Alemtuzumab API Supplier in Maharashtra, India

WHO-GMP Certified Biological / Recombinant Protein API Supplier

Alemtuzumab API Supplier Maharashtra India

Product Specifications

Product Name: Alemtuzumab
CAS Number: 216503-57-9
Category: Biological / Recombinant Protein API
Grade: Alemtuzumab In-house validated specifications
Appearance: White to off-white lyophilized powder / sterile solution
Standards: In-house validated specifications (Ph. Eur. bioassay / ELISA)

Detailed Specifications

ParameterSpecification
AppearanceWhite to off-white lyophilized powder / sterile solution
IdentificationSDS-PAGE / Western Blot / Peptide Mapping
Purity (SEC-HPLC)≥ 98.0%
Protein ContentAs per validated assay (Lowry / UV280)
Potency (Bioassay)80% – 125% of label claim
Endotoxin< 1.0 EU/mg
BioburdenNMT 10 CFU/g
Moisture ContentNMT 2.0% (lyophilized form)

Alemtuzumab API (CAS No: 216503-57-9)

WHO-GMP Certified Biological / Recombinant Protein API Supplier

Alemtuzumab (CAS 216503-57-9) is a biological active ingredient classified as a anti-cd52 monoclonal antibody, used in the treatment of B-cell chronic lymphocytic leukemia and relapsing multiple sclerosis. As a trusted Alemtuzumab sourcing partner in India, Swapnroop Drugs & Pharmaceuticals connects pharmaceutical formulators and research organizations to consistent supply with complete batch documentation for regulated and semi-regulated markets.

Organizations sourcing Alemtuzumab evaluate SEC-HPLC purity (≥98.0%), confirmed identity by SDS-PAGE / Western blot / peptide mapping, validated potency by bioassay, and tightly controlled endotoxin and bioburden limits. Cold-chain integrity and batch-to-batch consistency in glycosylation and aggregation profile are critical for downstream formulation performance.

Swapnroop Drugs and Pharmaceuticals coordinates Alemtuzumab supply through our Aurangabad, Maharashtra base with full cold-chain handling and batch-specific quality documentation. We support regulatory dossier compilation, provide validated stability data where available, and serve formulation and research organizations across 25+ countries.

Key Features

  • SEC-HPLC purity ≥98.0% with identity confirmed by SDS-PAGE / Western blot / peptide mapping
  • Validated potency by bioassay with tightly controlled endotoxin and bioburden limits
  • Cold-chain managed storage and transit to preserve protein structure and activity
  • Batch-specific Certificate of Analysis and documentation provided with every shipment

Applications

  • Specialty biologic and biosimilar formulation development programs
  • Hospital and specialty pharmacy supply chains for regulated markets
  • Clinical and pre-clinical research requiring well-characterized reference material
  • Regulatory filing and comparability programs for biosimilar development

Why Choose Swapnroop for Alemtuzumab?

  • Aurangabad, Maharashtra base with validated cold-chain handling and storage infrastructure
  • Regulatory documentation support for import and formulation dossier requirements
  • Batch-specific quality data and available stability information on request
  • Dedicated account management for pharmaceutical and research procurement programs

Packaging & Supply

Alemtuzumab is supplied in validated cold-chain packaging with insulated containers, temperature data loggers, and tamper-evident sealing to preserve product integrity during storage and international transit.

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Frequently Asked Questions about Alemtuzumab

What is the CAS number for Alemtuzumab API?

The CAS number for Alemtuzumab API is 216503-57-9. Please verify the exact salt or hydrate form you require as different forms carry distinct CAS numbers.

What purity and quality standards does Alemtuzumab meet?

Alemtuzumab is supplied to in-house validated specifications with SEC-HPLC purity ≥98.0%, controlled endotoxin and bioburden limits, and potency confirmed by validated bioassay, with full batch-specific documentation.

What is the MOQ and lead time for Alemtuzumab?

Minimum order quantities and lead time for Alemtuzumab depend on batch size and cold-chain logistics requirements; please contact our team for current availability. Standard lead time is 3–6 weeks from confirmation of order, with expedited supply available on request.

Is regulatory documentation available for Alemtuzumab?

Yes, Swapnroop provides batch-specific Certificate of Analysis, MSDS, and available regulatory support documentation for Alemtuzumab to assist with import, formulation, and dossier requirements in your target market.

Alemtuzumab Bulk Supplier in Aurangabad, Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Alemtuzumab supplier serving pharmaceutical formulation and research organizations across India and international markets. Our Aurangabad, Maharashtra based team provides consistent Alemtuzumab sourcing with batch-specific documentation, competitive pricing, and support for domestic and export programs.

Alemtuzumab Exporter from India – Regulatory Filing Support

As a Alemtuzumab exporter from Maharashtra, India, Swapnroop supports organizations worldwide with available Certificate of Analysis, MSDS, and regulatory filing assistance documentation. Contact us for Alemtuzumab pricing, samples, and sourcing support.