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CONTRACT MANUFACTURING · LINDEN NJ · RENO NV

Capabilities & Spec Sheets.

What follows is not marketing copy. These are procurement-grade spec sheets for our three manufacturing categories — encapsulation, gummy nutraceuticals, and cosmeceutical skincare. Each panel lists formats, tolerances, testing methods, regulatory pathways, MOQ, and lead times against an industry median, so you can audit fit before requesting a consult.

DOC REV DMG-CAP-2026.03
EFFECTIVE 11 MAR 2026
CLASSIFICATION BUYER — INTERNAL
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§ 01 — INDEX

Three capabilities. One spec manual.

Each chapter below is a self-contained spec sheet with formats, tolerances, regulatory pathways, MOQ, and lead times. Read in any order — jump straight to the category that matches your SKU brief.

  1. 01

    Encapsulated Supplements

    Powder, beadlet, and oil-suspension fills into HPMC, gelatin, and acid-resistant shells — sizes 000 through 4 — with inline NIR potency verification on every batch.

    Open spec sheet → ENCAP-SPEC
  2. 02

    Gummy Nutraceuticals

    Vegan pectin, gelatin, and carrageenan matrices in 2–6 g dose formats with flavor-load limits, actives-stability windows, and soft-chew lead times.

    Open spec sheet → GUMMY-SPEC
  3. 03

    Cosmeceutical Skincare

    Topical serums, creams, and balms with actives encapsulation, challenge and stability testing, and ISO 22716 cosmetic GMP compliance end-to-end.

    Open spec sheet → COSM-SPEC
§ 02 — CHAPTER 01

Encapsulated Supplements

14d prototype-to-capsule 5,000 MOQ units 0.18% NIR potency CV
01

Capsule Formats & Shells

  • Shell typesHPMC, bovine gelatin, fish gelatin, acid-resistant DRcaps™
  • Sizes stocked000 · 00 · 0 · 1 · 2 · 3 · 4
  • Two-piecePowder fill, beadlet blend, oil suspension, tablet-in-capsule
  • Custom colorUp to 8 pigment slots, FDA 21 CFR 73 & 74 compliant
  • Vegetable certificationVegan Society, USDA NOP, Kosher Pareve on request
02

Fill Weight & Tolerance

  • Fill-weight tolerance± 1.5% of target (sizes 00–2) · ± 2.0% (000, 3, 4)
  • Working range80 mg – 1,400 mg
  • Active assay window95.0 – 110.0% of label claim (USP <905>)
  • Uniformity of doseAV ≤ 15 across n=30, n=10/3 procedure
  • Disintegration≤ 15 min in 0.1 N HCl (USP <2040> default)
03

Inline NIR Potency Verification

  • MethodSciAps PharmaID NIR, in-line on encapsulation bench
  • Spectra per capsule3 averaged scans, every 250th unit sampled
  • Reported CV0.18% across 2024 production runs (n=47 SKUs)
  • UpchargeNone — included as standard on every batch
  • Data exportPer-unit CSV + PDF certificate of analysis on every run
04

MOQ, Lead Time & Regulatory

  • MOQ — new SKU5,000 units (~60% lower than category standard of 12,500)
  • MOQ — repeat run2,500 units (existing formula, validated tooling)
  • Prototype turnaround14 calendar days from approved formula
  • Regulatory pathwaysNDIN, structure/function (21 CFR 101.93), NSF Sport, Prop 65
  • Compliance backboneISO 22716 · cGMP 21 CFR 111 · NSF GMP for Sport · QAI Organic
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§ 03 — CHAPTER 02

Gummy Nutraceuticals

21d prototype-to-deposit 25,000 MOQ units 6 actives stability-window variants
01

Matrices & Base Formats

  • Pectin (vegan)Apple / citrus pectin, clean-label claim compliant
  • GelatinBovine, porcine, or fish (per allergen map)
  • Carrageenaniota-carrageenan for soft-chew tooth and body
  • Shapes stockedBear, square, dome, mini-rectangle, custom mold (8 wk)
  • Dose per piece2.0 g · 3.0 g · 4.0 g · 6.0 g workable
02

Flavor & Color Load

  • Flavor load0.6 – 1.8% w/w (extract) · 0.05 – 0.20% (WONF)
  • Color loadCarmines, annatto, spirulina, turmeric, caramel — 0.02 – 0.5%
  • Sugar profileSucrose, allulose, monk fruit, erythritol blends
  • CoatingsSanded, oiled, acid-shield, or naked
  • Allergen mapBuilt per SKU; cross-line allergen cleaning validated
03

