Active Pharmaceutical Ingredient

Hyaluronic Acid (CAS 9004-61-9) API Manufacturer & Supplier in India

Also known as: Hyaluronan / HA / Sodium Hyaluronate

CAS: 9004-61-9 Glycosaminoglycan / Biopolymer IP / BP / EP / USP Bulk Supply Available
Hyaluronic Acid API Manufacturer India | Mediocon Inc
Hyaluronic Acid — Pharmaceutical Grade API

Product Overview

CAS No: 9004-61-9  |  MF: (C₁₄H₂₁NO₁₁)ₙ  |  MW: Variable (5 kDa – 2 MDa)

Hyaluronic Acid (Hyaluronan) is a naturally occurring glycosaminoglycan found in connective tissue, synovial fluid, and skin. It is widely used in ophthalmic, orthopedic, and dermatological applications. Mediocon Inc supplies multiple molecular weight grades meeting IP/BP/EP/USP standards.

Key Features

  • Multiple MW grades available (LMW, MMW, HMW)
  • IP/BP/EP/USP compliant
  • High viscoelasticity and biocompatibility
  • Suitable for injectable and topical use

Applications

  • Ophthalmic viscosurgical devices (OVD)
  • Intra-articular injections for osteoarthritis
  • Dermal fillers and aesthetic medicine
  • Wound healing and tissue engineering

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 NameHyaluronic Acid
Also Known AsHyaluronan / HA / Sodium Hyaluronate
CAS Number9004-61-9
Molecular Formula(C₁₄H₂₁NO₁₁)ₙ
Molecular WeightVariable (5 kDa – 2 MDa)
CategoryGlycosaminoglycan / Biopolymer
AppearanceWhite to Off-white Powder or Fibrous Material
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay95.0% – 105.0%
Loss on DryingNMT 10.0%
Heavy MetalsNMT 20 ppm
pH6.0 – 7.5 (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 Hyaluronic Acid (CAS 9004-61-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Hyaluronic 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 — Hyaluronic Acid API

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