Nattokinase Softgel

Meta Description

Manufacturer supply compound Nattokinase softgel with Bacillus subtilis natto nattokinase(20,000 FU/g), blended CoQ10, MK‑7, D3, Vitamin E. Red oval softgel. Custom private‑label service. Complete TDS & COA available for US import compliance.

Product Overview 

Our compound Nattokinase Softgel is a multi‑ingredient cardiovascular‑support dietary softgel specially developed for North‑American supplement market. Each red oval softgel total weight is 1270mg±5%, fill content weight 930mg±5%.

Formulated with standardized Nattokinase powder (Bacillus subtilis natto, minimum 20,000 FU/g), combined with USP‑grade Coenzyme Q10(Ubiquinone), Vitamin K2 MK‑7 (≥97% all‑trans), Vitamin D3 and mixed tocopherols (Vitamin E). MCT oil acts as carrier oil together with soy lecithin & beeswax for stable oil‑phase suspension.

We are direct softgel manufacturer supporting bulk supply & private‑label OEM service. Full set of technical documentation including TDS, raw‑material COA, nattokinase fermentation flow chart, microbial test report can be provided to support US customer label design and import review.

Key Selling Points｜

✅ Standardized Nattokinase Raw Material Bacillus subtilis natto Nattokinase raw material fermented by traditional Bacillus subtilis natto strain, potency ≥20,000 FU/g. Raw material has been exported to USA since 2015, with EU novel‑food certification, multiple human clinical studies published. Full COA & fermentation manufacturing diagram available.

✅ Multi‑Synergistic Cardiovascular Complex Formula Compound formula combines Nattokinase, USP‑grade CoQ10, high‑trans‑purity Vitamin K2 MK‑7, Vitamin D3 and Vitamin E (mixed tocopherols). Multi‑nutrients work together for heart & circulatory support. All active raw materials have traceable test certificates.

✅ Stable Oil‑phase Softgel Formulation for US Export Adopt MCT oil as carrier oil, soy lecithin and beeswax as suspending agent to avoid active‑powder sediment inside softgel fill. Mixed tocopherols added as antioxidant to extend shelf‑life. Strictly controlled heavy‑metal & microbial limits to meet US import customer‑testing requirement.

✅ Flexible Shell Solution Standard shell uses pork‑source gelatin; bovine‑source gelatin shell is optional upon request. Red shell colorant formulation adjustable, iron‑oxide intake strictly controlled below human daily allowance ≤5mg per serving. Titanium dioxide content approx 0.4%.

✅ Complete Documentation for US Label & Customs Provide bulk product specification sheet(TDS), raw‑material COA, nutrition facts theoretical value, microbial test data, manufacturing flow chart. Support customer's label development and third‑party incoming laboratory testing.

✅ Factory OEM & Private‑Label One‑stop Service Oval red soft‑capsule bulk supply. Customizable shell material, packaging, label artwork. Strict in‑process control for enzyme activity, heavy metals and microbiology for US market.

Formulation & R&D Technical Introduction｜

Per‑capsule fill composition (Fill weight:933.4 mg theoretical)

Total fill weight：933.4 mg Softgel shell weight：350mg ±5%;Total capsule weight：1270mg ±5% Shell standard: Pork gelatin; Bovine gelatin optional. Contains glycerin, purified water, seductive‑red colorant, TiO₂ approx 0.4 %.

Theoretical Nutrition Facts (Per 100g, for label reference only)

⚠ Note: Above nutrition data is theoretical calculated value for label reference only, not third‑party lab measured result.

R&D Development Note

This compound softgel solved key technical challenges for oil‑powder mixed softgel:

Nattokinase powder is solid powder dispersed in oil carrier. We use MCT oil + lecithin + beeswax + mono‑diglycerides compound suspending‑system, prevent powder sedimentation during shelf‑storage and guarantee content uniformity in every softgel.

Adopt mixed tocopherols as antioxidant to protect multi‑active components against oxidation degradation.

Strictly screen nattokinase raw material: strain confirmed as Bacillus subtilis natto, potency benchmark ≥20,000 FU/g. Raw‑material has overseas market application history and clinical literature support.

Formula & shell are adjustable: gelatin source, colorant limitation, color formula can be modified to satisfy US regulatory requirement.

Production Technology & Quality Control｜

Raw‑material incoming QC inspection Each batch nattokinase powder check enzyme activity, heavy‑metal, microbial indicators; verify COA for CoQ10, MK‑7, D3 oil, MCT oil. Reject non‑compliant raw‑materials before production.

Nattokinase manufacturing flow: Soybean powder+glucose+sugar+purified water → Sterilization & fermentation with Bacillus subtilis natto → Membrane concentration → Drying → Mix with excipients → Packing.

Oil‑phase homogenization & suspension preparation Temperature‑controlled workshop, accurately weigh oil, powder, suspending agents. High‑speed homogeneous stirring system to make nattokinase powder fully and evenly suspended inside oil matrix, prevent particle settling.

