In 2013, the Nobel Prize in Physiology or Medicine established the cellular “vesicle trafficking” mechanism—essentially the instruction manual for how cells package and deliver signals. That insight helps us understand and modulate exosome formation and release, opening possibilities in skin and aesthetic care. Exosomes have since been widely explored as one of the most promising ways to break long-standing bottlenecks in regeneration and repair.
TL;DR
A DMF (Drug Master File) is a confidential technical dossier submitted by a raw-material manufacturer to the U.S. FDA so that a drug applicant can reference it during regulatory review.
It proves the material’s data and quality files are on record and traceable—it does not mean any product or claim has been approved by a regulator.
Our products are cosmetics/personal care used on the skin surface. We disclose DMF-related facts on our “Credentials & Compliance” page as part of supply-chain transparency.
01｜DMF in one line
DMF = a confidential, regulator-held “instructions & data pack” for a raw material.
Typical contents (high-level): origin & overview, manufacturing and quality controls (CMC), impurity limits, stability & storage/transport, microbial/endotoxin safety. It sits on file at FDA and can be reviewed during a drug submission via a Letter of Authorization (LoA) from the DMF holder. The full DMF is not public.
What it means for you: the upstream supplier maintains standardized technical & quality documentation that can be referenced and audited in regulated contexts.
02｜How does a DMF relate to
cosmetics approval
?
It doesn’t, directly.
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A DMF exists to support drug submissions (data referencing).
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Cosmetics follow a different regulatory path (e.g., INCI labeling, safety assessment, market-specific notification/registration).
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Therefore, “has a DMF” ≠ “FDA approved cosmetic” and ≠ any efficacy/medical approval.
On our site, you’ll see clear wording: “DMF/INCI indicate documentation and traceability; they are not efficacy approvals.”
03｜So why do we still highlight DMF?
Three concrete reasons:
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Traceable: Together with our per-vial label (LOT / Vial-ID / QR) and Trace Page, it links each vial to its batch COA summary.
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Auditable: For B2B/clinic partners, we can—under NDA—enable LoA-based regulatory viewing (without disclosing the entire DMF).
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Future-ready: If a partner explores higher-regulation product pathways later, the documentation backbone can align without starting from zero.
04｜How this ties into our delivery promise—making “fresh & verifiable” tangible
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Fresh-Batch 48h: ship within 48 hours of order.
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Per-vial labeling: LOT / Vial-ID / date / spec / storage printed on each vial.
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Batch COA summary on your Trace Page: size/distribution (e.g., NTA), marker proteins (e.g., CD9/CD63/CD81), bioburden/endotoxin, pH/osmolality/appearance/stability snapshot.
DMF on file + batch release testing + per-vial traceability = our closed loop of “verifiable transparency.”
05｜Quick FAQ
Q: If there’s a DMF, can I say “FDA certified/approved”?
A: No. DMF ≠ approval. It means documentation on file, not that a cosmetic is FDA-approved or that any medical efficacy is endorsed.
Q: Can I see the full DMF?
A: Not publicly. For qualified partners, LoA-based review is possible under confidentiality.
Q: As a consumer, what’s the practical benefit?
A: It underpins traceability. Each vial you receive can be linked to source & quality docs via the Trace Page, with COA summaries and shipping temperature notes.
Q: Are your cosmetics directly “regulated via the DMF”?
A: No. Cosmetics follow cosmetic regulations. A DMF simply demonstrates upstream documentation discipline—useful for audits and supply-chain due diligence, not a cosmetic claim approval.
One-line wrap
A DMF makes materials “documented and reviewable,” not “approved for claims.”
At EXOPUREBEAUTY, you get the trio that matters: the latest released batch, per-vial traceability, and batch QC summaries—so freshness, transparency, and verification live on every bottle you open.
Compliance & scope note (site-wide reusable)
Our products are cosmetics intended for surface-level skincare—hydration, soothing, and supporting the skin barrier. They are not intended to diagnose, treat, cure, or prevent any disease. Any research/case materials shared on-site are for educational context only and do not constitute individual performance guarantees or medical advice. Always follow professional guidance for in-clinic procedures and aftercare.
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