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Tolvaptan bulk supplier for pharma manufacturers

Tolvaptan 15 mg,30 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 15 mg,30 mg

Reference Brands:

Category: Heart Disorder

Tolvaptan is used in the treatment of low levels of sodium in the blood. It treats low levels of sodium in the blood, which can result from conditions such as heart failure, cirrhosis and syndrome of inappropriate antidiuretic hormone (SIADH).

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Product Description:

Tolvaptan is a selective vasopressin V2 receptor antagonist. Vasopressin normally tells the kidney's collecting ducts to reabsorb water; blocking its receptor produces aquaresis — excretion of water without sodium and potassium. That is what distinguishes it from diuretics, which lose electrolytes along with the water.

At 15 mg and 30 mg it is used for clinically significant hypervolaemic and euvolaemic hyponatraemia, including the syndrome of inappropriate antidiuretic hormone secretion, and in heart failure and cirrhosis. It is started in hospital so that sodium can be measured frequently: correcting sodium too quickly risks osmotic demyelination syndrome, a severe and often irreversible neurological injury, so the rate of rise is limited and fluid restriction is lifted while the drug is given. Thirst, dry mouth and frequent urination are expected. It is a CYP3A4 substrate, so strong inhibitors are avoided. A separate, higher-dose product is used for polycystic kidney disease and carries liver-injury monitoring requirements.

Sourcing notes. Off patent for the hyponatraemia product, with generics in the US and elsewhere. The polycystic kidney disease product is a different registration with restricted distribution. Buyers should state which indication they are supplying for.

Tolvaptan — third party manufacturing & bulk supply

Tolvaptan 15 mg,30 mg 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

Tolvaptan is supplied as Tablets — an oral solid dosage form, so the indicative MOQ is 200,000 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 Tolvaptan 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

Tolvaptan is listed as Tablets in 15 mg,30 mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

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