Metformin API Manufacturer India

Biguanide – Manufacturer and Bulk Supplier in Maharashtra for Type 2 Diabetes Management Tablet Formulations

Metformin API Manufacturer India

Product Specifications

Product Name: Metformin API
CAS Number: Available-On-Request
Category: Active Pharmaceutical Ingredient
Grade: Metformin 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%

Metformin API (CAS No: Available-On-Request)

High-Quality Active Pharmaceutical Ingredient for Anti-Infective and Antiviral Formulations

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

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

Metformin is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.

Key Features

  • Documentation support aligned with customer qualification needs
  • Batch-to-batch consistency focused for commercial supply
  • Bulk packaging options designed for safe storage and dispatch
  • Supply planning suited to domestic and export demand

Applications

  • Suitable for formulation development and scale-up studies
  • Used by pharmaceutical buyers seeking consistent raw material supply and documentation coordination
  • Can support commercial procurement, validation batches, and routine production programs
  • Supports manufacturers working on anti-infective, antiviral, and infection-management dosage forms.

Why Choose Us

  • Consistent commercial communication and responsive quotation support
  • Focus on repeatability, supply continuity, and practical business support
  • Bulk packaging and logistics support for domestic and export dispatch
  • Structured documentation assistance for buyer evaluation

Packaging & Supply

We offer Metformin API 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 Metformin Hydrochloride API

What is the CAS number for Metformin Hydrochloride API?

The CAS number for Metformin Hydrochloride is Available-On-Request. It is a Biguanide used in pharmaceutical Type 2 diabetes management tablet formulations.

What therapeutic class does Metformin Hydrochloride belong to?

Metformin Hydrochloride is classified as a Biguanide. It is used in Type 2 diabetes management tablet formulations and is an established API in both domestic Indian and international pharmaceutical markets.

What grades and purity specifications are available for Metformin Hydrochloride API?

Metformin Hydrochloride API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%, complete related substances profiling, and residual solvent analysis per ICH Q3C guidelines.

What is the minimum order quantity and lead time for Metformin 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. Larger volumes may be available from existing stock.

Is DMF-grade documentation available for Metformin Hydrochloride API?

Yes, Swapnroop provides complete DMF-grade documentation for Metformin Hydrochloride API including Certificate of Analysis (CoA), MSDS, impurity profile, residual solvent certificate, and regulatory filing support for USFDA, EMA, and CDSCO submissions.

Metformin Hydrochloride API Bulk Supplier in Aurangabad, Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Metformin Hydrochloride API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Metformin Hydrochloride API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.

Metformin Hydrochloride API Exporter from India – Regulatory Filing Support

As a Metformin Hydrochloride API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Metformin Hydrochloride API pricing, samples, and sourcing support.