFSA Scientific Opinion on citicoline safety (Novel Food): https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6683073/ (citing EFSA Journal 2013;11:3421)
Memory Support
A randomized, double-blind, placebo-controlled trial published in Nutrients (PMC) evaluated 100 healthy older adults (ages 50–85) with age-associated memory impairment (AAMI). After 12 weeks of supplementation with 500 mg/day citicoline (Cognizin®), participants showed statistically significant improvements in episodic memory (Paired Associate test: P = 0.0025) and composite memory scores (P = 0.0052) compared with placebo. This study is registered at ClinicalTrials.gov (NCT03369925).
- Source: https://pmc.ncbi.nlm.nih.gov/articles/PMC8349115/
Focus & Attention
Multiple RCTs demonstrate that citicoline enhances attentional performance in healthy populations. A dose-response trial in acute ischemic stroke patients (n=259) found that 500 mg citicoline produced optimal functional outcomes as measured by the Barthel Index and NIH Stroke Scale, with no drug-related serious adverse events.
- Source: https://pubmed.ncbi.nlm.nih.gov/9305321/
Healthy Brain Aging & Neuroprotection
A 12-month observational study of 347 post-stroke patients found that citicoline-treated subjects showed significantly better outcomes in attention-executive functions (OR 2.379, 95% CI 1.269–4.462, P = 0.007 at 12 months) and temporal orientation compared with controls. The study concluded that citicoline is safe and probably effective in improving post-stroke cognitive decline.
- Source: https://pubmed.ncbi.nlm.nih.gov/23406981/
Comparative Efficacy: Citicoline vs. Choline Alphoscerate (Alpha GPC)
A 2025 systematic review and meta-analysis (Frontiers in Neurology, PROSPERO CRD42024626782) compared citicoline and choline alphoscerate (Alpha GPC) in dementia patients. While choline alphoscerate showed superior SCAG scores in some domains, both agents demonstrated comparable safety profiles (dropout rates: 6.7% vs. 9.4%, OR 1.44, 95% CI 0.66–3.13), supporting citicoline as a well-tolerated alternative with dual membrane-repair and cholinergic mechanisms.
- Source: https://pubmed.ncbi.nlm.nih.gov/41426989/
Additional Clinical References:
- Cochrane Database Systematic Review — CDP-choline for cognitive disturbances in elderly: https://pubmed.ncbi.nlm.nih.gov/15846601/
- Kyowa Hakko Cognizin® acute brain-wave study (ISSN 2026): https://www.nutritioninsight.com/news/kyowa-hakko-cognizin-citicoline-brain-wave-study.html
In health-related categories, product quality directly impacts consumer safety. Our QC system exceeds industry baseline standards.
Identity Testing
- Every batch of citicoline raw material is verified by Infrared Spectroscopy (IR) and Nuclear Magnetic Resonance (NMR) before release to production.
- Objective: Eliminate adulteration, substitution, and misidentification risks.
HPLC Assay (Potency Verification)
- Method: High-Performance Liquid Chromatography (HPLC) with UV or ELSD detection
- Specification: Citicoline content ≥98.0% (USP / EP monograph reference)
- Tolerance: Finished product label claim deviation controlled within ±5% (tighter than USP <2023> requirements)
- Reference: USP Monograph for Citicoline Sodium — https://www.uspnf.com/
Heavy Metal Testing
- Method: Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
- Limits: Lead (Pb) ≤0.5 ppm; Arsenic (As) ≤0.5 ppm; Cadmium (Cd) ≤0.3 ppm; Mercury (Hg) ≤0.1 ppm
- Compliance: USP <232>/<233>, California Proposition 65, EU Regulation (EC) No 1881/2006
Microbiological Testing
- Total Aerobic Count, Yeast & Mold, E. coli, Salmonella, Staphylococcus aureus
- Compliance: USP <61>/<62>, ISO 11133
Stability Studies
- Accelerated Stability: 40°C / 75% RH for 6 months (ICH Q1A)
- Long-Term Stability: 25°C / 60% RH for 24 months
- Purpose: Supports shelf-life claims and expiration dating on product labels
Third-Party Testing & COA
- All finished products are available for independent re-testing by accredited third-party laboratories (e.g., Eurofins, SGS, ALS).
