Active Pharmaceutical Ingredient

Melatonin API Manufacturer & Supplier in India

Also known as: N-Acetyl-5-methoxytryptamine

CAS: 73-31-4 Sleep Aid / Circadian Rhythm Regulator IP / BP / USP GMP Certified Aurangabad, Maharashtra, India
Melatonin API — Mediocon Inc
Melatonin — Pharmaceutical Grade API

Product Overview

CAS No: 73-31-4  |  MF: C₁₃H₁₆N₂O₂  |  MW: 232.28 g/mol

Melatonin is a pharmaceutical-grade active ingredient classified as Sleep Aid / Circadian Rhythm Regulator. Mediocon Inc supplies high-purity Melatonin API conforming to IP / BP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Natural sleep hormone analogue
  • IP/BP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Insomnia and sleep disorders
  • Jet lag management
  • Circadian rhythm disorders
  • Melatonin supplement formulations

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameMelatonin
Also Known AsN-Acetyl-5-methoxytryptamine
CAS Number73-31-4
Chemical NameN-acetyl-5-methoxytryptamine
Molecular FormulaC₁₃H₁₆N₂O₂
Molecular Weight232.28 g/mol
CategorySleep Aid / Circadian Rhythm Regulator
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in ethanol; sparingly soluble in water
GradeIP / BP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Melatonin (CAS 73-31-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Melatonin is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Melatonin API

What is the minimum order quantity for Melatonin API?
Mediocon Inc supplies Melatonin with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Melatonin does Mediocon supply?
We supply Melatonin conforming to IP / BP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Melatonin API?
Every shipment of Melatonin comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Melatonin bulk orders?
Standard lead time for Melatonin is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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