Rotary‑die softgel encapsulation Adopt rotary die softgel encapsulation equipment. Precise metering pump inject fill mixture, seal and cut red oval softgel. Real‑time online monitor for fill weight variation, shell sealing integrity, capsule appearance. Pay special attention to nattokinase enzyme‑activity protection during whole temperature‑limited production process.

Controlled low‑temperature drying & conditioning Tumble pre‑drying + tray conditioning process, remove shell moisture slowly, avoid oil leakage, capsule brittleness or deformation.

Finished‑goods batch release testing Microbial specification strictly executed:

Appearance, total weight variation, disintegration time ≤30min (USP) inspection before shipment. Provide batch TDS, raw‑material COA, theoretical nutrition facts for US customer label & compliance review.

Product Specifications

FAQ

Q1: Can you provide nutrition facts including total fat and calorie per serving for label making?

A: We provide theoretical‑calculated nutrition‑fact values per 100g for your label reference only. Data includes energy, protein, fat, carbohydrate and sodium. This is theoretical value, not third‑party lab measured results. Customer can arrange independent lab testing if you need official measured nutrition‑panel data.

Q2: Is lecithin from sunflower or soybean source?

A: The lecithin used in this formula is soy‑sourced lecithin, not sunflower lecithin. The adding dosage per capsule is 2.75 mg.

Q3: Where is MCT oil sourced from, coconut or palm‑kernel?

A: MCT oil in formula is derived from palm‑kernel oil.

Q4: What is the formal name of seed oil used as Vitamin‑D3 carrier oil for label declaration?

A: The carrier oil for Vitamin D3 is Sunflower seed oil, this is official name for label.

Q5: What are exact individual mg dosage for beeswax and soy lecithin? We only have combined 34 mg number.

A: Please refer to full specification sheet:

Soy lecithin: 2.75 mg per capsule

Beeswax: 0.002 mg per capsule The rest 31.248 mg comes from mono‑ and diglycerides (28mg). Total sum of these three excipients reaches combined 34 mg. Full item‑by‑item adding quantity list is available in our specification document.

Q6: What vitamin‑E material will be applied in mass‑production?

A: We will use mixed tocopherols (mixed vitamin‑E oil) instead of single vitamin‑E oil for finished mass‑production, dosage is15 mg per capsule.

Q7: What is titanium‑dioxide percentage inside softgel shell?

A: Titanium dioxide content in red shell is approximately 0.4%.

Q8: How much iron per serving will be introduced by new red‑shell pigment? Can pigment supplier confirm Pb＜5 ppm, As＜3 ppm?

A: For mass‑production new red shell, we control iron intake per serving ≤5 mg human daily allowance.

Note: At present our domestic colorant supplier has not completed specific heavy‑metal testing for lead and arsenic for this batch of pigment, the test data Pb＜5ppm & As＜3ppm is not available yet. We suggest customer arrange independent third‑party finished‑goods heavy‑metal testing for final compliance verification for US market.

Q9: Can gelatin shell switch from pork‑source to bovine‑source gelatin?

A: Yes, bovine‑source gelatin shell is optional. Please notify us in advance when placing formal order for shell formula adjustment.

Q10: Technical details for Nattokinase raw‑material: strain, fermentation process, FU potency & US market history?

A:

Microbe strain: Bacillus subtilis natto

Nattokinase potency: minimum 20,000 FU/g

Fermentation workflow: soybean powder + glucose + sugar + purified water → sterilization & fermentation with Bacillus subtilis natto → membrane concentration → drying → add excipients → packing. We can supply manufacturing‑process flow chart document.

Market history: This nattokinase raw‑material has been exported to USA since around year 2015. Raw‑material holds EU novel‑food certification, multiple human‑clinical studies published in China & US. Raw‑material COA is available for review.

Q11: What is your MOQ & production lead‑time for this Nattokinase softgel OEM bulk order?

A: MOQ depends on shell formula & packaging solution, contact our sales team for detailed quotation and production lead‑time after raw‑material arrival. Sample capsules are available for customer pre‑validation and third‑party lab testing.

Q12: Can you support our US‑market label compliance work?

A: We provide all factory‑side technical documents (TDS, raw‑material COA, theoretical nutrition facts, microbial data, fermentation diagram). Note: Final label compliance review for US FDA / state regulation is responsibility of customer side, we suggest you consult US local regulatory consultant.

Q13: What quality control measures for US‑export order since customer will send finished goods to third‑party lab test?

A: For US‑target order, we will strengthen IQC for raw‑material potency, heavy‑metal and microbial indexes, strictly follow our finished‑goods release specification. All critical indicators will be double‑checked before shipment.

_{Erin
Shandong Zhongshun Biotechnology Co., Ltd.
Address:No.13 Longevity Food Town Park, Dande Road, Dongcheng Street, Dan County, Heze City, Shandong Province
Email: erinxu26@gmail.com
Tel/WhatsApp:+86 19560986109
WeChat: 15965312281}