Active Pharmaceutical Ingredient

Acetylsalicylic acid API Manufacturer & Supplier in India

Also known as: Aspirin

CAS: 50-78-2 Analgesic / NSAID USP / BP / IP Bulk Supply Available
Acetylsalicylic acid API Manufacturer India | Mediocon Inc
Acetylsalicylic acid — Pharmaceutical Grade API

Product Overview

CAS No: 50-78-2  |  MF: C₉H₈O₄  |  MW: 180.16 g/mol

Acetylsalicylic acid (Aspirin) is one of the oldest and most widely used analgesic, antipyretic, and anti-inflammatory agents. It belongs to the class of NSAIDs and is also used in low doses as a cardioprotective agent. Mediocon Inc supplies pharmaceutical-grade Acetylsalicylic acid meeting USP, BP, and IP standards for bulk pharma manufacturing.

Key Features

  • Analgesic, antipyretic & anti-inflammatory
  • USP/BP/IP compliant quality
  • Widely used in cardiovascular therapy
  • Suitable for tablet and effervescent formulations

Applications

  • Pain relief and fever tablets
  • Cardio-protective low-dose tablets
  • Anti-inflammatory formulations
  • Effervescent and chewable tablets

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 NameAcetylsalicylic acid
Also Known AsAspirin
CAS Number50-78-2
Molecular FormulaC₉H₈O₄
Molecular Weight180.16 g/mol
CategoryAnalgesic / Anti-inflammatory / Antipyretic
AppearanceWhite Crystalline Powder
GradeUSP / BP / IP

Analytical Specifications

ParameterSpecification
Assay99.5% – 100.5%
Loss on DryingNMT 0.5%
Melting Point135°C – 138°C
Heavy MetalsNMT 10 ppm
pHN/A
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 Acetylsalicylic acid (CAS 50-78-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Acetylsalicylic acid 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 — Acetylsalicylic acid API

What is the minimum order quantity for Acetylsalicylic acid API?
Mediocon Inc supplies Acetylsalicylic acid 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 Acetylsalicylic acid does Mediocon supply?
We supply Acetylsalicylic acid 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 Acetylsalicylic acid API?
Every shipment of Acetylsalicylic acid 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 Acetylsalicylic acid bulk orders?
Standard lead time for Acetylsalicylic acid 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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