- Certificate of Analysis (COA) provided with every batch, including: identity, assay, heavy metals, microbiology, moisture, and physical characteristics.
- Downloadable COA sample available in our Document Center.
This is the first module procurement teams review. Complete transparency on material identity, purity, and physical properties.
| Parameter | Specifications |
| Product Name | Citicoline (CDP Choline) / Citicoline Sodium |
| CAS Number | 987-78-0 (Citicoline); 33818-15-4 (Citicoline Sodium) |
| Active Ingredient | Citicoline Sodium (≥98.0% by HPLC) |
| Appearance | White to off-white crystalline powder |
| Solubility | Freely soluble in water; sparingly soluble in ethanol |
| Molecular Weight | 510.31 g/mol (Citicoline Sodium) |
| pH (1% aqueous solution) | 2.5 – 3.5 (indicative of inner salt form) |
| Related Substances (5′-CMP) | ≤1.0% (hydrolysis indicator; critical stability control point) |
| Particle Size | ≥95% through 80 mesh (ensures uniform blend flowability) |
| Heavy Metals | Pb ≤0.5 ppm; As ≤0.5 ppm; Cd ≤0.3 ppm; Hg ≤0.1 ppm |
| Microbiology | TAMC ≤1,000 CFU/g; TYMC ≤100 CFU/g; Pathogens absent |
| Shelf Life | 24 months under cool, dry conditions (≤25°C, RH ≤60%) |
| Storage | Store in tightly sealed container; protect from moisture and light |
| Bulk Packaging | 1 kg aluminum foil bag / 25 kg fiber drum with inner liner |
| Finished Goods Packaging | HDPE bottle (60/120/180 count), blister pack (10/30 count), stick pack (14/30 count), sachet (single-serve) |
Actual dosage recommendations must comply with local regulatory frameworks (FDA, EFSA, TGA, NHPD). The following ranges reflect commonly studied and commercially deployed potencies.
Memory Support — 250 mg/day
- Clinical Basis: McGlade et al. (2012) demonstrated attentional improvements at 250 mg/day in healthy adult women.
- Market Positioning: Entry-level daily maintenance; suitable for general wellness and senior health lines.
- Source: https://pmc.ncbi.nlm.nih.gov/articles/PMC8349115/
Focus & Cognitive Performance — 500 mg/day
- Clinical Basis: The Nutrients AAMI trial (NCT03369925) used 500 mg/day for 12 weeks, showing significant episodic memory improvement (P = 0.0025).
- Market Positioning: Mid-tier nootropic; ideal for professional focus and student performance products.
- Source: https://pmc.ncbi.nlm.nih.gov/articles/PMC8349115/
High-Performance Nootropics — 1,000 mg/day
- Clinical Basis: Stroke-recovery literature (Clark et al., 1997) identified 500 mg as optimal for functional recovery, while higher doses up to 2,000 mg have been safely administered in acute settings.
- Market Positioning: Premium gaming/esports and executive-performance formulations.
- Source: https://pubmed.ncbi.nlm.nih.gov/9305321/
Clinical-Strength Formulas — 1,000–2,000 mg/day
- Clinical Basis: Post-stroke vascular cognitive impairment trials (Alvarez-Sabin et al., 2013) utilized extended high-dose protocols with favorable safety profiles.
- Market Positioning: Medical-food adjacent or practitioner-channel products (where local regulations permit).
- Source: https://pubmed.ncbi.nlm.nih.gov/23406981/
Regulatory Disclaimer: Dosage claims on finished product labels must be reviewed for compliance with target-market regulations. We provide regulatory guidance as part of our turnkey service.
Citicoline is not a one-segment ingredient. Its clinical versatility allows deployment across multiple consumer and professional channels.
Brain Health Supplements: General cognitive maintenance for adults 35+; positioned as daily neuro-nutrition.
Memory Support Products: Age-associated memory impairment (AAMI) targeting; supported by NCT03369925 trial data.
Healthy Aging Formulas: Longevity and anti-aging portfolios; pairs with CoQ10, omega-3, and PS.
ADHD / Focus Support Products: Non-stimulant attention support for children and adults; often stacked with magnesium and zinc.
Esports & Gaming Supplements: Reaction-time and working-memory support for competitive gamers; typically combined with caffeine and L-theanine.
Student Focus Supplements: Academic performance and exam-prep positioning; back-to-school seasonal campaigns.
