Dupilumab API Manufacturer India

High-Purity Anti-IL-4Rα Monoclonal Antibody Biologic for Atopic Dermatitis and Asthma Formulations

Quick Answer: Dupilumab API (CAS 1190264-60-8) is a Monoclonal Antibody Biologic manufactured and supplied in bulk by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified facility in Maharashtra, India. It is available in Biologic / Injectable Grade grades with full CoA, MSDS, and DMF documentation, MOQ from 1 kg (sample) to 25 kg+ (commercial), standard lead time 2–4 weeks, and export support to 40+ countries.

Reviewed by Swapnroop Quality Assurance Team · Last updated
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Dupilumab API Manufacturer India

Product Specifications

Product Name: Dupilumab API
CAS Number: 1190264-60-8
Category: Monoclonal Antibody Biologic
Grade: Biologic / Injectable Grade
Appearance: Clear to slightly opalescent, colourless to pale yellow solution
Standards: Biologic / Injectable Grade compliant

Detailed Specifications

ParameterSpecification
AppearanceClear to slightly opalescent, colourless to pale yellow solution
IdentificationPeptide Map / HPLC compliant
Purity (SE-HPLC)≥98.0%
Protein ContentAs per label claim ± 10%
EndotoxinNMT 0.5 EU/mg
BioburdenWithin compendial limits
pHAs per product specification
Host Cell ProteinWithin qualified limits
Aggregates/FragmentsWithin compendial limits

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

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What is Dupilumab API? (CAS No: 1190264-60-8)

High-Purity Anti-IL-4Rα Monoclonal Antibody Biologic for Atopic Dermatitis and Asthma Formulations

Dupilumab API is a Monoclonal Antibody Biologic sold in bulk as an Active Pharmaceutical Ingredient (API), positioned for companies seeking a dependable ingredient source backed by organized quality systems and scalable supply support.

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

Dupilumab 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 monoclonal antibody-based immunology biologic formulations.

How to Order Dupilumab API

  1. Send an enquiry via WhatsApp, email, or phone with your required quantity and grade.
  2. Receive product specifications, a CoA sample, and a formal bulk quote from our team.
  3. Confirm order terms, request samples if needed, and finalize documentation (MSDS, DMF, regulatory dossier).
  4. Receive scheduled dispatch with export documentation for domestic or international delivery.

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 Dupilumab in pharma-oriented cold-chain packaging formats including single-use vials with validated insulated shippers and temperature monitoring, helping maintain product integrity during storage, shipping, and routine cold-chain supply movement.

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Frequently Asked Questions about Dupilumab API

What is Dupilumab API used for?

Dupilumab API is a Monoclonal Antibody Biologic supplied in bulk to licensed pharmaceutical manufacturers, who use it as the active ingredient to formulate finished dosage forms, subject to regulatory approval in the destination market.

What is the CAS number for Dupilumab API?

The CAS number for Dupilumab API is 1190264-60-8. It is an Active Pharmaceutical Ingredient (API) manufactured by Swapnroop Drugs and Pharmaceuticals, a WHO-GMP certified company in Maharashtra, India.

What pharmacopeial grades is Dupilumab API available in?

Dupilumab API is available in Biologic / Injectable Grade pharmacopeial grades with HPLC purity ≥98.0%. All batches come with full CoA, MSDS, and pharmacopeial identification testing.

What is the MOQ and lead time for Dupilumab 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 Dupilumab API?

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

Does Swapnroop export Dupilumab API internationally?

Yes, Swapnroop exports Dupilumab 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.

Dupilumab API Bulk Supplier in India

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

Dupilumab API Manufacturer for Commercial Sourcing

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