What is the minimum order quantity for a first production run?

Donat Mg starts new clients at 5,000 units — roughly 60% below the 12,500-unit category standard — so indie founders and venture-backed brands can both fit a launch batch into working capital.

How fast can a prototype formula move to a shippable batch?

First shippable batches typically ship within 28 days of contract signing, with the prototype-to-capsule phase closing inside 14 days for most encapsulated and gummy formats.

Which product formats does Donat Mg manufacture?

Donat Mg specializes exclusively in encapsulated dietary supplements, gummy nutraceuticals, and cosmeceutical skincare — all produced at ISO 22716- and cGMP-certified facilities.

What regulatory support is included with manufacturing?

An in-house regulatory team handles label compliance reviews, structure/function claim vetting, and NDIN preparation; the team has completed 412 label reviews with zero FDA warning letters since 2019.

CONTRACT MANUFACTURING · LINDEN NJ · RENO NV

Precision contract manufacturing for encapsulated supplements, gummies, and cosmeceuticals — first retail-shippable batch in 14 days.

Name: Donat Mg
Address: 1420 Pierce Street, Linden, NJ, 07036, US
Telephone: +1 (908) 555-0142

Donat Mg is a U.S.-based contract manufacturer founded in 2014 by Dr. Magdalena Donat, a former Pfizer formulation scientist. We shipped 2.1 million finished units across 47 SKUs in 2024 from 84,000 sq ft of ISO 22716 and cGMP-certified space.

BOOK A FREE FORMULATION CONSULT VIEW CAPABILITIES

14DAYS · PROTOTYPE TO CAPSULE
99.4%ON-TIME DELIVERY · TRAILING 12 MO
5,000UNIT MOQ · 60% BELOW CATEGORY

COMPLIANCE · AUDIT TRAIL

Operates inside the regulated frameworks procurement and PE buyers require before initiating a manufacturer conversation.

ISO 22716Cosmetic GMP · audited annually
cGMP · 21 CFR PART 111Dietary supplement manufacturing
NSF GMP FOR SPORTBanned-substance screened facility
ORGANIC · QAICertified organic handling
28 NDINActive New Dietary Ingredient notifications on file (2024)
0 LETTERSFDA warning letters since 2019 across 412 label reviews

SPECIFICATIONS · NOT SLOGANS

Eight measurable competitive edges. The four founders ask about first, on a single page.

Each tile is a verifiable data point backed by audit logs, shipment manifests, or FDA filings — not marketing language.

01 / SPEED

14-day prototype-to-capsule turnaround.

3.2× faster than the 45-day industry median. Average new client produces a first retail-shippable batch within 28 days of contract signing.

MEDIAN: 45 DAYS
DONAT MG: 14 DAYS

02 / REGULATORY

28 active NDIN and structure/function claim approvals on file with the FDA in 2024.

In-house regulatory team has cleared 412 label compliance reviews with zero FDA warning letters since 2019.

NDIN: 28 ACTIVE
WARNING LETTERS: 0

03 / FOOTPRINT

Two cGMP-certified facilities · 84,000 sq ft total.

Linden, NJ and Reno, NV — dual-coast redundancy for U.S. distribution without transoceanic freight risk.

LINDEN NJ: 42,000 SQ FT
RENO NV: 42,000 SQ FT

04 / VERIFICATION

Inline NIR spectroscopic potency verification as standard.

The first private-label manufacturer to include near-infrared potency checks on every capsule run — no upcharge, no addendum.

METHOD: NIR · INLINE
UPCHARGE: $0

+ FOUR MORE VERIFIED EDGES:

5,000-unit MOQ (60% below category), 140+ venture-backed DTC clients, Contract Manufacturer of the Year — NutraIngredients Awards 2023, and a free 12-step ingredient sourcing library used by 6,300+ formulators worldwide.

SEE FULL CAPABILITY DOSSIER →

PROJECT CADENCE · 28 DAYS, CONTRACT TO BATCH

From formulation brief to shippable pallet, with named owners and dated milestones.