Executive Cognitive Performance: White-collar productivity and “mental stamina” products; B2B corporate wellness channels.
Functional Beverages & RTDs: Water-soluble citicoline enables incorporation into ready-to-drink shots, sparkling waters, and powdered drink mixes.
| Ingredients | Primary Mechanism | Choline Content | Key Differentiator |
| Citicoline (CDP-Choline) | Neuroprotection + Acetylcholine synthesis + Phospholipid membrane repair | 18.5% choline by weight | Dual cytidine + choline delivery; crosses BBB efficiently; supports both structural and functional brain health. Most clinically validated nootropic choline form. |
| Alpha GPC (Choline Alfoscerate) | Direct acetylcholine precursor via glycerophosphocholine | 40% choline by weight | Highest choline density per gram; rapid elevation of plasma choline; strong for acute cognitive enhancement. |
| Choline Bitartrate | Basic choline salt for acetylcholine synthesis | 41% choline by weight | Lowest cost per gram; poor BBB penetration; primarily supports liver methylation rather than cognitive function. |
| Phosphatidylcholine (PC) | Membrane phospholipid + choline source | 13% choline by weight | Supports liver health and cell membrane structure; lower bioavailability for brain choline elevation; derived from soy or sunflower lecithin. |
Procurement Recommendation:
- For premium nootropic positioning: Citicoline or Alpha GPC (or both in synergy).
- For cost-sensitive mass market: Choline Bitartrate (with clear label transparency on lower brain bioavailability).
- For liver/detox positioning: Phosphatidylcholine (separate from cognitive claims).
United States
- Status: Citicoline is a self-affirmed GRAS (Generally Recognized As Safe) ingredient for dietary supplements. No NDI (New Dietary Ingredient) notification is required due to its history of safe use prior to DSHEA (1994).
- FDA Facility Registration: Our facility is registered with FDA and undergoes routine inspections.
- Labeling: Structure/function claims permitted under 21 CFR 101.93; no disease claims without FDA-approved health claim or NDA.
- Reference: Kyowa Hakko Cognizin GRAS Self-Affirmation (2009) — http://www.kyowa-usa.com/news/2009/05-28.html
European Union
- Status: Citicoline is authorized as a Novel Food ingredient under Commission Implementing Decision 2014/423/EU (July 1, 2014).
- EFSA Safety Opinion: Positive scientific opinion issued in 2013 (EFSA Journal 2013;11:3421). No safety concerns regarding genotoxicity identified.
- Health Claims: EFSA has not authorized a cause-and-effect relationship for “memory function” claims (EFSA 2024 opinion). Permissible claims relate to neuronal membrane integrity and normal choline metabolism under Regulation (EC) No 1924/2006.
- Reference: EU Novel Food Authorization — https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32014D0423
- Reference: EFSA Safety Opinion (cited in PMC review) — https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6683073/
Canada
- Status: Citicoline is listed in the Natural Health Products Ingredients Database (NHPID) and is eligible for NPN (Natural Product Number) applications.
- Support: We provide full NPN application documentation, including evidence summaries and quality summaries.
Australia
- Status: Citicoline is permitted as a complementary medicine ingredient under TGA guidelines.
- Support: TGA listing documentation and GMP clearance certificates available upon request.
Middle East & Southeast Asia
- Halal Certification: Full Halal documentation available (certified by recognized Islamic authority).
- Kosher Certification: Orthodox Union (OU) or equivalent certification available.
- Saudi Arabia SFDA / UAE MOHAP: Product registration dossier support provided.
