CAS 544-31-0 FSSAI approved Made in India NLT 98% assay N · M · CWD grades

The palmitoylethanolamide your formulation was supposed to have.

Fully characterized, particle-size-controlled and documented like a pharmaceutical raw material — without the European price tag that normally comes attached. Manufacturing in India is how both are true at once.

Request a 100 g sample Grades & specifications

— Full CoA with every batch — Laser-diffraction PSD on every lot — Regulatory dossier on request

Palmitoylethanolamide

IUPAC N-(2-hydroxyethyl)hexadecanamide
CAS 544-31-0
EC number 208-867-9
Formula C₁₈H₃₇NO₂
Molecular weight 299.49 g/mol
Class N-acylethanolamine (ALIAmide)
Primary target PPAR-α
Appearance White crystalline powder

98%

Minimum assay by HPLC on the dried basis, every grade.

3,300+

Indexed scientific publications on palmitoylethanolamide.¹

Randomized controlled trials in the 2025 pain meta-analysis.²

≤10 µm

D₉₀ target for the PEAOID micronized grade, measured on every lot.

Why PEAOID

Most PEA on the market is sold on a CAS number. Ours is sold on a data package.

Palmitoylethanolamide is a poorly water-soluble lipid amide. Purity alone does not determine how it performs in a finished dose — particle size, crystal habit and dispersion do. PEAOID controls and documents all of them.

Particle size is a specification, not a slogan

Every lot ships with a laser-diffraction particle-size distribution — D₁₀, D₅₀, D₉₀ — against a defined range. You can hold us to a number, not an adjective.

Why particle size matters

A documentation pack that survives audit

Specification, analytical method summary, batch CoA, heavy metals, residual solvents, microbiology, allergen and BSE/TSE statements, stability data and MSDS — issued as a set, not on request.

Inside the quality system

Vegan by origin, not by exception

PEAOID is manufactured from a natural, plant-derived starting material. No animal-origin inputs and no animal-derived processing aids at any stage, so the finished ingredient supports vegan and vegetarian claims on your pack without a caveat.

How PEAOID is made

FSSAI approved, valid Form II

Approvals under India’s Non-Specified Food route are granted to a named applicant — not to the ingredient. Plenty of suppliers quote a file number that belongs to somebody else. Ours is held in our own name, and the Form II reference comes with the dossier.

Regulatory by market

The range

Three grades. One molecule. Very different dissolution behavior.

Normal, micronized and cold water dispersible. Choose by dosage form and by how much of the label dose has to actually dissolve — we will tell you honestly when the cheaper grade is the right answer.

PEAOID / N

Normal

Unmicronized crystalline PEA. The reference material and the economic choice for high-dose powders, sticks and applications where the finished dose is dispersed before it is swallowed.

Typical D₅₀≈ 100–200 µm

Assay NLT 98.0% (HPLC)
Lowest cost per kilogram
Excellent flow, low static
Bulk powders, sachets, veterinary premix

Full specification

Most specified PEAOID / M

Micronized

Jet-milled to the particle-size window used in the majority of published human PEA studies. This is the grade most finished-brand buyers mean when they say “micronized PEA” on-pack.

Target D₉₀≤ 10 µm · D₅₀ 2–6 µm

Assay NLT 98.0% (HPLC)
PSD by laser diffraction on every lot
Substantially faster dissolution than normal grade
Capsules, tablets, gummies, softgels

Full specification

PEAOID / CWD

Cold water dispersible

Micronized PEA carried on a dispersion system so it wets and disperses in cold aqueous media instead of floating and clumping. Made to order against a defined brief.

BehaviorDisperses in cold water

Assay NLT 85.0% (HPLC) — PEA on a dispersion carrier
Solves the wetting problem milling alone cannot
No ringing or floating in liquid formats
RTD shots, beverages, powders for reconstitution

Full specification

Straight talk

Finer is not automatically better. In beagle pharmacokinetic work, micronized and ultra-micronized PEA at 15 mg/kg produced essentially the same serum peak (22.2 vs 22.4 pmol/mL at one hour) — once particles are small enough, further reduction gives diminishing returns.³ The large, reproducible gap is between unmicronized and micronized. If your dosage form does not need UM, we will quote you M and say so.

Mechanism

A body-own lipid mediator that resets inflammatory signalling rather than blocking it.

