Ursodeoxycholic Acid API Manufacturer India

High-Quality Active Pharmaceutical Ingredient for Active Pharmaceutical Ingredient Formulations

Swapnroop Pharma  ·  WHO-GMP Certified  ·  +91 87670 62101
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Ursodeoxycholic Acid API Manufacturer India

Product Specifications

Product Name: Ursodeoxycholic Acid API
CAS Number: 128-13-2
Category: Active Pharmaceutical Ingredient
Grade: IP / BP / EP / USP
Appearance: White to off-white crystalline powder
Standards: IP / BP / EP / USP compliant

Detailed Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder
IdentificationIR & HPLC compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)2.0 – 4.0
Individual Impurity≤ 0.5%
Total Impurities≤ 1.5%

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WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries

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Ursodeoxycholic Acid API (CAS No: 128-13-2)

High-Quality Active Pharmaceutical Ingredient for Active Pharmaceutical Ingredient Formulations

Our Ursodeoxycholic Acid supply program is built around repeatable batch quality, responsive communication, and practical support for formulation teams and procurement teams alike.

Our manufacturing and supply approach for Ursodeoxycholic Acid emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.

Before approving a new source, most formulation teams review Ursodeoxycholic Acid for assay consistency, impurity profile, and the completeness of supporting documentation — all of which we prioritise.

Key Features

  • Supply planning suited to domestic and export demand
  • Dedicated technical support for specification queries
  • Traceable batch records maintained for every dispatch
  • Flexible order quantities from sampling to commercial scale

Applications

  • Applicable for R&D evaluation ahead of larger-scale sourcing decisions
  • Fits into both domestic manufacturing and export-oriented supply chains
  • Useful for buyers building a secondary or backup supplier base
  • Suitable for regulatory filing support where DMF-grade documentation is required

Why Choose Us

  • Dedicated point of contact for order and documentation follow-up
  • Track record of supporting export shipments across multiple regions
  • Transparent batch numbering and record-keeping for easy audits
  • Consistent commercial communication and responsive quotation support

Packaging & Supply

We offer Ursodeoxycholic Acid in pharma-oriented packaging formats including HDPE or fiber drum options with inner protection layers, helping maintain handling quality during storage, shipping, and routine supply movement.

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Frequently Asked Questions about Ursodeoxycholic Acid API

What is the CAS number for Ursodeoxycholic Acid API?

The CAS number for Ursodeoxycholic Acid API is 128-13-2. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.

What pharmacopeial grades is Ursodeoxycholic Acid API available in?

Ursodeoxycholic Acid API is available in IP, BP, EP, and USP pharmacopeial grades with quality testing per pharmacopoeial and in-house specifications. All batches come with full CoA and MSDS.

What is the MOQ and lead time for Ursodeoxycholic Acid API?

Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply is available for larger volumes.

Is DMF documentation available for Ursodeoxycholic Acid API?

Yes, Swapnroop provides full DMF-grade documentation for Ursodeoxycholic Acid API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.

Does Swapnroop export Ursodeoxycholic Acid API internationally?

Yes, Swapnroop exports Ursodeoxycholic Acid API to 40+ countries including the USA, UK, UAE, Germany, Australia, South Africa, Nigeria, Kenya, Brazil, and Southeast Asian markets. We provide full export documentation and regulatory support.

Ursodeoxycholic Acid API Bulk Supplier in India

For companies evaluating Ursodeoxycholic Acid API manufacturer options in India, this page offers a clear overview of the product profile, quality approach, and supply readiness.

Ursodeoxycholic Acid API Manufacturer for Commercial Sourcing

Our team works with buyers who need Ursodeoxycholic Acid API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.