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Levoketoconazole bulk supplier for pharma manufacturers

Levoketoconazole 150 mg ,300 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 150 mg ,300 mg

Reference Brands: Recorlev (USA)

Category: Anti-fungal

Levoketoconazole is a Anti-fungal product available as Tablets in strengths 150 mg ,300 mg. It corresponds to the reference brand Recorlev (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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Product Description:

Levoketoconazole is an orally available levorotatory enantiomer of ketoconazole, developed for the treatment of endogenous Cushing’s syndrome. It works as a steroidogenesis inhibitor by selectively targeting key enzymes in cortisol biosynthesis, including 11β-hydroxylase (CYP11B1), 17α-hydroxylase/17,20-lyase (CYP17A1), and steroid 21-hydroxylase (CYP21A2). By inhibiting these enzymes, levoketoconazole reduces circulating cortisol levels, helping to normalize hypercortisolemia in patients with Cushing’s syndrome.

Compared to racemic ketoconazole, levoketoconazole is more potent in suppressing glucocorticoid synthesis while being less likely to inhibit cholesterol 7α-hydroxylase (CYP7A1), which may lower the risk of hepatotoxicity. This makes it a safer and more targeted option for long-term management of elevated cortisol. Levoketoconazole is particularly indicated for adult patients with Cushing’s syndrome for whom surgery is not an option or has been unsuccessful. Its oral tablet formulation allows for convenient administration, and treatment requires monitoring of cortisol levels and liver function under medical supervision. This agent provides an effective pharmacological approach to controlling the complications of chronic hypercortisolism.

Levoketoconazole — third party manufacturing & bulk supply

Levoketoconazole 150 mg ,300 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.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Indicative minimum order quantity

Levoketoconazole 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 Levoketoconazole listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions

Levoketoconazole is used for the treatment of endogenous Cushing’s syndrome in adult patients, particularly when surgery is not an option or has been unsuccessful.

Levoketoconazole is a synthetically manufactured enantiomer of ketoconazole that inhibits key enzymes involved in cortisol biosynthesis.

The trade name of levoketoconazole is Recorlev.

Recorlev is developed and marketed by Strongbridge Biopharma.

The generic name of Levoketoconazole is levoketoconazole.

The brand name of Levoketoconazole is Recorlev.

Levoketoconazole oral tablets are manufactured in GMP-compliant pharmaceutical facilities in the USA and EU, depending on the marketing region.

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