Dalteparin bulk supplier for pharma manufacturers

Dalteparin Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 2,500 IU, 5,000 IU, 10,000 IU

Reference Brands: Fragmin (US/EU)

Dalteparin sodium injection, 2,500 IU and 5,000 IU prefilled syringes, a low-molecular-weight heparin used to prevent venous thromboembolism. For hospitals, tender buyers and importers of anticoagulants.

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Product Description:

Dalteparin is a low-molecular-weight heparin, made by controlled breakdown of heparin from porcine intestinal mucosa. It mainly helps antithrombin inhibit factor Xa, with a smaller effect on thrombin, which slows clot formation. Doses are expressed in anti-factor Xa international units. This page covers 2,500 IU and 5,000 IU, the prophylactic strengths, usually in single-dose prefilled syringes for subcutaneous injection. These let nurses give an exact dose quickly, and patients can learn to inject at home.

These doses prevent deep vein thrombosis and pulmonary embolism around surgery and in medical patients with limited mobility. Higher weight-based doses, from other strengths, treat established clots, including extended treatment in cancer. It is injected under the skin, never into muscle. Labels warn of spinal or epidural haematoma with neuraxial anaesthesia. Platelet counts are watched for heparin-induced thrombocytopenia, and a history of it rules dalteparin out. Severe kidney impairment may need anti-Xa monitoring. Units are not interchangeable with other heparins.

Sourcing notes. Regulators treat copies of low-molecular-weight heparins differently, some as biosimilars and some as generics needing sameness data, so check what your authority expects before requesting a dossier. Ask for traceability of the heparin source material, tests for oversulphated chondroitin sulphate, a CoA per batch, the GMP certificate for sterile manufacture and a CoPP. Porcine origin should be declared clearly, as some buyers need it on the label. Prefilled syringes are kept at room temperature, with no cold chain. State strengths, syringes per pack and needle guard needs.

Dalteparin — third party manufacturing & bulk supply

Dalteparin is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.

Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.

Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Dalteparin is supplied as Injection — an injectable dosage form, so the indicative MOQ is 50,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Dalteparin listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Dalteparin is listed as Injection in 2,500 IU, 5,000 IU, 10,000 IU. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Dalteparin is referenced against Fragmin (US/EU). Reference brands are shown for identification only and remain the property of their respective trademark owners.