Palmitoylethanolamide is an endogenous N-acylethanolamine, synthesized on demand in injured or stressed tissue. It is not a cannabinoid, not an NSAID and not an opioid. It works upstream, on transcription.

PPAR-α agonism — the primary, genetically validated mechanism. In PPAR-α knockout animals, PEA's anti-inflammatory effect disappears.⁴
NF-κB restraint — downstream of PPAR-α, PEA reduces nuclear translocation of NF-κB and expression of COX-2 and iNOS.⁵
ALIA — Autacoid Local Injury Antagonism: down-modulation of mast cells and glia, the concept named by Nobel laureate Rita Levi-Montalcini's group.
Entourage effect — PEA competes for FAAH, sparing anandamide, and raises 2-AG levels, indirectly potentiating endocannabinoid tone without binding CB1 or CB2 itself.⁶

Read the full mechanism How it differs from CBD

Signalling cascade

Tissue insult

NAPE-PLD cleaves membrane phospholipid precursors, releasing PEA locally — on demand, not from storage.

Nuclear receptor binding

PEA binds PPAR-α, which heterodimerizes with RXR and translocates to the nucleus.

Transcriptional shift

Pro-inflammatory gene expression falls: COX-2, iNOS, TNF-α. NF-κB nuclear translocation is suppressed.

Cellular outcome

Mast-cell degranulation and glial over-activation are restrained; TRPV1 is desensitized; endocannabinoid tone is preserved.

Clinical evidence

Seven meta-analyses. Two decades of trials. And an honest account of the gaps.

We publish the counter-evidence alongside the supporting evidence, because your regulatory and medical-affairs reviewers will find it anyway — and a supplier who has already flagged it is worth more than one who has not.

META-ANALYSIS · 2023

SMD 1.68 across 11 double-blind RCTs

Lang-Illievich et al., Nutrients. 774 patients (383 PEA / 391 control), doses 300–1200 mg/day. Pain intensity, quality of life, function and sleep all improved; side effects described as negligible.⁷

META-ANALYSIS · 2025

Effect sustained to 24–26 weeks

Viña & López-Moreno, Nutrition Reviews. 18 RCTs, 1,196 patients. SMD −0.90 at 6 weeks deepening to −1.16 at 24–26 weeks, across nociceptive, neuropathic and nociplastic pain.²

SAFETY · 2016

~1,590 patients across 16 trials

Gabrielsson et al., Br J Clin Pharmacol. For courses up to 49 days, the pooled data exclude serious adverse reactions at a rate of 1 in 200 or more. Pooled dropout ran lower on PEA than on placebo.⁸

Strength of human evidence by indication

1,196patients

Chronic pain (pooled)

Seven meta-analyses since 2016. Consistent direction of effect; reviewers flag high heterogeneity.

Strong

636patients

Sciatic nerve compression pain

Randomized, placebo-controlled. VAS 7.1 → 2.1 at 600 mg/day over three weeks; NNT of 1.5 for 50% pain reduction.⁹

Strong

111patients

Knee osteoarthritis

Double-blind, placebo-controlled, three arms. Significant WOMAC and NRS improvement at both 300 and 600 mg/day over 8 weeks.¹⁰

Strong

66patients

Diabetic peripheral neuropathy

Quadruple-blind RCT, 600 mg/day, 8 weeks. Pain severity and interference, sleep and IL-6 all improved.¹¹

Moderate

103completers

Sleep onset

Double-blind RCT, 350 mg before bed. Reduced sleep-onset latency in those with baseline latency over 10 minutes; overall PSQI not significantly different.¹²

Emerging

100animals

Canine & feline joint pain

Double-blind, placebo-controlled, 50 dogs and 50 cats over 6 weeks. 76% of dogs classed as successfully treated vs 40% on placebo.¹³

Moderate

What the evidence does not yet show

A 2016 randomized, double-blind trial of ultra-micronized PEA in spinal-cord-injury neuropathic pain (n = 73) was negative on its primary endpoint.¹⁴ A 2017 carpal tunnel trial at 600 mg/day was largely negative on clinical and electrophysiological measures.¹⁵ A 2022 systematic review found that when the analysis was restricted to the randomized trials alone, the pooled effect lost significance.¹⁶ Heterogeneity across the pain literature is high (I² 95–99%) and a large share of the positive data is Italian and open-label. PEA is a well-supported ingredient. It is not a finished drug, and we will not sell it as one.

