FSSAI-approved palmitoylethanolamide · manufactured in India · shipped worldwideFSSAI-approved PEA · made in India Request a sample WhatsApp 7409849603 info@aurorafarmabio.com
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Frequently asked questions

Forty questions, answered without hedging.

Commercial, technical, scientific and regulatory. Where the honest answer is “we could not confirm that”, that is the answer you will find.

Commercial & supply

The commercial minimum order quantity is 30 kg. Evaluation samples of 100 g are available on a chargeable basis against a qualified business enquiry. Larger volumes are quoted against an annual forecast rather than a single purchase order.

Yes, on a chargeable basis. A 100 g evaluation sample is supplied against a qualified business enquiry — we need to know the company, the intended dosage form and roughly the volume you are working toward. Larger pilot quantities are arranged case by case.

Samples generally despatch within two working days. Normal and micronized grades are normally held in stock and ship within a week of order confirmation. CWD and co-milled grades are made to order, typically three to five weeks. We quote a firm date rather than a range.

A double heat-sealed food-grade LDPE liner inside an HDPE or fiber drum, tamper-evident, in 1 kg, 5 kg and 25 kg pack sizes. Labelled with product, grade, batch number, manufacture and retest dates, net weight and storage conditions.

A 36-month retest period from date of manufacture, stored below 25 °C in the original closed packaging, protected from light and moisture. Stability data supporting the retest period is part of the qualification pack.

EXW, FOB, CIF and DDP by agreement. For first orders into a new market we usually recommend CIF so that documentation and clearance are handled with the shipment rather than after it.

Yes, a mutual NDA on request, normally turned round within one business day. Sign it before you tell us anything about your formulation, brand or launch timing — we would rather you did.

The ingredient can be supplied in neutral packaging, and we do not require the PEAOID name to appear on your finished pack. There is no trade-mark license fee and no ingredient-brand tax on your label.

No. PEAOID is a raw-material brand. We can introduce you to contract manufacturers in India and abroad who work with our material, but we do not compete with our own customers in finished goods.

Territory arrangements are possible against a committed annual volume and a defined market-development plan. Tell us the territory and the forecast and we will discuss it seriously.

Technical & formulation

Three. PEAOID / N is normal unmilled crystalline PEA. PEAOID / M is micronized to a D50 of roughly 2-6 microns with D90 not more than 10 microns - the particle-size class used in the majority of published human PEA work. PEAOID / CWD is a cold water dispersible grade: micronized PEA carried on a dispersion system so it wets in cold aqueous media instead of floating, specified at NLT 85% PEA content. Every lot ships with its measured particle-size distribution.

Particle size, and therefore dissolution rate. PEA is practically insoluble in water, so absorption is limited by how quickly the crystal dissolves. The large, well-evidenced step is from unmicronized to micronized. Beyond that, comparative canine pharmacokinetics found micronized and ultra-micronized produced near-identical serum peaks at the same dose, so choose UM for the dosage form and the positioning rather than expecting a further bioavailability jump.

Not less than 98.0% by HPLC on the dried basis for the normal and micronized grades. The cold water dispersible grade is specified at not less than 85.0% PEA content - the balance is the dispersion system that makes it wet in cold water rather than float. The certificate of analysis carries the actual measured figure for the lot, not the specification limit.

Three ways: HPLC retention time against a reference standard, FTIR spectral concordance, and structural confirmation by proton NMR. All three are documented in the analytical method summary.

PEAOID is. Palmitoylethanolamide occurs naturally in both plants and animals, and it is produced commercially rather than extracted. PEAOID is manufactured from a natural, plant-derived starting material, with no animal-origin inputs and no animal-derived processing aids at any stage, so the material supports vegan and vegetarian finished-product claims. A written declaration is issued with the qualification pack.

Yes on both counts, with written declarations. The synthesis does not use soy, peanut, egg or any of the major allergens as an input, notwithstanding that those foods happen to contain PEA naturally.

Yes. There is no cereal input in the synthesis and the declaration is part of the qualification pack.

Yes, on a contract basis with a defined development lead time. Co-milling to a shared particle-size distribution is meaningfully different from dry blending two powders, and the European clinical literature on PEA-luteolin and PEA-polydatin uses co-processed material.

Only with a dispersion or emulsification system. Unmodified PEA powder is hydrophobic and will float and ring the neck of the bottle. Our PEAOID / D dispersible grade is designed for this; specify the beverage system and we will advise.

Yes, with a caveat. The melting range is 95–101 °C, so add PEA after the cook step, below 90 °C, into a well-agitated slurry. Micronized grade suspends evenly; normal grade tends to sediment in the depositor.

Usually size 0 for micronized grade and size 00 for ultra-micronized, because milled PEA has a low bulk density. We provide bulk and tapped density data with the specification so your encapsulation team can size the shell before the material arrives.

It is a simple fatty-acid amide with no ionisable groups at physiological pH, and no meaningful incompatibility has been reported with common vitamins, minerals or botanical extracts. It is not chemically fussy.

Essentially none at label doses. It is odorless to faintly characteristic and effectively tasteless. Any off-note in a finished product is almost always coming from something else in the matrix.

Yes, real-time and accelerated data supporting the 36-month retest period, supplied with the qualification pack. Customer-specific stability studies on a finished matrix can be arranged separately.

