Active Pharmaceutical Ingredient

Acetaminophen API Manufacturer & Supplier in India

Also known as: Paracetamol

CAS: 103-90-2 Analgesic / Antipyretic USP / BP / IP Bulk Supply Available
Acetone

Product Overview

CAS No: 103-90-2  |  MF: C₈H₉NO₂  |  MW: 151.16 g/mol

Acetaminophen (Paracetamol) is one of the most widely used analgesic and antipyretic agents worldwide. It is effective in reducing fever and relieving mild to moderate pain with an excellent safety profile when used at recommended doses. Mediocon Inc supplies pharmaceutical-grade Acetaminophen meeting USP, BP, and IP standards for bulk pharma and OTC formulations.

Key Features

  • Widely accepted analgesic & antipyretic
  • USP/BP/IP compliant quality
  • Low gastric irritation profile
  • Suitable for pediatric & adult formulations

Applications

  • Fever management tablets & syrups
  • OTC pain relief products
  • Combination analgesic formulations
  • Pediatric suspensions

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 NameAcetaminophen
Also Known AsParacetamol
CAS Number103-90-2
Molecular FormulaC₈H₉NO₂
Molecular Weight151.16 g/mol
CategoryAnalgesic / Antipyretic
AppearanceWhite Crystalline Powder
GradeUSP / BP / IP

Analytical Specifications

ParameterSpecification
Assay98.0% – 101.0%
Loss on DryingNMT 0.5%
Melting Point168°C – 172°C
Heavy MetalsNMT 10 ppm
pH5.5 – 6.5 (1% solution)
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 Acetaminophen (CAS 103-90-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Acetaminophen 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 — Acetaminophen API

What is the minimum order quantity for Acetaminophen API?
Mediocon Inc supplies Acetaminophen 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 Acetaminophen does Mediocon supply?
We supply Acetaminophen conforming to USP / BP / IP 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 Acetaminophen API?
Every shipment of Acetaminophen 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 Acetaminophen bulk orders?
Standard lead time for Acetaminophen 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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