Darzalex (Daratumumab)
Introduction
International pharmaceutical procurement requires reliable suppliers, accurate product information, appropriate quality documentation, and compliance with destination-country regulations. These considerations are particularly important for oncology medicines, including biologic therapies that require specialized handling and controlled transportation.
Darzalex (daratumumab) is a prescription monoclonal antibody used in the treatment of multiple myeloma, a cancer affecting plasma cells. For pharmaceutical importers, hospital procurement departments, oncology medicine distributors, and authorized healthcare organizations, sourcing this medicine requires careful verification of the product presentation, manufacturer, storage conditions, documentation, and import eligibility.
India has an established pharmaceutical industry with companies involved in finished formulations, biologic medicines, and international pharmaceutical distribution. However, the availability of a specific biologic product or branded medicine must be confirmed individually.
Dolphin Pharmaceuticals, based in Surat, Gujarat, India, provides a contact point for international pharmaceutical sourcing enquiries. Buyers interested in Darzalex or other daratumumab products can enquire about potential supply options, subject to confirmation of product availability, manufacturer, documentation, and applicable export requirements.
This guide explains how to evaluate a Darzalex (daratumumab) exporter from India and what international pharmaceutical buyers should check before proceeding with a purchase.
Key Highlights
- Brand name: Darzalex.
- Generic name: Daratumumab.
- Therapeutic category: Oncology biologic medicine; monoclonal antibody.
- Primary disease area: Multiple myeloma, according to applicable product labeling.
- Intravenous presentations: Commonly referenced strengths include 100 mg/5 mL and 400 mg/20 mL.
- Administration: Intravenous Darzalex is administered by qualified healthcare professionals following the approved instructions.
- Storage: The intravenous product generally requires refrigerated storage at 2°C–8°C and protection from light; verify the exact product label.
- Buyer priorities: Manufacturer verification, product authenticity, quality documentation, cold-chain handling, and regulatory compliance.
- Supplier assessment: Confirm current availability, exact formulation, manufacturer, quotation, and export eligibility.
- Destination-market requirements: Registration, import permits, and importer authorization must be verified before shipment.
Understanding Darzalex (Daratumumab)
Daratumumab is a monoclonal antibody that targets CD38, a protein expressed on multiple myeloma cells and certain other cells. It is used in approved treatment regimens for multiple myeloma, depending on the product label, disease setting, and treatment combination.
Darzalex is a prescription medicine that must be used under appropriate specialist supervision. Its clinical use, dosing schedule, and suitability for an individual patient are determined by qualified healthcare professionals.
For pharmaceutical buyers, the priority is to identify the exact product and formulation required by the receiving healthcare organization.
Product Details
- Brand name: Darzalex.
- Generic name: Daratumumab.
- Medicine type: Monoclonal antibody; biologic oncology medicine.
- Therapeutic category: Anticancer medicine.
- Commonly referenced indication: Multiple myeloma, according to approved product labeling.
- Intravenous dosage form: Concentrate for solution for infusion.
- Common intravenous presentations: 100 mg/5 mL and 400 mg/20 mL.
- Administration route: Intravenous infusion for the intravenous formulation.
- Storage: Generally refrigerated at 2°C–8°C and protected from light for the referenced intravenous product; confirm current local labeling.
- Packaging: Vial configuration and pack details depend on the specific product and market.
- Availability: Must be confirmed directly with the proposed supplier.
- Export eligibility: Depends on the product, manufacturer, exporter, and destination-country requirements.
These details describe commonly referenced intravenous Darzalex presentations. They should not be applied automatically to other daratumumab products or formulations.
Darzalex and Other Daratumumab Formulations: Why Buyers Must Check Carefully
A pharmaceutical buyer should not assume that every product containing daratumumab is identical.
The intravenous formulation of Darzalex is supplied as a concentrate for infusion. A separate subcutaneous daratumumab formulation is also marketed in certain countries under different product names and labeling.
The formulations may differ in concentration, presentation, administration route, preparation requirements, and approved product information.
Before accepting a quotation, buyers should verify:
- Exact brand and generic name.
- Intravenous or subcutaneous formulation.
- Strength and concentration.
