Sitagliptin Phosphate API Manufacturer India

High-Quality Active Pharmaceutical Ingredient for Antidiabetic Formulations

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

Product Specifications

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

High-Quality Active Pharmaceutical Ingredient for Antidiabetic Formulations

Sitagliptin Phosphate API is positioned for companies seeking a dependable active pharmaceutical ingredient source backed by organized quality systems and scalable supply support.

We work closely with customers on Sitagliptin Phosphate to align batch documentation, packaging preferences, and delivery schedules with their internal qualification timelines.

Procurement teams typically evaluate Sitagliptin Phosphate suppliers on regulatory documentation, packaging integrity, and reliability of repeat supply, which shapes how we manage this product line.

Key Features

  • Dedicated technical support for specification queries
  • Traceable batch records maintained for every dispatch
  • Flexible order quantities from sampling to commercial scale
  • Quality checks aligned with pharmacopoeial requirements

Applications

  • 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
  • Suitable for formulation development and scale-up studies

Why Choose Us

  • 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
  • Focus on repeatability, supply continuity, and practical business support

Packaging & Supply

Sitagliptin Phosphate is packed in HDPE drums or fiber drums with double poly-lined inner bags, chosen to protect product integrity through transit, warehousing, and routine handling.

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Frequently Asked Questions about Sitagliptin Phosphate API

What is the CAS number for Sitagliptin Phosphate API?

The CAS number for Sitagliptin Phosphate 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 Phosphate API available in?

Sitagliptin Phosphate 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 Phosphate 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 Phosphate API?

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

Does Swapnroop export Sitagliptin Phosphate API internationally?

Yes, Swapnroop exports Sitagliptin Phosphate 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 Phosphate API Bulk Supplier in India

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

Sitagliptin Phosphate API Manufacturer for Commercial Sourcing

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