This section provides an overview of melatonin powder, covering its manufacturing processes and regulatory status, and applications in food, nutraceutical, and pharmaceutical industries. Also, please check out the introduction to melatonin manufacturers, supply chain issues, melatonin suppliers, and melatonin prices. Sinofi can help you buy melatonin at bulk wholesale prices based on CAS 73-31-4.
Table of Contents
What is Melatonin?
Melatonin is one of the most widely used active ingredients in the global dietary supplement and pharmaceutical markets. In humans, it is synthesized in the pineal gland from serotonin through sequential N-acetylation and O-methylation. Melatonin and gamma-aminobutyric acid are best known to consumers as a sleep aid. But formulation engineers regard it as a technically demanding ingredient whose photosensitivity, low aqueous solubility, and short biological half-life shape nearly every decision in product development. Melatonin contains an indole core substituted with a methoxy group at the 5-position and an N-acetylated ethylamine side chain. Melatonin is sparingly soluble in water (roughly 2 mg/mL at ambient temperature) but dissolves readily in ethanol, methanol, and other polar organic solvents, which influences the design of liquid and sublingual products. In the United States, the FDA regulates melatonin as a dietary supplement rather than a prescription or over-the-counter drug. Because of this classification, melatonin products do not undergo the same pre-market safety, efficacy, and purity testing required for pharmaceutical drugs. It is categorized under the Dietary Supplement Health and Education Act (DSHEA) as a supplement, not a standardized medication.
Physiological Role and Pharmacokinetics
According to the US NIH, its secretion follows a pronounced circadian rhythm, rising in the evening and declining toward morning, and it serves as the body’s principal endocrine signal of darkness. Melatonin acts primarily through the MT1 and MT2 G-protein-coupled receptors, which regulate sleep onset and circadian phase.
Exogenous melatonin exhibits rapid absorption but extensive first-pass hepatic metabolism, principally by CYP1A2, resulting in low and highly variable oral bioavailability, as reported by Mayo Clinic. Its elimination half-life is short, on the order of 40 to 60 minutes for immediate-release forms, according to Shobha George’s research. These pharmacokinetic characteristics explain why the market includes immediate-release products intended to shorten sleep latency alongside extended-release products intended to sustain plasma levels through the night.
Regulatory Status and Safety Considerations
Melatonin has been evaluated by major regulatory bodies like CosIng, CRN, AASM, NIST, EFSA, and EU Health and Food Safety. The regulatory classification of melatonin varies markedly by jurisdiction, a fact that directly affects formulation strategy, labelling, and permissible claims. In the United States, melatonin is marketed as a dietary supplement under the Dietary Supplement Health and Education Act, and products are manufactured under 21 CFR Part 111 current good manufacturing practice requirements. In much of the European Union, the United Kingdom, and Australia, melatonin above certain dose thresholds is regulated as a prescription medicine, and authorized products such as prolonged-release 2 mg tablets exist as licensed pharmaceuticals. In food applications within the European Union, health claims are constrained to specific authorized wording at defined doses. Formulators must therefore confirm the applicable framework in each target market before selecting dose, dosage form, and claim language, and should verify current requirements with the relevant authorities, as these rules continue to evolve.
Melatonin is generally well tolerated at customary doses in adults, with the most commonly reported effects being drowsiness, headache, and vivid dreams. Nevertheless, formulators bear responsibility for risk mitigation through design: child-resistant packaging is strongly advisable, particularly for flavoured gummy formats that have been associated with accidental pediatric ingestions; labels should carry appropriate cautions regarding driving, pregnancy, concomitant medications, and use in children; and dose strengths should be aligned with the evidence base rather than with marketing escalation.
CAS No.: 73-31-4
According to the American Chemical Society, the CAS number of melatonin is 73-31-4.
CAS Name: Melatonin
Molecular Formula: C13H16N2O2
Molecular Mass: 232.28
Appearance: White powder.
Food Chemicals Codex Listed: No
Melting Point: 117.00 °C. @ 760.00 mm Hg
Boiling Point: 512.83 °C. @ 760.00 mm Hg (est)
Solubility: Soluble in water, 1164 mg/L @ 25 °C (est)
Other Names:
♦ Acetamide, N-[2-(5-methoxy-1H-indol-3-yl)ethyl]-
♦ Acetamide, N-[2-(5-methoxyindol-3-yl)ethyl]-
♦ N-[2-(5-Methoxy-1H-indol-3-yl)ethyl]acetamide
♦ N-Acetyl-5-methoxytryptamine
♦ Melatonine
♦ 5-Methoxy-N-acetyltryptamine
♦ Regulin
♦ Melovine
♦ Circadin
♦ Melatol
Bulk Melatonin Manufacturers
The bulk melatonin production has become an increasingly consequential segment for nutraceutical brands, contract manufacturers, and compounding pharmacies. Top melatonin manufacturers like TCI, Merck, Bachem, Rochem, and Spectrum Chemical synthesize melatonin at scale and sell either directly to large international customers or through trading intermediaries. On the demand side, the sleep-health category continues to expand, and melatonin’s migration into functional foods, beverages, and combination formulas with botanicals. Asia-Pacific is widely projected to be the fastest-growing regional market, with China notable both as the dominant producer and as an increasingly significant consumer.