- Volume per vial or prefilled presentation, where applicable.
- Actual manufacturer and manufacturing site.
- Approved product labeling for the destination market.
- Storage and transportation requirements.
- Product registration and import eligibility.
This distinction is essential when comparing quotations and reviewing product documentation. A product with the same active ingredient should not be treated as automatically interchangeable with another presentation.
Why Choosing a Reliable Daratumumab Exporter Matters
Biologic oncology medicines require careful procurement and supply-chain management. Buyers should assess the proposed supplier using verifiable product information rather than relying solely on marketing claims or price.
1. Product Authenticity
Confirm that the product offered matches the requested brand, formulation, strength, and packaging.
Request supporting information that allows the buyer to verify the product's identity and traceability. The product label, manufacturer information, batch details, and accompanying documentation should be consistent.
2. Manufacturer Transparency
Determine the actual manufacturer of the proposed medicine and clarify the supplier's role in the transaction.
An exporter may manufacture a product, distribute a third-party manufacturer's product, or act as a sourcing intermediary. These roles should be clearly established before an order is confirmed.
For branded biologic medicines, buyers should verify that the offered product is genuine and that the proposed supply channel is appropriate for the intended market.
3. Quality Documentation
Request the product and batch documentation applicable to the medicine and transaction.
Depending on the destination market and procurement requirements, this may include:
- Product specifications.
- Manufacturer and manufacturing-site information.
- Batch details and expiry information.
- Certificate of Analysis, where applicable.
- Relevant manufacturing or quality certificates.
- Product registration or approval documentation.
- Applicable traceability records.
The exact requirements should be confirmed with the importer and relevant regulatory authorities.
4. Cold-Chain Capability
The intravenous Darzalex product generally requires refrigerated storage and protection from light. Maintaining the required conditions throughout transportation is therefore a major procurement consideration.
Buyers should establish whether the proposed logistics arrangements can meet the product's labeled storage requirements and whether suitable temperature monitoring and shipment documentation are available.
5. Regulatory Compliance
The medicine must meet the applicable requirements in both the exporting and destination markets.
Before shipment, buyers should confirm the product's authorization status, import permit requirements, importer eligibility, labeling rules, and other applicable conditions.
Dolphin Pharmaceuticals: Pharmaceutical Sourcing from India
Dolphin Pharmaceuticals, based in Surat, Gujarat, India, provides an enquiry channel for international pharmaceutical buyers interested in sourcing finished medicines.
Its published catalogue includes selected oncology products, but the publicly listed information reviewed for this article does not confirm current availability of Darzalex or a specific daratumumab formulation.
International buyers should therefore contact the company to determine whether the requested branded product or another suitable, authorized daratumumab product can be considered for supply.
Before proceeding, request confirmation of:
- Whether the exact requested product can be supplied or sourced.
- Brand name and generic composition.
- Formulation, strength, and vial presentation.
- Actual manufacturer and manufacturing site.
- Current availability and quotation.
- Applicable product and batch documentation.
- Cold-chain and transportation arrangements.
- Remaining shelf life at dispatch.
- Export eligibility for the destination market.
- Expected lead time and commercial terms.
These checks help buyers assess the proposed supply arrangement without assuming that a particular brand or formulation is available.
How to Choose a Reliable Darzalex Exporter from India
Selecting a pharmaceutical exporter requires a structured assessment of the supplier, product, documentation, and shipment arrangements.
Step 1: Define the Exact Product Requirement
Specify whether the requirement is for branded Darzalex or another authorized daratumumab product.
Include the formulation, strength, vial size, required quantity, destination country, and any manufacturer preference. This helps prevent confusion between intravenous and subcutaneous presentations.
Step 2: Verify Supplier Credentials
Review the supplier's legal business details, relevant licences, and role in the pharmaceutical supply chain.
Where required, verify that the manufacturer, exporter, and importer hold the authorizations necessary for the proposed transaction.
Do not rely on a general product catalogue alone as evidence that a specific biologic medicine is currently available or authorized for export.
Step 3: Request Product Documentation
Ask for the documentation applicable to the exact product and batch.
