01 / PEOPLE
86
employees across R&D, Quality, Regulatory, and Operations — including 11 PhD chemists and 4 registered dietitians on staff, not contracted.
- PhD chemists11
- Registered dietitians4
- Regulatory specialists9
- QA / QC analysts14
CONTRACT MANUFACTURING • LINDEN NJ • RENO NV
A scientist-led contract manufacturer building retail-ready supplements in 14 days from two U.S. cGMP facilities.
Donat Mg is a U.S.-based contract manufacturer specializing in encapsulated supplements, gummy nutraceuticals, and cosmeceutical skincare. We turn founder-led brands into retail-shippable products with ISO 22716 and cGMP compliance baked in from the first gram.
- 84,000sq ft · 2 sites
- 11PhD chemists
- 28FDA NDIN clearances
- 99.4%on-time delivery
- 14days · prototype to capsule
FOUNDER STORY
Founded in 2014 by Dr. Magdalena Donat after a decade formulating at Pfizer — built for founders who refuse to ship a substandard capsule.
Magdalena left a senior formulation role at Pfizer in 2013 with one conviction: the supplement aisle had become a graveyard of under-dosed, mis-labeled product, and the brands funding it deserved a manufacturing partner that thought like a scientist first. She opened a 9,000 sq ft lab in Linden with two former colleagues, a single encapsulator, and a Quality Manual she had written herself.
A decade later, that lab is one of two cGMP-certified facilities totaling 84,000 sq ft across Linden, NJ and Reno, NV — staffed by 86 employees including 11 PhD chemists and 4 registered dietitians, and shipping 2.1 million finished units a year across 47 SKUs for 140+ venture-backed brands. The Quality Manual is now in its eleventh revision, but the founding rule has not changed: a capsule goes out only when the potency, the label, and the regulatory file are the same number.
- Founded2014 · Linden, NJ
- Previous10 yrs @ Pfizer · Formulations
- Employees86 across R&D, QA, Operations
- PhD chemists11 on staff
- Dietitians4 registered · regulatory desk
FROM THE LAB NOTEBOOK · DR. M. DONAT
“Speed and compliance are not a trade-off. The fastest batch I have ever shipped cleared the FDA on the first review — because every gram was specified, every assay was pre-registered, and the label said exactly what the capsule contained.”
— Dr. Magdalena Donat, on the Donat Mg Quality Manual
TEAM & FACILITIES
The team, certifications, and physical footprint behind every batch.
Every number below is a purchase-order line a procurement manager can verify against the certificate binder we ship with each lot. Nothing is aspirational.
02 / FACILITIES
84,000 sq ft
Two cGMP-certified sites, fully owned and operated — no shared cleanrooms, no co-mingling of client lines.
- Linden, NJ · HQ & Encapsulation52,000 sq ft
- Reno, NV · Gummy & Cosmeceutical32,000 sq ft
- Encapsulation lines6
- Gummy depositing lines3
03 / THROUGHPUT
2.1M units · 2024
Finished units shipped across 47 SKUs in FY 2024, with a 99.4% on-time delivery rate over the trailing twelve months.
- On-time delivery99.4%
- SKUs shipped47
- Avg. days to first batch28
- Avg. prototype lead14 days
04 / REVENUE
$34.2M FY 2024
Up 71% year over year, with capital reinvested into both facilities — not into consumer marketing you will never see.
- YoY growth+71%
- Active brand clients140+
- NDIN / claim approvals · 202428
- Label reviews · zero warning letters412
CERTIFICATIONS & AWARDS
Every certification, registration, and award an enterprise procurement team will ask for.
Send this page to your vendor-qualification team. Each line links to a current certificate PDF on request — including scope of accreditation, last audit date, and the issuing registrar.
A · COMPLIANCE
Regulatory certifications
- ISO 22716
- cGMP · 21 CFR Part 111
- NSF GMP for Sport
- Organic QAI
B · REGISTRATIONS
FDA & state filings
- FDA Facility Registration
- NDIN clearances · 2024
- Structure/function claims
- FDA warning letters
C · AWARDS
Industry recognition
- Contract Manufacturer of the Year
- Top 10 Private Label Manufacturers · North America
- FDA Inspection Record
- Vendor of the Year
D · FOR YOUR QA TEAM
Send the binder in one email.
Quality Manual, last ISO surveillance audit, NDIN roster, insurance certificates, and a redacted CofA from a comparable run — packaged and on the way within one business day.
Request the QA BinderFREE FOR FORMULATORS
A free 12-step ingredient sourcing library used by 6,300+ formulators — and how to access it.
We open-sourced the same vendor-qualification workflow our procurement team runs for every new ingredient we spec. Twelve steps, four downloadable worksheets, no email gate beyond a single confirmation message. It is the most useful thing on this page.
No subscription. Used by R&D teams at 6,300+ brands, schools, and indie labs worldwide.
- 01Define the claim, the dose, and the contraindication envelope.
- 02Shortlist ingredients by mechanism, not by marketing copy.
- 03Verify GRAS / NDIN status for every component at the target dose.
- 04Audit suppliers — audit reports, allergen statements, country of origin.
- 05Request spec sheets & CoA for at least three production lots, not one.
- 06Cross-check heavy-metal and microbial limits against USP / FCC.
- 07Decide format — capsule, gummy, powder, liquid — against shelf-life targets.
- 08Run a 5 kg bench batch before committing to a 50 kg pilot.
- 09Validate potency via HPLC, NIR, or third-party — never trust a vendor PDF.
- 10Lock the label: Supplement Facts, allergens, structure/function claim language.
- 11File your FDA notification letter 30 days before launch.
- 12Hold retain samples — we keep yours for three years, you keep yours forever.