An endogenous N-acylethanolamine — the amide of palmitic acid and ethanolamine — produced on demand by cells throughout the body in response to injury or stress. It was first isolated from egg yolk in 1957 and acts principally as an agonist at the nuclear receptor PPAR-alpha.

Science, efficacy & safety

Primarily by activating PPAR-alpha, a ligand-activated transcription factor. That suppresses NF-kappaB nuclear translocation and reduces expression of COX-2, iNOS and pro-inflammatory cytokines. Secondary actions include down-modulation of mast cells and glia (the ALIA mechanism), TRPV1 desensitization, and indirect potentiation of endocannabinoid tone through competition for FAAH.

No. PEA does not bind CB1 or CB2 receptors and has no psychoactivity. It influences the endocannabinoid system indirectly, mainly by competing for the enzyme that degrades anandamide. It is endocannabinoid-adjacent, not a cannabinoid, and it carries none of the regulatory complexity that cannabis-derived ingredients do.

The clinical literature converges on two to six weeks for meaningful effect, still deepening at eight to twelve. This follows from the mechanism: transcriptional changes are inherently slower than enzyme inhibition. A 2024 meta-analysis found roughly 60% of total pain reduction in month one and a further clinically meaningful reduction between day 30 and day 60.

Most commonly 300 to 1,200 mg per day. 600 mg per day, given as 300 mg twice daily, is the most frequently used regimen. Some protocols load at 1,200 mg per day for the first month and step down to 600 mg for maintenance. Up to 1,800 mg per day was used in the historical respiratory program and reported as well tolerated.

The safety record is unusually good. A GLP-compliant rat developmental toxicity study established a NOAEL above 1,000 mg/kg/day, the highest dose tested. A review of 16 trials covering roughly 1,590 patients concluded that for courses up to 49 days the data exclude serious adverse reactions at 1 in 200 or more. Pooled dropout ran lower on PEA than on placebo.

Infrequent and mild where reported: occasional gastrointestinal discomfort, transient drowsiness, headache, isolated reports of palpitations. In several trials the adverse-event rate on PEA was lower than on placebo.

No pharmacokinetic drug-drug interaction studies have been published. PEA has been used alongside tramadol, pregabalin, gabapentin and duloxetine in trials without reported adverse interaction. A theoretical interaction with fibrate PPAR-alpha agonists has been raised on mechanistic grounds but not demonstrated clinically.

No. PEA is not a cannabinoid, is not structurally related to THC, and is not screened for on any standard drug panel.

Yes, and we publish it. A 2016 randomized trial in spinal-cord-injury neuropathic pain (n = 73) was negative on its primary endpoint. A 2017 carpal tunnel trial at 600 mg/day was largely negative. A 2022 systematic review found that restricting the analysis to randomized trials alone caused the pooled effect to lose significance. Heterogeneity across the pain literature is very high.

There is no single authoritative total. The 2016 safety review covered about 1,590 patients across 16 trials; the 2025 pain meta-analysis covered 1,196 across 18 RCTs; the 1972–77 Impulsin respiratory program covered 3,627 subjects, of whom 1,937 received PEA. Adding across the whole literature without double-counting gives a figure in the low thousands, but we would rather cite the individual reviews than a number nobody has published.

This is where the evidence is strongest. A randomized placebo-controlled trial in 636 patients with sciatic nerve compression pain found VAS falling from 7.1 to 2.1 at 600 mg/day over three weeks, with a number-needed-to-treat of 1.5 for 50% pain reduction. A separate quadruple-blind trial in diabetic peripheral neuropathy at 600 mg/day found significant improvement in pain severity and interference. That said, the negative spinal-cord-injury trial shows the effect is not universal across all neuropathic pain states.

Yes, and there is controlled evidence for it. A double-blind placebo-controlled trial in 50 dogs and 50 cats found 76% of dogs classed as successfully treated versus 40% on placebo, with significant improvement in feline mobility and pain scores. Ultra-micronized PEA is already stocked by veterinary practices in several markets.

Yes - FSSAI approved with a valid Form II, issued under the Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations. The reference is provided in writing with the qualification pack. The nuance worth understanding: approvals under this route are granted to a named applicant, not to the ingredient in general, so a file number held by one company does not cover material bought from a different supplier. Ours is in our own name.

Not as a simple yes-or-no. No EU-wide novel food authorization for PEA has been confirmed. National positions differ, and several member states — Italy most notably — have PEA products on the market under their own frameworks. Treat it as a country-by-country question and take local advice before you commit to a launch.

Regulatory

PEA is marketed there as a dietary-supplement ingredient under DSHEA. At least one supplier holds a self-affirmed GRAS dossier, which is a company determination supported by an expert panel rather than an FDA approval. We have not been able to confirm an FDA-issued GRAS notice or a published new-dietary-ingredient notification for PEA, and we will not claim one exists.

Yes. The TGA permits palmitoylethanolamide as an active in listed medicines, and individual PEA products carry entries on the Australian Register of Therapeutic Goods.

That depends entirely on your market, and it is your responsibility rather than ours. PEA is supplied as a food or nutraceutical ingredient, not as a medicine, and disease claims are not permissible in any of the markets we supply. We will share what other customers have used and give you the underlying literature, but the claim has to be substantiated by the finished-product marketer under local law.

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