Confirm that the brand, generic name, formulation, strength, manufacturer, batch number, expiry information, and other relevant details are consistent across the documents.
Resolve any discrepancies before confirming the order or approving dispatch.
Step 4: Review Cold-Chain Arrangements
Request the manufacturer's storage instructions and establish how the product will be protected during transit.
For the referenced intravenous product, buyers should confirm the applicable refrigerated storage range, protection-from-light requirements, and any permitted transport excursions specified in the current product labeling.
Where required, establish how temperature monitoring, shipment records, and excursion assessment will be managed.
Step 5: Compare Complete Quotations
Compare offers using the same product presentation and commercial assumptions.
Consider product price, quantity, packaging, documentation, cold-chain transport, insurance where applicable, payment terms, and expected delivery time.
A low price alone does not establish product authenticity, appropriate handling, or supplier reliability.
Step 6: Confirm Destination-Market Eligibility
Before placing an order, verify whether the exact product is registered or otherwise authorized in the destination country.
Confirm the applicable import permits, importer authorization, labeling requirements, and any additional conditions for biologic medicines.
Complete the required regulatory checks before shipment.
Cold-Chain Storage and Transportation Considerations
Cold-chain management is one of the most important aspects of sourcing the intravenous Darzalex formulation.
The referenced intravenous product is generally stored at 2°C–8°C and protected from light. The exact manufacturer's current product labeling must govern storage and transport decisions.
Before dispatch, buyers should confirm:
- Required storage temperature.
- Protection from light.
- Suitable insulated packaging and shipping arrangements.
- Temperature-monitoring requirements, where applicable.
- Product expiry date and remaining shelf life.
- Procedures for reviewing temperature excursions.
- Documentation accompanying the shipment.
- Arrangements for prompt receipt and appropriate storage after delivery.
The exporter, logistics provider, and importer should agree on the handling process before dispatch. If a shipment experiences a temperature excursion, the product should not be assumed suitable for use without an assessment under the applicable product guidance and quality procedures.
Pharmaceutical Export and Import Requirements
Pharmaceutical import requirements vary according to the product, destination country, and nature of the transaction.
For Darzalex or another daratumumab product, buyers should establish:
- Whether the product is registered or otherwise authorized in the destination market.
- Whether an import permit or additional authorization is required.
- Whether the importing organization is appropriately licensed.
- Which product, manufacturer, and quality documents must be submitted.
- Whether labeling and packaging meet local requirements.
- Which export, shipping, customs, and cold-chain documents are necessary.
The exporter should clarify which documents it can provide, while the importer should confirm the applicable requirements with the relevant authorities and qualified regulatory partners.
Important: Availability in one market does not automatically authorize importation or sale in another country. A branded medicine and a different daratumumab product may also have distinct registration and supply conditions.
Documents International Buyers May Need
Documentation requirements depend on the product, destination country, and transaction.
Product and Quality Documents
- Product specifications.
- Manufacturer and manufacturing-site details.
- Batch number and expiry information.
- Certificate of Analysis, where applicable.
- Relevant manufacturing or quality certificates.
- Product labeling and packaging information.
- Applicable registration or approval records.
- Traceability information, where required.
Commercial Documents
- Proforma invoice.
- Commercial invoice.
- Packing list.
- Purchase order and agreed sales terms.
- Applicable shipping documentation.
Regulatory and Cold-Chain Documents
- Import permit or other applicable authorization.
- Required regulatory certificates.
- Cold-chain shipping records, where applicable.
- Temperature-monitoring records, where required.
- Supporting documentation for customs clearance.
Not every document applies to every shipment. Buyers should establish a product-specific checklist with their regulatory and logistics partners before confirming an order.
Common Challenges When Sourcing Daratumumab
International buyers may encounter several challenges when sourcing biologic oncology medicines.
Unconfirmed Availability
A supplier's general oncology portfolio does not establish that Darzalex or another specific daratumumab product is available. Obtain written confirmation before making procurement commitments.
Confusion Between Formulations
Intravenous and subcutaneous formulations have different presentations and administration requirements. Verify the precise product before comparing offers.
Incomplete Manufacturer Information
If the actual manufacturer or product origin is unclear, request clarification before proceeding.
