Product Name: Rituximab 500 mg/50 mL
Generic Name: Rituximab
Strength: 500 mg/50 mL
Concentration: 10 mg/mL
Dosage Form: Injection / Concentrate for Solution for Infusion
Route of Administration: Intravenous infusion
Pack Presentation: Single-dose vial
Therapeutic Category: Oncology / Immunology / Monoclonal Antibody
Prescription Status: Prescription medicine
Active Ingredient: Rituximab
Rituximab 500 mg/50 mL is a monoclonal antibody targeting the CD20 antigen on B lymphocytes. The 500 mg/50 mL presentation is supplied as a 10 mg/mL solution for intravenous infusion. WHO has listed a 500 mg/50 mL rituximab product manufactured by Dr. Reddy's Laboratories in India in its prequalification assessment documentation.
Product Specifications
| Specification | Details |
|---|---|
| Generic Name | Rituximab |
| Strength | 500 mg/50 mL |
| Concentration | 10 mg/mL |
| Dosage Form | Injection / Concentrate for Solution for Infusion |
| Route | Intravenous |
| Container | Single-dose vial |
| Category | Monoclonal Antibody / Oncology |
| Storage | Refrigerated storage as specified on the approved product label |
| Prescription | Required |
The U.S. product information identifies rituximab 500 mg/50 mL as a single-dose vial containing 10 mg/mL and intended for intravenous use after appropriate preparation/dilution.
Therapeutic Applications
Rituximab products are used under specialist medical supervision for several B-cell–mediated and hematologic conditions. Approved indications vary by product and country and may include certain types of:
- Non-Hodgkin lymphoma
- Chronic lymphocytic leukemia
- Rheumatoid arthritis
- Granulomatosis with polyangiitis
- Microscopic polyangiitis
- Pemphigus vulgaris
The exact indication, dosage regimen and eligibility depend on the approved label in the destination market.
Export Supply from India
We provide pharmaceutical sourcing and export assistance for Rituximab 500 mg/50 mL from India, subject to manufacturer availability, destination-country registration requirements, import regulations and applicable pharmaceutical laws.
Potential markets include:
North America: USA, Canada, Mexico
Europe: UK, Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Norway, Denmark, Finland, Ireland, Portugal, Poland, Czech Republic, Hungary, Romania
Middle East: UAE, Saudi Arabia, Qatar, Kuwait, Oman, Bahrain, Israel
Asia: Singapore, Malaysia, Thailand, Japan, South Korea, China, Hong Kong, Philippines, Vietnam, Cambodia, Myanmar, Bangladesh, Sri Lanka, Nepal, Pakistan, Indonesia
Oceania: Australia, New Zealand
Africa: South Africa, Nigeria, Kenya, Ghana, Tanzania, Uganda, Egypt
Latin America: Brazil, Argentina, Colombia, Chile, Peru, Ecuador, Bolivia, Paraguay, Uruguay
Other International Markets: Turkey, Russia and additional eligible international destinations.
Cold-Chain & Storage
Rituximab products generally require controlled refrigerated storage. For example, the U.S. labeling for rituximab products specifies storage at 2°C–8°C, with protection from direct sunlight and instructions not to freeze or shake. Destination-market and manufacturer-specific labeling should always be followed.
Quality & Documentation
Depending on the destination market and transaction, export documentation may include:
- Commercial Invoice
- Packing List
- Certificate of Origin
- Batch Certificate / Certificate of Analysis
- Product documentation
- Manufacturer documentation
- Shipping and cold-chain documentation
- Importer or consignee regulatory documentation
- Other documents required by the destination authority
Important Regulatory Notice
Rituximab is a prescription biologic medicine. Availability, brand, registration, import authorization, indications and export eligibility differ between countries. Buyers, hospitals, distributors and licensed pharmaceutical importers should verify all applicable regulatory requirements before ordering.
Enquire About Rituximab 500 mg/50 mL
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MEDINDIA EXPORT – Pharmaceutical Export & International Supply from India