Sinofi is a bulk melatonin manufacturer in China, and we have a manufacturing facility with 2,500 square meters for the production of melatonin. We supply high-quality melatonin at bulk prices and serve food, nutraceutical, and pharmaceutical industries worldwide.
Manufacturing Process of Melatonin
The melatonin production is a mature area of process chemistry in which the intellectual challenge lies not in bond construction but in delivering a colourless, oxidatively stable, low-impurity crystalline solid at commodity cost. Three broad approaches exist in principle, of which only one is currently dominant.
Extraction from Natural Sources
Melatonin occurs in animal pineal tissue and in a variety of plants at concentrations in the nanogram-to-microgram per gram range. The extraction economics are prohibitive, and animal-derived material carries an unacceptable adventitious agent risk.
Fermentation and Biocatalysis
Engineered Escherichia coli and Saccharomyces cerevisiae strains expressing the four-enzyme mammalian pathway — tryptophan hydroxylase, aromatic L-amino acid decarboxylase, serotonin N-acetyltransferase, and acetylserotonin O-methyltransferase — have been shown to convert tryptophan or glucose to melatonin.
Principal Synthetic Routes
All practical chemical syntheses converge on one of two strategic decisions: either the 5-methoxyindole nucleus is purchased or prepared first and then elaborated at the 3-position, or the indole ring is constructed by cyclization of an acyclic precursor that already carries the acetamidoethyl side chain.
Preparation of the 5-Methoxyindole Nucleus
Where the linear strategy is adopted, 5-methoxyindole is the pivotal raw material and typically the dominant cost driver. Industrially, it is most commonly prepared by the Leimgruber–Batcho protocol from 4-methoxy-2-nitrotoluene. Condensation of the activated methyl group with N,N-dimethylformamide dimethyl acetal, generally in the presence of pyrrolidine, affords the corresponding enamine, which is then subjected to reductive cyclization. The reduction step may be effected by catalytic hydrogenation over palladium on carbon or Raney nickel, or by dissolving-metal or dithionite-based systems. The Leimgruber–Batcho sequence is well suited to scale because it avoids strongly acidic conditions that would otherwise threaten the methyl aryl ether.
The Speeter–Anthony Route
The classical laboratory approach proceeds by Friedel–Crafts-type acylation of 5-methoxyindole at C-3 with oxalyl chloride to give the indol-3-ylglyoxylyl chloride, which is quenched with ammonia or with methanolic ammonia to furnish the glyoxylamide. Exhaustive reduction of the resulting α-keto amide with lithium aluminum hydride or a borane reagent delivers 5-methoxytryptamine, which is then acetylated.
Bulk Melatonin Suppliers
The bulk melatonin supply can be understood in some tiers, each serving a distinct buyer profile. Top melatonin suppliers like TCI, Merck, Bachem, Rochem, and Spectrum Chemical operate GMP-certified plants, maintain drug master files or comparable regulatory documentation, and sell in commercial volumes directly to large formulators and distributors.
Sinofi is a bulk melatonin supplier in China, and we have a warehouse with 1,200 square meters for high-quality melatonin. We sell different grades of melatonin at wholesale prices, serving end-users in food, nutraceutical, and pharmaceutical industries.
Supply Chain of Melatonin
The melatonin supply chain of the late 2020s is likely to look different from that of the early 2020s in three respects. Upstream, fermentation-derived and bio-based melatonin should gain share as costs fall and as brands seek “clean-label” narratives with verifiable traceability. Midstream, quality certification and batch-level transparency will shift from differentiators to entry requirements, favouring GMP-audited producers with robust documentation. Downstream, growth will tilt toward medically positioned, extended-release, and combination products distributed through pharmacy and e-commerce channels, while regulators in major markets move toward stricter dosage and labelling standards. Participants who invest early in supply diversification, independent verification, and regulatory intelligence will be best positioned to capture the category’s continued growth while insulating themselves from its most predictable disruptions.
Wholesale and Buy Melatonin in Bulk
Successful bulk procurement of melatonin requires more than negotiating a low unit price. It requires disciplined supplier qualification, careful attention to quality documentation, and a clear-eyed view of regulatory and logistical realities.