Bulk Packaging (Raw Material)
- 1 kg aluminum foil bag with nitrogen flush (for R&D and pilot batches)
- 25 kg fiber drum with double polyethylene liner (for commercial production)
- Custom bulk sizes available for large pharmaceutical or food-manufacturing clients
Retail Packaging (Finished Goods)
- HDPE Bottles: 60cc, 120cc, 180cc with child-resistant caps (CRC) or standard screw caps
- Amber Glass Bottles: 60cc, 120cc with desiccant inserts for premium positioning
- Blister Packs: PVC/PVDC or aluminum-aluminum cold-form foil; 10-count travel packs, 30-count monthly packs
- Stick Packs: Single-serve 1–5 g sachets; matte or glossy film; vertical or horizontal fill-seal
- Sachets / Pouch Packs: Multi-layer laminated film with tear notch and reseal zipper options
- Retail Cartons: Custom-printed folding cartons with UV coating, embossing, or foil stamping
- Display Boxes: PDQ trays and shelf-ready packaging for retail and club-store channels
Global Logistics & Incoterms
- FOB (Free On Board): Port of departure — client arranges ocean/air freight and insurance
- CIF (Cost, Insurance, Freight): We arrange freight to destination port; client handles customs clearance
- DDP (Delivered Duty Paid): Door-to-door service including customs clearance and duties; available for US, EU, UK, Australia, Canada, and select Asian markets
- Air Freight: 5–10 days transit; ideal for urgent samples, pilot batches, and high-value orders
- Sea Freight: 20–45 days transit; FCL (20′ / 40′) and LCL options for cost-efficient bulk shipments
- Amazon FBA Direct: We can ship directly to Amazon fulfillment centers (FBA) in US, UK, EU, and Japan with compliant labeling and palletization
- Raw Material Qualification
Incoming citicoline raw material undergoes identity verification (IR/NMR), HPLC assay, heavy-metal screening (ICP-MS), and microbiological testing. Only materials meeting USP/EP and internal specifications are released to inventory. COA from the raw-material supplier is cross-checked against our independent testing. - Formula Development & Stability Pre-Assessment
R&D scientists evaluate excipient compatibility, moisture sensitivity, pH interaction, and flow properties. A preliminary stability protocol (accelerated, 40°C/75% RH) is designed before any pilot batch is produced. - Lab-Scale Prototyping
1–5 kg batches are manufactured under production-equivalent parameters. Samples are evaluated for appearance, disintegration/dissolution, assay uniformity, and organoleptic properties. - Pilot Production
50–200 kg batches validate scale-up parameters: mixing uniformity, compression force curves, capsule fill weights, or gummy depositing viscosity. Process validation data is documented for regulatory submissions. - Accelerated & Long-Term Stability Testing
ICH Q1A-compliant stability chambers monitor physical, chemical, and microbiological parameters over 3, 6, 12, 18, and 24 months. Data supports shelf-life claims and regulatory dossiers. - Commercial Production
Full-scale manufacturing under cGMP conditions with batch records, equipment logs, environmental monitoring, and in-process controls (IPCs) at defined intervals. - Finished Product Testing
Every production lot is tested for: identity (IR), potency (HPLC), uniformity of dosage units (USP <905>), dissolution/disintegration (USP <701>/<2040>), heavy metals (ICP-MS), and microbiology (USP <61>/<62>). - Packaging & Labeling
Automated bottling, blister sealing, cartoning, and case packing. Label compliance is verified against approved artwork. Serialization and aggregation available for markets requiring track-and-trace. - Global Shipment & Documentation
Commercial invoice, packing list, certificate of origin, COA, stability summary, and regulatory certificates are compiled per shipment. Temperature-controlled shipping (2–8°C or 15–25°C) available upon request.
Case Study 1: US Nootropic Brand — 0 to $2M ARR in 14 Months
- Challenge: A direct-to-consumer (DTC) nootropic startup needed to launch a 4-SKU citicoline-based line within 60 days to capture back-to-school season demand.
- Solution: We provided turnkey OEM service: formula finalization (Citicoline 250mg + Caffeine 100mg + L-Theanine 200mg), label compliance review, HDPE bottle packaging, and Amazon FBA direct shipment.
- Results: Product launched in 58 days. First 90 days: 12,000 units sold. Year 1: $2.1M annual revenue. Repeat order cycle reduced to 12 days with reserved production capacity.
- Key Factor: Fast lead time + regulatory-ready documentation enabled immediate Amazon listing without compliance delays.
Case Study 2: European Healthy-Aging Brand — Cost Reduction & Quality Upgrade
- Challenge: A German private-label brand was sourcing citicoline capsules from a mid-tier European contract manufacturer with inconsistent lead times (45–60 days) and variable assay results (±12% deviation).
- Solution: Tech transfer to our facility with optimized direct-compression tablet process (Citicoline 500mg + PS 100mg). Implemented ICP-MS heavy-metal screening and HPLC assay with ±3% tolerance.