Open the full evidence library Dose ranges used in trials

Applications

Where PEAOID goes

PEA is a neutral-tasting, heat-stable crystalline powder with no significant color contribution. It formulates cleanly across most oral formats and into topicals.

Capsules & tablets

The dominant global format. 300, 400 and 600 mg per unit are the established consumer dose points.

Gummies & chews

Micronized grade disperses well in pectin and gelatin matrices. No bitterness carried into the finished chew.

Stick packs & sachets

Higher payload per serving with a fast-melt or effervescent base. Normal grade is often sufficient here.

RTD shots & beverages

Requires a dispersion or emulsification system. We advise on wetting agents and carrier selection.

Neuro & sleep stacks

Combines cleanly with luteolin, melatonin, magnesium and B-vitamins. Co-milled blends available.

Joint & mobility

Formulated alongside glucosamine, collagen peptides, boswellia and curcuminoids in both human and pet lines.

Companion animal

A fast-growing category with its own controlled trial data in dogs and cats. Palatable powder and soft-chew grades.

Topicals

Lipophilic and stable in oil-phase systems. Used in balms, creams and post-procedure skin formats.

Formulation guidance by format

Quality

What arrives with the drum.

A qualification pack that lets your QA team open a supplier file the same week, not the same quarter.

Quality & manufacturing

Document	Scope
Product specification	All release parameters with limits and methods
Certificate of analysis	Batch-specific results including full PSD
Analytical method summary	HPLC assay, FTIR and NMR identity, GC residual solvents
Heavy metals report	Pb, As, Cd, Hg by ICP-MS
Microbiological report	TPC, yeast & mould, E. coli, Salmonella
Residual solvents	Against ICH Q3C class limits
Allergen & BSE/TSE statement	Declaration of absence, animal-origin free
Vegan / non-GMO declaration	Feedstock and processing-aid origin
Stability data	Real-time and accelerated, retest period justification
Safety data sheet	GHS-format MSDS
Flow chart & origin	Process flow, country of origin, HS code

Additional market-specific documentation available on request. Retention samples held for the full retest period.

Regulatory

Where palmitoylethanolamide can be sold today

Status differs sharply by market. This is our reading of the public record — verify it against your own regulatory counsel before you commit to a launch.

Market	Framework	Position
India	FSSAI	FSSAI approved with a valid Form II, under the Non-Specified Food & Food Ingredients Regulations.¹⁷ Approval under this route is applicant-specific — ours is held in our own name, not borrowed from a third party.
Australia / NZ	TGA	Permitted active in listed medicines; multiple PEA products carry ARTG entries.¹⁸
Canada	Health Canada NHP	Multiple licensed natural health products containing PEA carry NPNs.
Italy	FSMP / supplement	The most mature market. Long-marketed as a food for special medical purposes; also permitted in food supplements.
United States	DSHEA	Marketed as a dietary-supplement ingredient. Self-affirmed GRAS dossiers exist; we are not aware of an FDA-issued GRAS notice for PEA.
European Union	Novel food	No EU-wide novel food authorization has been confirmed. Position varies by member state — check nationally.

Summary only, current as at July 2026. Regulatory status changes; PEAOID does not warrant the position in any market and buyers remain responsible for compliance in the territory of sale.

Full market-by-market detail

Who we supply

Built for the people who have to defend the choice internally

Nutraceutical brands

Branded finished products in pain, joint, sleep, nerve comfort and healthy-ageing positioning. Trade-mark-free ingredient — your brand story stays yours.

Contract manufacturers

Reliable lead times, consistent PSD lot to lot, and documentation that clears incoming QA without a chase.

Distributors & importers

Territory arrangements, stocking programs, drop-shipment and the regulatory dossier needed to register locally.

Veterinary & pet nutrition

An under-served category with genuine controlled data. Palatable grades and soft-chew-compatible particle sizes.

100 g and 1 kg samples 1, 5 and 25 kg packs Double PE liner, HDPE drum 36-month retest period Worldwide air & sea freight NDA on request

Common questions

Answered plainly

Three. Normal (PEAOID / N) is unmilled crystalline PEA. Micronized (PEAOID / M) is milled to a D₅₀ of roughly 2–6 µm with D₉₀ not more than 10 µm — the particle-size class used in most published human PEA work. CWD (PEAOID / CWD) is cold water dispersible, for liquid formats. Every lot ships with its measured distribution, so you never take the word “micronized” on trust.

