Sitagliptin Hydrochloride API Manufacturer India

High-Quality Active Pharmaceutical Ingredient for Antidiabetic Formulations

Swapnroop Pharma  ·  WHO-GMP Certified  ·  +91 87670 62101
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Sitagliptin Hydrochloride API Manufacturer India

Product Specifications

Product Name: Sitagliptin Hydrochloride API
CAS Number: Available on Request
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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Sitagliptin Hydrochloride API (CAS No: Available on Request)

High-Quality Active Pharmaceutical Ingredient for Antidiabetic Formulations

Our Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride emphasizes dependable commercial support, efficient order management, and pharma-focused service for long-term buyers.

Before approving a new source, most formulation teams review Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride API

What is the CAS number for Sitagliptin Hydrochloride API?

The CAS number for Sitagliptin Hydrochloride API is Available on Request. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.

What pharmacopeial grades is Sitagliptin Hydrochloride API available in?

Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride 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 Sitagliptin Hydrochloride API?

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

Does Swapnroop export Sitagliptin Hydrochloride API internationally?

Yes, Swapnroop exports Sitagliptin Hydrochloride 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.

Sitagliptin Hydrochloride API Bulk Supplier in India

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

Sitagliptin Hydrochloride API Manufacturer for Commercial Sourcing

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