Cold-Chain Disruptions
Inadequate temperature control may compromise the suitability of a biologic medicine. Confirm transport arrangements and the procedures for managing temperature excursions.
Regulatory Delays
Incomplete product documents or missing import authorization can delay shipment and customs clearance. Establish the requirements early in the procurement process.
How to Request a Quotation from Dolphin Pharmaceuticals
International pharmaceutical buyers can prepare a detailed enquiry to help Dolphin Pharmaceuticals assess the request.
Include the following information:
- Requested product: Darzalex (daratumumab) or another specified daratumumab product.
- Formulation: Intravenous or subcutaneous, as required.
- Strength and presentation: Specify the required vial or product configuration.
- Quantity: Expected order volume.
- Destination country: Intended import market.
- Manufacturer preference: If applicable.
- Documentation: Required quality and regulatory documents.
- Storage and shipping: Any specified cold-chain or handling requirements.
- Delivery expectations: Preferred shipment timeline.
Ask the company to confirm whether the exact product can be supplied or sourced, identify the manufacturer, provide the available product documentation, and clarify export eligibility.
All product specifications, commercial terms, and regulatory requirements should be verified before an order is finalized.
Frequently Asked Questions
1. What is Darzalex (daratumumab) used for?
Darzalex is a prescription monoclonal antibody used in approved treatment regimens for multiple myeloma. The appropriate treatment depends on the product labeling and the assessment of qualified healthcare professionals.
2. What are the common intravenous presentations of Darzalex?
Commonly referenced intravenous presentations include 100 mg/5 mL and 400 mg/20 mL. Buyers should verify the exact product presentation and approved labeling for the intended market.
3. Is Darzalex the same as every other daratumumab product?
No. Products containing the same active ingredient may differ in brand, formulation, presentation, labeling, and regulatory status. Buyers should verify the exact product requested.
4. Does Dolphin Pharmaceuticals currently supply Darzalex?
Current availability of Darzalex or another daratumumab formulation should be confirmed directly with Dolphin Pharmaceuticals. Its published catalogue does not, by itself, establish current availability of this specific product.
5. What storage conditions apply to intravenous Darzalex?
The referenced intravenous product generally requires storage at 2°C–8°C and protection from light. The current product labeling must be checked for the exact formulation and destination market.
6. What documents should buyers request?
Depending on the transaction, buyers may need product specifications, manufacturer information, batch documentation, a Certificate of Analysis where applicable, relevant quality certificates, commercial invoices, packing lists, regulatory permits, and cold-chain records where required.
7. Can Darzalex be exported from India to every country?
No. Export and import eligibility depend on the specific product, applicable laws, destination-market authorization, and the parties' regulatory status. Buyers should verify the requirements before shipment.
8. What should buyers compare when evaluating suppliers?
Compare product authenticity, manufacturer transparency, quality documentation, cold-chain arrangements, remaining shelf life, commercial terms, delivery expectations, and regulatory compliance. Price should not be the only selection criterion.
Conclusion
Choosing a reliable Darzalex (Daratumumab) exporter from India requires careful evaluation of product authenticity, manufacturer information, quality documentation, cold-chain capability, commercial transparency, and destination-market regulatory requirements.
Dolphin Pharmaceuticals, based in Surat, Gujarat, India, can be contacted to discuss international pharmaceutical sourcing enquiries. However, current availability of Darzalex or another daratumumab product, the actual manufacturer, supporting documentation, and export eligibility must be confirmed directly before an order is placed.
For pharmaceutical importers, oncology distributors, and authorized healthcare procurement organizations, a clear product specification and a structured supplier verification process can help support a responsible sourcing decision.
Contact Dolphin Pharmaceuticals with your required daratumumab formulation, strength, quantity, and destination country to enquire about potential sourcing options and product-specific export requirements.
Disclaimer: This article is intended for pharmaceutical procurement and general informational purposes only. It does not provide medical advice or guarantee product availability, manufacturing status, regulatory approval, or export eligibility. Daratumumab must be used under appropriate specialist supervision and handled according to the applicable product labeling.
My Company Name - Dolphin Pharmaceuticals
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