Apixaban API Manufacturer in Maharashtra, India

Anticoagulant – Manufacturer and Bulk Supplier in Maharashtra for Thrombosis Prevention And Anticoagulation Formulations

Apixaban API Manufacturer and Bulk Supplier in Maharashtra, India – Swapnroop Pharma

Product Specifications

Product Name: Apixaban API
CAS Number: 503612-47-3
Category: Active Pharmaceutical Ingredient
Grade: Apixaban 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%

Apixaban API (CAS No: 503612-47-3)

WHO-GMP Certified Apixaban API Manufacturer in Maharashtra, India

Apixaban API (CAS 503612-47-3) is an Active Pharmaceutical Ingredient used in the formulation of prescription and/or over-the-counter pharmaceutical products. Swapnroop Drugs and Pharmaceuticals manufactures and supplies Apixaban API with pharmacopeial compliance (IP/BP/EP/USP as applicable) from our WHO-GMP certified facility in Aurangabad (MIDC Shendra), Maharashtra — one of India's premier pharmaceutical manufacturing zones with robust regulatory infrastructure.

Pharmaceutical formulation companies sourcing Apixaban API require consistent polymorphic or salt form characterisation, batch-to-batch HPLC purity ≥98% (or per specific pharmacopeial monograph), validated residual solvent control per ICH Q3C, and full impurity profiling against pharmacopeial limits. Our quality control laboratory performs complete pharmacopeial testing with USP/EP/IP validated analytical methods before every batch release.

Swapnroop's Apixaban API supply is backed by WHO-GMP certified manufacturing, a qualified vendor documentation package (CoA, MSDS, Certificate of Origin, stability data), and dedicated technical support for domestic formulation companies and international export customers. We maintain inventory for rapid order fulfilment across 25+ countries served from our Aurangabad facility.

Key Features

  • HPLC purity ≥98.0% (or per specific IP/BP/USP monograph for Apixaban)
  • Complete pharmacopeial testing: identification, assay, impurities, LOD, residue on ignition
  • Residual solvent control per ICH Q3C with validated GC/headspace methodology
  • WHO-GMP certified batch with full documentation package for regulatory submissions

Applications

  • Pharmaceutical tablet and capsule formulation development using Apixaban API
  • Injectable or parenteral formulation programs where Apixaban is indicated
  • R&D, pilot batch, and commercial manufacturing for domestic and regulated markets
  • Fixed-dose combination (FDC) drug product development programs

Why Choose Swapnroop for Apixaban?

  • WHO-GMP certified Aurangabad facility with CDSCO-approved manufacturing unit
  • Complete qualified vendor documentation: CoA, MSDS, CoO, stability reports
  • Export capability to 25+ countries with pharmacopeial-grade API
  • Responsive technical support and dedicated account management for long-term buyers

Packaging & Supply

Apixaban API is supplied in double-polyethylene-lined HDPE drums or fiber drums (25 kg net) with desiccant and nitrogen head-space. Smaller quantities (1 kg, 5 kg) in sealed HDPE jars for R&D programs. All packaging labelled with batch, grade, and pharmacopeial standard.

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Frequently Asked Questions about Apixaban API

What is the CAS number for Apixaban API?

The CAS number for Apixaban is 503612-47-3. It is a Anticoagulant used in pharmaceutical thrombosis prevention and anticoagulation formulations.

What therapeutic class does Apixaban belong to?

Apixaban is classified as a Anticoagulant. It is used in thrombosis prevention and anticoagulation formulations and is an established API in both domestic Indian and international pharmaceutical markets.

What grades and purity specifications are available for Apixaban API?

Apixaban 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 Apixaban 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 Apixaban API?

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

Apixaban API Bulk Supplier in Aurangabad, Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Apixaban 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 Apixaban API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.

Apixaban API Exporter from India – Regulatory Filing Support

As a Apixaban 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 Apixaban API pricing, samples, and sourcing support.