DAY 01 → 04
Formulation brief

Head of R&D and a senior chemist review the brief, lock ingredient sourcing, and issue a stability-forecasted master formula.
OWNER · R&D LEAD
DAY 05 → 10
Sample shipment

Three pilot samples shipped for sensory, dissolution, and accelerated-stability evaluation against your claim structure.
OWNER · R&D LEAD
DAY 11 → 18
Pilot batch + regulatory sign-off

Pilot run on the production line, NIR potency check, and label compliance review by in-house regulatory team.
OWNER · REGULATORY + PRODUCTION
DAY 19 → 28
Production runs

Full production run, finished-unit QC, palletization, and release documentation handed to your 3PL or direct to distribution.
OWNER · PRODUCTION

READ THE FULL PROCESS MAP

CAPABILITIES · HARD LIMITS

Three product formats. Hard caps on dosage, batch size, and compliance scope so you can self-qualify before the call.

Encapsulated supplements

Vegetable and gelatin two-piece capsules, bead-filled hard caps, and time-release matrices.

THROUGHPUT: 240,000,000 CAPSULES / YR
DOSE RANGE: 100 MG – 1,200 MG
BATCH SIZE: 5,000 – 1,200,000 UNITS
VERIFICATION: INLINE NIR · STANDARD
COMPLIANCE: cGMP · 21 CFR 111 · NSF SPORT

CAPSULE LINE DETAILS →

Gummy nutraceuticals

Pectin and gelatin gummies with active nutraceutical load, low-sugar bases, and pH-stable flavor systems.

THROUGHPUT: 60,000 GUMMIES / SHIFT
DOSE RANGE: 25 MG – 500 MG ACTIVE
BATCH SIZE: 10,000 – 800,000 UNITS
VERIFICATION: HPLC POTENCY · STANDARD
COMPLIANCE: cGMP · 21 CFR 111 · ORGANIC QAI

GUMMY LINE DETAILS →

Cosmeceutical skincare

Serums, creams, and balms formulated for cosmetic claims with rigorous microbiological and stability testing.

THROUGHPUT: 120,000 UNITS / SHIFT
FILL VOLUME: 5 ML – 250 ML
BATCH SIZE: 2,500 – 500,000 UNITS
SUITES: ISO 22716 DEDICATED ROOMS
COMPLIANCE: ISO 22716 · CTFA LABEL REVIEW

SKINCARE LINE DETAILS →

FOUNDER FIELD NOTES

What it actually feels like to ship a first SKU with us — from two founders who did.

SERIES A · DTC

“We had a board deadline and a co-packer who couldn't get us a stability sample in six weeks. Donat Mg shipped our first runnable pilot inside ten days and the production batch cleared regulatory in twenty-eight.”

SPEED-TO-SHELF: 28 DAYS
UNITS SHIPPED: 240,000

FIRST SKU · INDIE

“I needed 5,000 units, not 50,000. Every other manufacturer laughed me off the call. Donat Mg's 5,000-unit MOQ let me prove the SKU before I raised. We're now on our fourth reorder.”

FIRST BATCH: 5,000 UNITS
REORDERS: 04 TO DATE

Trusted by 140+ venture-backed DTC brands including alumni spinouts from Hims, Moon Juice, and Ritual.

DIRECT LINE · HEAD OF R&D

Book a 30-minute formulation consult with Dr. Magdalena Donat. No pitch deck, no sales engineer — the formulator, the chemist, and the FDA-compliance lead.

We'll review your brief, your target SKU, and your regulatory exposure on the call. You leave with a feasibility range, a sample plan, and a written quote within 72 hours.

BOOK A FREE FORMULATION CONSULT

OR REACH THE LAB DIRECTLY [email protected] +1 (908) 555-0142 1420 Pierce Street, Linden, NJ 07036 · 84,000 sq ft · Est. 2014