Actives Stability Windows

  • Heat-sensitive (probiotics, enzymes)pH 3.2–3.7, post-coat, ≤ 35°C deposit
  • Vitamins (B, C, multi)Citrus buffer + iron-as-fumarate variant
  • Botanical extractsDual-coat beadlet, validated 18-month potency
  • Water-soluble mineralsChelate form, validated 12-month potency
  • Shelf life (default)18 months from date of manufacture, ICH Q1A accelerated
04

Testing, MOQ & Lead Times

  • In-house testingMoisture, water activity, pH, Brix, hardness, COA per batch
  • Third-partyEurofins, Covance, Mérieux — TDP panel on request
  • MOQ — new SKU25,000 units (single matrix / single flavor)
  • MOQ — repeat run10,000 units (existing mold, validated formula)
  • Prototype-to-deposit21 calendar days (vs. 56-day category median)
SHELF-LIFE NOTE

Default accelerated stability per ICH Q1A covers 18 months at 25°C/60% RH. Sub-12-month windows are flagged on the feasibility memo if your actives outpace matrix protection — never silently.

§ 04 — CHAPTER 03

Cosmeceutical Skincare

28d prototype-to-fill 2,500 MOQ units ISO 22716 cosmetic GMP
01

Topical Formats

  • SerumsOil, water, and bi-phase droppers · 15–50 mL
  • Creams & lotionsO/W, W/O, lamellar; airless pump and jar
  • BalmsAnhydrous, hot-fill, tin or stick
  • Masks & gelsHydrogel, sheet-impregnation, overnight leave-on
  • Airless packs15 mL · 30 mL · 50 mL · 100 mL available
02

Actives Encapsulation

  • Encapsulation typesLiposomal, solid-lipid nanoparticle, cyclodextrin, polymeric
  • RetinoidsEncapsulated retinol 0.025 – 1.0%, oxygen-excluded fill
  • Vitamin CTHD ascorbate, MAP, ethyl ascorbic acid variants
  • PeptidesValidated for residual solvent and pro-purity
  • SPF boostersInactive-to-active ratio graded per mineral filter load
03

Stability & Challenge Testing

  • Stability programLong-term 25°C/55% RH, accelerated 40°C/75% RH
  • Challenge testUSP <51> antimicrobial at n=3 timepoints per SKU
  • CompatibilityPackaging interaction per FDA cosmetic guidance, ICH Q8/Q9
  • Default shelf24 months from manufacture, period-after-opening (PAO) tagged
  • PhotostabilityOptional, ICH Q1B on retinoid and vitamin C SKUs
04

MOQ, Lead Time & Compliance

  • MOQ — new SKU2,500 units (serums) · 1,500 units (creams, balms)
  • MOQ — repeat run1,000 units (existing formula, validated tooling)
  • Prototype-to-fill28 calendar days (vs. 70-day category median)
  • ComplianceISO 22716 cosmetic GMP · FDA MoCRA VCRP registration
  • Label reviewINCI check, allergen declaration, claims substantiation
A laboratory bench with three serum bottles and amber glass active-ingredient containers under cool overhead lighting.
FIG. 04.1 Topical fill line at the Linden, NJ facility — airless pump assembly under ISO 22716 cosmetic GMP.
§ 05 — DELTA REPORT

Donat Mg vs. industry median.

Four metrics a procurement manager needs to defend the vendor decision in an internal review. Source: Donat Mg FY 2024 production records and a 2023 third-party benchmark of 60 North American contract manufacturers.

METRIC DONAT MG INDUSTRY MEDIAN DELTA VERIFICATION
Prototype-to-capsule turnaround 14 days 45 days − 31 days DMG FY24, n=412 briefs
Minimum order quantity (capsules) 5,000 units 12,500 units − 60% RFQ review log, 2024
Inline NIR potency verification Included on every batch Add-on, $0.08/unit avg Standard, no upcharge DMG batch records (SciAps log)
On-time delivery (trailing 12 mo) 99.4% 87.5% + 11.9 pts Q1–Q4 2024 shipping log
ISO 22716 cGMP 21 CFR 111 NSF GMP for Sport QAI Organic
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