Pertuzumab 420 mg/14 mL
Introduction
Biological medicines require careful sourcing, storage, transportation, and regulatory oversight. For pharmaceutical importers, hospital procurement departments, oncology distributors, and institutional buyers, selecting a suitable supplier involves more than confirming the product name and price.
Pertuzumab is a monoclonal antibody used in selected HER2-positive breast cancer treatment regimens. The commonly referenced presentation is a 420 mg/14 mL concentrate for solution for infusion, at a concentration of 30 mg/mL. Because it is a biological medicine, product identity, cold-chain handling, and documentation require particular attention.
Dolphin Pharmaceuticals, based in Surat, Gujarat, India, offers pharmaceutical products across multiple therapeutic categories. International buyers can contact the company to enquire about potential sourcing options for pertuzumab 420 mg/14 mL, subject to confirmation of the exact product, manufacturer, availability, and export eligibility.
Key Product Highlights
- Generic name: Pertuzumab.
- Strength: 420 mg/14 mL.
- Concentration: 30 mg/mL for the referenced presentation.
- Dosage form: Concentrate for solution for intravenous infusion.
- Therapeutic category: Monoclonal antibody; antineoplastic biologic.
- Use: Selected HER2-positive breast cancer regimens, according to the applicable approved product information.
- Packaging: Commonly supplied in a single-dose vial; confirm the exact presentation.
- Storage: The referenced Perjeta product is refrigerated at 2°C to 8°C, protected from light, and must not be frozen or shaken. Confirm the label for the actual product supplied.
- Important procurement checks: Manufacturer, product approval, batch documentation, cold-chain capability, shelf life, and import authorisation.
Understanding Pertuzumab 420 mg/14 mL
Pertuzumab is a humanised monoclonal antibody that targets HER2. It is used in combination treatment for selected patients with HER2-positive breast cancer, depending on the disease setting and the applicable product approval.
The 420 mg/14 mL presentation is a concentrate for solution for infusion, not a ready-to-administer injection for direct use. It is intended for preparation and administration by qualified healthcare professionals according to the approved product instructions.
Buyers should distinguish pertuzumab alone from combination products containing pertuzumab and trastuzumab. These are different presentations with different product specifications and handling requirements.
Product details to confirm
- Generic name: pertuzumab.
- Strength and concentration: 420 mg/14 mL, 30 mg/mL for the referenced presentation.
- Dosage form: concentrate for solution for intravenous infusion.
- Actual manufacturer and manufacturing site.
- Brand or product name, where applicable.
- Vial and pack configuration.
- Batch number, expiry date, and remaining shelf life.
- Approved storage and handling conditions.
- Product registration and import eligibility.
- Cold-chain shipping arrangements.
Why Cold-Chain Management Matters
Pertuzumab is a biological medicine that requires product-specific handling. For the referenced Perjeta presentation, unopened vials are stored at 2°C to 8°C in the original carton to protect them from light. The product must not be frozen or shaken.
Requirements for other pertuzumab products must be confirmed from their own approved labels. Buyers should never assume that every manufacturer or presentation has identical storage instructions.
Before approving a shipment, confirm:
- Refrigerated transport requirements.
- Packaging suitable for the required temperature range.
- Temperature-monitoring procedures, where applicable.
- Handling of customs delays and transit interruptions.
- Product-specific shelf-life requirements.
- Documentation of any required cold-chain controls.
The exporter, importer, and logistics provider should agree on responsibilities before dispatch.
Quality Documentation and Manufacturer Verification
Confirm the actual manufacturer
Verify the legal name of the manufacturer and the manufacturing site. The exporter may not be the same organisation as the manufacturer.
Review product and batch records
Depending on the product and transaction, buyers may need product specifications, batch information, Certificate of Analysis where applicable, manufacturing details, and relevant quality certificates.
Verify regulatory status
Confirm whether the exact product is registered or otherwise authorised in the destination market. Import permits and additional authorisations may apply.
Inspect packaging and traceability
Check product identity, batch number, expiry date, vial integrity, labelling, and any cold-chain records required by the importer or relevant authority.
Confirm handling and shipping plans
Obtain written confirmation of the storage range, shipping method, packaging, estimated transit time, and responsibilities for monitoring and receiving the shipment.
Indian Supply Options and Dolphin Pharmaceuticals
India has pharmaceutical manufacturers and suppliers involved in biological and oncology medicines. The Central Drugs Standard Control Organisation publishes information about regulatory permissions for biological products, including pertuzumab presentations. However, a regulatory listing for a manufacturer does not establish that Dolphin Pharmaceuticals stocks or exports that specific product.
Buyers should contact Dolphin Pharmaceuticals to confirm whether the required pertuzumab presentation can be sourced and to request:
- Exact product and manufacturer details.
- Current availability and quotation.
- Relevant product and batch documentation.
- Regulatory documents applicable to the transaction.
- Cold-chain packaging and shipping arrangements.
- Destination-market export eligibility.
- Estimated lead time and delivery conditions.
Regulatory Compliance for International Buyers
Before placing an order, buyers should establish whether the destination country requires product registration, import permits, importer authorisation, or other regulatory documentation.
For biological medicines, procurement requirements may also include product-specific quality information and evidence that storage and transportation conditions are suitable.
A product authorised in India is not automatically authorised for import or sale in another country. Buyers should verify the applicable requirements with the relevant destination-country authority before dispatch.
Frequently Asked Questions
What is pertuzumab 420 mg/14 mL used for?
Pertuzumab is used in selected HER2-positive breast cancer treatment regimens, according to the applicable product approval and specialist treatment plan.
Is pertuzumab 420 mg/14 mL a ready-to-use injection?
The referenced presentation is a concentrate for solution for intravenous infusion. It must be prepared and administered by qualified healthcare professionals according to the approved instructions.
Does pertuzumab require refrigeration?
The referenced Perjeta product requires storage at 2°C to 8°C, protection from light, and protection from freezing. Confirm the approved label for the exact product being sourced.
Can pertuzumab be exported from India?
Potential supply depends on product availability, regulatory approvals, destination-market requirements, and the ability to maintain the necessary handling conditions.
Does Dolphin Pharmaceuticals currently stock pertuzumab?
Availability must be confirmed directly with the company. Buyers should specify the exact 420 mg/14 mL presentation and destination country.
Conclusion
Sourcing pertuzumab 420 mg/14 mL from India requires careful manufacturer verification, product documentation, regulatory review, and a suitable cold-chain plan.
Dolphin Pharmaceuticals can be contacted to discuss potential sourcing requirements. Buyers should confirm the exact product, manufacturer, current availability, quality documentation, storage conditions, and destination-market eligibility before finalising an order.
For international pharmaceutical buyers, a documented procurement process and early coordination with the importer and logistics provider can help reduce avoidable delays and support responsible handling of this specialist biologic medicine.
Disclaimer: This article is intended for pharmaceutical procurement and general informational purposes only. Pertuzumab is a prescription biologic medicine that must be prepared and administered by qualified healthcare professionals.
My Company Name - Dolphin Pharmaceuticals
My Website - https://www.dolphinpharma.in/