Understanding the Product and Its Formats
Melatonin is available to commercial buyers in several forms, and the right choice depends entirely on the intended use. Manufacturers producing their own finished goods typically purchase bulk melatonin powder, most commonly at 99 percent purity or higher, packed in 25-kilogram drums or smaller foil-lined containers. Brands pursuing private-label programs, by contrast, often buy finished formats such as tablets, capsules, gummies, liquid drops, or fast-dissolving strips, either in bulk bins for in-house packaging or fully labelled and retail-ready. Common finished-product strengths range from 1 milligram to 10 milligrams per serving, and combination formulas pairing melatonin with ingredients such as L-theanine, magnesium, or botanical extracts have become increasingly popular. A purchasing manager should confirm early in the sourcing conversation which format, strength, and formulation the business actually needs, because pricing, minimum order quantities, and lead times differ substantially across these categories.
Qualifying Suppliers
Supplier qualification is the foundation of any successful bulk melatonin program. The global supply of synthetic melatonin is concentrated among a relatively small number of large ingredient manufacturers, with many distributors and traders operating between those producers and end buyers. Third-party testing is a further safeguard. Independent analyses published in recent years have documented significant discrepancies between labelled and actual melatonin content in some finished products, so verification through an accredited laboratory protects both the business and the end consumer.
Pricing, Minimums, and Negotiation
Bulk melatonin powder is, in raw material terms, relatively inexpensive, and pricing improves meaningfully at volume breakpoints. Finished goods carry additional costs for excipients, manufacturing, packaging, and labelling. Minimum order quantities vary widely: ingredient suppliers may set minimums of a single 25-kilogram drum, while contract manufacturers of gummies or tablets often require production runs in the tens of thousands of units.
As a bulk melatonin manufacturer and supplier in China, we wholesale this ingredient to end users in food, nutraceutical, and pharmaceutical industries. We also supply melatonin to small customers. Normally, they want to buy melatonin in small quantities. To serve them, we can sell melatonin at bulk prices and provide a one-stop purchasing service.
Melatonin Prices (USD/Kg)
Food Grade Melatonin Prices (USP/EP, HPLC Content >=99.0%)
| Volume | Unit Price | Shipment |
| 50g | 20 USD | Express |
| 500g | 98 USD | Express |
| 1Kg | 135 USD/Kg | Express |
| 25Kg | 108 USD/Kg | Express |
| 100Kg | >=30% cheaper | Express / Sea |
| 200Kg-Above | negotiable | Express / Sea |
Melatonin bulk pricing spans a wide band determined chiefly by purity and source. Chinese manufacturers advertise bulk melatonin powder at roughly USD 90-150/kg. The wide price gap reflects grade (pharmaceutical/USP-EP versus food/supplement grade), order size, and purity documentation. Plant-derived and biotechnical melatonin commands a substantial premium, roughly 2-3x that of synthetic.
Furthermore, the above melatonin price quotations do not include the express fee. The reason is that the shipment cost may exceed the sample value of melatonin. However, the bulk wholesale prices of melatonin will be much lower than those of small orders. Please contact us for more details.
Melatonin Specification
| Appearance | Off-white powder |
| Purity (HPLC, on dry basis) | >=99% |
| Moisture (%) | <=0.5 |
| Ash (%) | <=0.5 |
| Total Impurities (%) | <=0.5 |
| Burning Residue (%) | <=0.1 |
| Chloride (%) | <=0.02 |
| Emodin (%) | Not detected |
| Residual Solvents (Ethanol, ppm) | <=1000 |
| Heavy Metals (ppm) | <=10 |
| Pb (ppm) | <=2.0 |
| Cd (ppm) | <=1.0 |
| As (ppm) | <=1.0 |
| Hg (ppm) | <=0.1 |
Melatonin Uses
Melatonin is a valuable and generally safe aid for problems rooted in circadian timing, including jet lag, delayed sleep phase, and, to a lesser extent, shift work adaptation. Its benefits for ordinary insomnia are real but modest, and it is not a substitute for good sleep habits or for evidence-based treatments such as cognitive behavioural therapy.
How Melatonin Works
Unlike conventional sedatives, melatonin does not force the body into sleep. Rather, it acts as a chronobiotic, meaning that it shifts and reinforces the timing of the body’s internal clock. Supplemental melatonin binds to receptors in the brain, primarily the MT1 and MT2 receptors, which reduce alertness and help synchronize circadian timing. This distinction is important for understanding both its strengths and its limitations: melatonin is generally most effective for problems related to the timing of sleep rather than the ability to sleep itself.