- Results: Manufacturing cost reduced by 18% through excipient optimization and scale economies. Lead time stabilized at 18 days. Customer complaint rate dropped from 2.3% to 0.1%. Product now listed in 3 EU pharmacy chains.
- Key Factor: Vertical integration (raw material → finished goods) eliminated intermediary margins and quality-handoff risks.
Case Study 3: Australian Esports Brand — Gummy Format Innovation
- Challenge: An Australian gaming supplement brand needed a differentiated delivery format for a crowded nootropic market. Target demographic: 18–30 male gamers who reject traditional capsules.
- Solution: Developed low-moisture-activity citicoline gummies (250mg/serving) with natural berry flavor, using pectin-based vegan matrix. Stability validated under ICH Q1A for 18 months.
- Results: Product became the brand’s #1 SKU within 6 months. TGA listing achieved in 8 weeks. Now exported to New Zealand and Singapore.
- Key Factor: Dosage-form innovation (gummies) + regulatory agility (TGA documentation support) created first-mover advantage in the ANZ esports nutrition segment.
Clinically Researched Ingredient: Unlike many “trending” nootropics with limited human data, citicoline has decades of peer-reviewed research across stroke recovery, vascular cognitive impairment, and healthy aging. PubMed indexes 1,000+ citations. This scientific depth reduces regulatory risk and supports premium pricing.
Growing Consumer Demand: Search volume for “cdp choline benefits” and “citicoline supplement” continues to rise year-over-year. The nootropic category is expanding from biohacker niches into mainstream wellness, creating first-mover opportunities for brands that launch now.
Multiple Delivery Format Flexibility: Citicoline’s water solubility and thermal stability enable deployment across capsules, tablets, gummies, powders, stick packs, and RTD beverages. One ingredient can populate an entire product line.
Premium Positioning Opportunity: Citicoline carries a higher perceived value than basic choline bitartrate. Brands can command 30–50% higher price points when positioning around “clinically studied brain health” rather than generic choline.
Synergistic Formulation Potential: Citicoline pairs elegantly with Alpha GPC, Lion’s Mane, Bacopa, PS, caffeine, and L-theanine. This stackability allows you to build differentiated product portfolios without sourcing dozens of exotic ingredients.
Strong Differentiation from Generic Choline: Choline bitartrate dominates the low-cost mass market but offers minimal brain bioavailability. Citicoline’s dual cytidine + choline mechanism provides a clear, defensible technical story for premium brands.
Flexible MOQ & Scalable Production
- Standard Formulas: MOQ 1,000 bottles / pouches per SKU
- Custom Formulas: MOQ 3,000 units (adjustable based on dosage form complexity)
- Pilot-to-Commercial Scale: Seamless tech transfer from lab batch to 500M+ unit annual capacity
Fast Lead Times
- Standard Formulas: 15–20 business days after order confirmation and artwork approval
- Custom Formulas: 30–45 business days (includes stability pre-testing and first-article inspection)
- Repeat Orders: 10–15 business days with reserved production slots
- Rush Orders: Expedited scheduling available for seasonal launches and inventory replenishment
Full-Package Packaging & Design Support
- Packaging Formats: HDPE bottles, amber glass bottles, aluminum blister packs, stick packs, sachets, retail cartons, display boxes
- Label Compliance Review: FDA 21 CFR 101.93 (US), EU Regulation (EC) No 1924/2006 (health claims), NHPD (Canada), TGA (Australia)
- Multi-Language Label Support: English, Spanish, German, French, Arabic, Japanese, Chinese
- Amazon FBA-Ready Labeling: UPC/EAN barcodes, FNSKU labels, suffocation warnings, country-of-origin marking
Formula Development & IP Protection
- R&D Team: 15 scientists, including 3 PhD-level formulation specialists with 15+ years of functional ingredient experience
- Annual Output: 200+ new formulations developed per year
- Patent Licensing: Access to proprietary synergistic compositions (available under licensing agreement)
- NDA & Confidentiality: Standard mutual NDA executed before any formula disclosure; IP ownership remains with the client
One-Stop OEM / ODM Turnkey Service
- Scope: Raw material sourcing → Formula development → Pilot production → Stability testing → Commercial manufacturing → Packaging → Global logistics → Regulatory documentation
- Benefit: Single point of accountability reduces communication overhead and quality-risk fragmentation.