The commercial minimum order quantity is 30 kg. Evaluation samples of 100 g are supplied on a chargeable basis against a qualified enquiry. Larger contract volumes are quoted against an annual forecast — tell us your yearly requirement and we will price the tier rather than the trial.

PEAOID is. The molecule occurs naturally in both plant and animal tissue — soy lecithin, peanut meal and egg yolk are the classical dietary sources — but commercial PEA is produced synthetically, by condensing palmitic acid with ethanolamine. We use vegetable-derived palmitic acid and no animal-origin processing aids, so the material is suitable for vegan finished products. The capsule shell is your decision, not ours.

Yes. Co-processed and co-milled combinations — PEA with luteolin, with polydatin, or with a dispersion system for beverage applications — are available on a contract basis with a defined development lead time. Send us the target ratio and the dosage form and we will come back with a feasibility view.

PEAOID is a raw-material brand. We work with contract manufacturers in India and abroad and can introduce you to a suitable partner for finished-dose production, but the ingredient specification and its documentation are our product.

Samples generally leave within two working days of the enquiry being qualified. Commercial lots depend on grade and volume; normal and micronized grades are normally held in stock, ultra-micronized and co-milled blends are made to order. We give a firm date with the quotation rather than an optimistic range.

All 40 questions

References

Europe PMC literature search, “palmitoylethanolamide”, all sources, retrieved July 2026. europepmc.org
Viña I, López-Moreno M. Meta-analysis of palmitoylethanolamide in pain management. Nutrition Reviews 2025;83(7):e1604–e1618. doi:10.1093/nutrit/nuae203
Della Valle F, et al., comparative canine pharmacokinetics of micronized and ultra-micronized PEA, 2013; summarized in Beggiato S, Tomasini MC, Ferraro L. Front Pharmacol 2019;10:821.
LoVerme J, et al. The nuclear receptor PPAR-α mediates the anti-inflammatory actions of palmitoylethanolamide. PMID 15465922
Central administration of PEA reduces hyperalgesia via inhibition of NF-κB nuclear signalling in dorsal root ganglia. PMID 19386271
Petrosino S, et al. PEA enhances 2-arachidonoylglycerol levels and potentiates its actions at TRPV1. Br J Pharmacol 2016. PMID 25598150
Lang-Illievich K, et al. PEA in the treatment of chronic pain: a systematic review and meta-analysis of double-blind RCTs. Nutrients 2023;15(6):1350. mdpi.com
Gabrielsson L, Mattsson S, Fowler CJ. Palmitoylethanolamide for the treatment of pain: pharmacokinetics, safety and efficacy. Br J Clin Pharmacol 2016. PMID 27220803
Keppel Hesselink JM, Kopsky DJ. Palmitoylethanolamide, a neutraceutical, in nerve compression syndromes. J Pain Res. dovepress.com
Steels E, et al. A double-blind randomized placebo-controlled study of PEA for symptoms of knee osteoarthritis. Inflammopharmacology 2019;27(3):475–485.
Pickering E, et al. A randomized controlled trial of PEA for diabetic-related peripheral neuropathic pain. Inflammopharmacology 2022;30(6):2063–2077. PMID 36057884
Rao A, et al. Palmitoylethanolamide for sleep disturbance: a double-blind, randomized, placebo-controlled study. Sleep Science and Practice 2021.
Levagen+ alleviates joint pain in canines and felines: a double-blind, placebo-controlled RCT. Front Vet Sci 2026.
Andresen SR, et al. Ultramicronized PEA in spinal cord injury neuropathic pain: a randomized, double-blind, placebo-controlled trial. Pain 2016;157(9):2097–2103. PMID 27227691
Faig-Martí J, Martínez-Catassús A. Use of PEA in carpal tunnel syndrome: a prospective randomized study. J Orthop Traumatol 2017. PMID 28299455
Scuteri D, et al. Effects of PEA on nociceptive, musculoskeletal and neuropathic pain: systematic review and meta-analysis. Pharmaceutics 2022;14(8):1672.
Food Safety and Standards Authority of India, Status of Non-Specified Food applications. fssai.gov.in
Therapeutic Goods Administration, Australian Register of Therapeutic Goods. tga.gov.au

Next step

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