Jet Lag
Jet lag remains one of the best-supported uses of melatonin. When travellers cross multiple time zones, the internal clock becomes misaligned with the local day–night cycle, producing fatigue, insomnia, and impaired concentration. Clinical studies have consistently shown that melatonin, taken close to the target bedtime at the destination, can reduce the severity and duration of jet lag symptoms, particularly for eastward travel across five or more time zones.
Delayed Sleep–Wake Phase Disorder
Individuals with delayed sleep–wake phase disorder have an internal clock that runs significantly later than conventional schedules, making it difficult to fall asleep before the early morning hours and to wake at socially expected times. Low doses of melatonin administered several hours before the desired bedtime, often combined with carefully timed morning light exposure, can gradually shift the sleep schedule earlier. This condition is especially common among adolescents and young adults, and melatonin is considered a first-line intervention when administered under clinical guidance.
General Insomnia
Melatonin is commonly used for ordinary difficulty falling asleep. The evidence here is more modest than many consumers assume. Meta-analyses suggest that melatonin reduces the time required to fall asleep by a relatively small margin, typically on the order of several minutes, and produces slight improvements in total sleep time. It tends to be more helpful for individuals whose insomnia stems from circadian misalignment than for those whose insomnia is driven by anxiety, pain, or other underlying conditions. For chronic insomnia, cognitive behavioural therapy for insomnia remains the recommended first-line treatment.
Sleep Difficulties in Children with Neurodevelopmental Conditions
Melatonin has been studied in children with autism spectrum disorder and attention-deficit/hyperactivity disorder, populations in which sleep-onset difficulties are common. Research indicates that melatonin can meaningfully shorten the time these children take to fall asleep. Use in pediatric populations should always occur under the supervision of a physician, as long-term effects in children have not been fully characterized.
Dosage and Timing Considerations
One of the most common misconceptions about melatonin is that higher doses produce better results. In practice, doses in the range of 0.5 to 3 milligrams are often sufficient, and research suggests that lower doses can be as effective as higher ones while producing fewer side effects such as grogginess. Timing is equally important: for circadian applications, melatonin is typically taken thirty minutes to several hours before the intended bedtime, depending on the goal.
Melatonin Benefits
Melatonin is best understood as a timing signal rather than a sleeping pill. Its clearest benefits lie in realigning the body’s internal clock, whether disrupted by transmeridian travel, a delayed sleep phase, blindness-related rhythm disorders, or shift work, and it offers a modest, low-risk boost for people who simply take too long to fall asleep.
Supporting the Body’s Internal Clock
Melatonin’s best-documented role is not as a sedative but as a chronobiotic, meaning a substance that helps shift the timing of the body’s circadian rhythm. The brain’s master clock, located in the suprachiasmatic nucleus, relies on melatonin as one of its principal timing cues. When taken at the right time of day, supplemental melatonin can nudge that clock earlier or later, which explains why it performs best in conditions where the internal clock is misaligned with the external world rather than in ordinary insomnia.
Antioxidant and Emerging Areas of Research
Beyond sleep, melatonin is a potent antioxidant and free-radical scavenger, and laboratory research has explored its potential roles in immune modulation, eye health, and cellular protection. Some clinical studies have examined perioperative anxiety, migraine prevention, and gastrointestinal conditions with encouraging preliminary results. These areas remain investigational, however, and the evidence is not yet strong enough to support routine use for purposes other than sleep and circadian timing.
A Herbal Composition Using Melatonin for Improving Sleep Quality
Include the following ingredients (by weight):
Processed Polygonatum extract, 30 parts; stir-fried Ziziphus jujuba seed extract, 20 parts; Lilium brownii extract, 15 parts; gamma-aminobutyric acid, 5 parts; melatonin, 1 part; and pharmaceutically or food-grade excipients.
The processed Polygonatum extract is obtained by water extraction and alcohol precipitation of Polygonatum sibiricum processed by a nine-steaming and nine-drying process, wherein the content of Polygonatum sibiricum polysaccharides is not less than 50%; the stir-fried Ziziphus jujuba seed extract is obtained by supercritical CO2 extraction of Ziziphus jujuba seeds after gentle stir-frying, wherein the total content of spinosin and jujuboside A is not less than 3%; the Lilium brownii extract is obtained by microwave-assisted eutectic solvent extraction from Lilium brownii bulbs, wherein the total content of Lilium brownii polysaccharides and Lilium brownii saponins is not less than 40%.
In conclusion, melatonin has evolved from a niche sleep aid into one of the most commercially significant ingredients in the global nutraceutical industry. As a bulk melatonin manufacturer and supplier in China, we sell different grades of melatonin at wholesale prices to clients around the world.