Cost Advantage & Transparent Pricing
- Direct raw-material partnerships with Kyowa Hakko Bio Co., Ltd. (Cognizin® authorized supplier) and other USP-grade citicoline producers eliminate intermediary markups.
- Volume-tier pricing with locked annual contracts for forecasted volumes.
- No hidden tooling fees for standard bottle and cap sizes.
Proven Track Record
- 50+ brain-health brands served across North America, Europe, Australia and Southeast Asia
- 3 Amazon Top-100 Nootropic brands under long-term manufacturing contracts
- Zero FDA warning letters; zero product recalls; 99.2% on-time delivery rate (2023–2024)
Why Partner With KS Nutripharma®
Manufacturing Scale & Infrastructure
| Metric | Specifications |
|---|---|
| Years in Operation | 19+ years |
| Total Facility Area | 81,000+ m² (≈872,000 sq ft) GMP-compliant production campus |
| Manufacturing Bases | 5 dedicated production facilities |
| Employees | 260+ |
| Supplement Production Lines | 7 high-speed, automated lines |
| Raw Material Processing Lines | 5 dedicated lines for extract concentration, drying, and milling |
| Cultivation Bases | 4 raw material cultivation bases for traceable botanical sourcing |
Daily Production Capacity
| Dosage Form | Daily Output | Annual Capacity (Est.) |
|---|---|---|
| Softgels | 2+ million / day | 600+ million / year |
| Hard Capsules | 5+ million / day | 1.5+ billion / year |
| Tablets | 12+ million / day | 3.6+ billion / year |
| Gummies | 2+ million / day | 600+ million / year |
| Powder & Granules | – | 5,000+ tons raw material capacity/year |
Research & Development
| R&D Infrastructure | Details |
|---|---|
| R&D Centers | 2 independent research and development centers |
| Formulation Library | 500+ developed and commercialized formulations |
| Services | Custom formula development, stability testing, bioavailability optimization, taste masking, and regulatory documentation |
Quality Assurance & Certifications
- GMP Certified — Current Good Manufacturing Practice for dietary supplements
- FDA Registered — US FDA facility registration; 21 CFR Part 111 compliant
- ISO 9001 — Quality management systems
- HACCP — Hazard Analysis Critical Control Points
- HALAL Certified — Suitable for Muslim markets
- KOSHER Certified — Suitable for Jewish dietary laws
- BRCGS — Global food safety standard
- EU export documentation (COA, MSDS, stability data, written confirmations)
- Health Canada and TGA (Australia) regulatory packages available
- Third-party lab verification for heavy metals, microbes, and potency on request
Global Reach & Brand Partnerships
| Metric | Details |
|---|---|
| Exported Countries | 60+ |
| Global Brands Served | 500+ |
| Supply Chain | Direct sourcing from 4 cultivation bases and 5 raw material processing lines |
Vertical Integration: From Seed to Shelf
4 Cultivation Bases
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5 Raw Material Processing Lines (powder, extraction, concentration, drying)
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7 Supplement Production Lines (softgels, capsules, tablets, gummies, powders)
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QC & Stability Testing
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Packaging & Global Logistics- Consistent potency — Direct control over raw material standardization
- Competitive pricing — No middleman markup on key actives like plant-based extract
- Full traceability — Lot-to-lot tracking from cultivation to finished product
- Faster lead times — In-house raw material inventory reduces procurement delays
For OEM and private label projects, we typically provide a comprehensive documentation package to support product development, regulatory review, import clearance, and commercial launch.
Standard Documentation Package
Raw Material Documents
Certificate of Analysis (COA)
Specification Sheet
Ingredient Origin Statement
Allergen Statement
Non-GMO Statement (if applicable)
Halal / Kosher Certificates (if requested)
Quality & Safety Documents
Heavy Metal Test Report
Microbiological Test Report
Residual Solvent Report (if applicable)
Third-Party Laboratory Reports (upon request)
Batch Traceability Records
Finished Product Documents
Finished Product COA
Master Formula Sheet
Nutrition Facts / Supplement Facts Draft
Label Compliance Review
Shelf-Life & Stability Summary
Packaging Specification
Regulatory & Export Documents
FDA Registration Information
cGMP Compliance Statement
ISO 22000 / HACCP Certificates
Free Sale Certificate (if available)
Certificate of Origin
Commercial Invoice & Packing List
