Active Pharmaceutical Ingredient

Palivizumab — CAS 216995-50-1

Also known as: Synagis (brand); Anti-RSV monoclonal antibody

GMP Certified IP / BP / USP Monoclonal Antibody / Antiviral Agent Aurangabad, India
Palivizumab API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Palivizumab IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 216995-50-1

Product Overview

Palivizumab is a humanized monoclonal antibody directed against an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Manufactured by Mediocon Inc at its GMP-certified facility in Maharashtra, India, it is used for prophylaxis of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk.

Therapeutic Applications
  • Prevention of RSV infections in premature infants and neonates
  • Prophylaxis of serious RSV lower respiratory tract disease
  • Used in pediatric patients with congenital heart disease
  • Management of bronchopulmonary dysplasia in high-risk infants

Technical Specifications

ParameterSpecification
CAS Number216995-50-1
Molecular FormulaC6499H9917N1717O2014S46
Molecular Weight~149,000 g/mol
GradeIP / BP / USP
CategoryMonoclonal Antibody / Antiviral Agent
AppearanceWhite to off-white lyophilized powder
SolubilityFreely soluble in water, slightly soluble in phosphate buffered saline
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPAV/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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