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Osilodrostat bulk supplier for pharma manufacturers

Osilodrostat 1mg, 5mg, 10mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 1mg, 5mg, 10mg

Reference Brands: Isturisa (USA/EU)

Category: Critical Care

Osilodrostat is a cortisol synthesis inhibitor used to treat endogenous Cushing’s syndrome. It works by blocking 11β-hydroxylase, an enzyme required for cortisol production, helping restore hormonal balance. It offers an effective oral option for patients who cannot undergo surgery or need medical control before or after surgical intervention.

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Product Description:

Osilodrostat blocks 11-beta-hydroxylase, the final enzyme in cortisol synthesis in the adrenal cortex. Unlike treatments aimed at the pituitary tumour, it acts on the adrenal gland itself, so it lowers cortisol whatever the underlying cause of the excess. It also inhibits aldosterone synthase, which is the source of some of its adverse effects.

It is used for endogenous Cushing's syndrome in adults for whom surgery is not an option or has not worked. Cortisol levels are measured and the dose titrated until they normalise, which is the essence of treatment: too little cortisol causes adrenal insufficiency, with nausea, fatigue and hypotension, and patients are taught to recognise it. Blocking the pathway also causes precursor steroids to accumulate, which raises androgens — hirsutism and acne in women — and blocks aldosterone, causing low potassium and raised blood pressure from intermediate steroids. QT prolongation requires an ECG before and during treatment.

Sourcing notes. Originator product, on patent, no generic. It competes with metyrapone, ketoconazole and pasireotide in a small, specialist market. Use requires biochemical monitoring capability, so a destination market without reliable cortisol assays cannot manage it. Supply is through authorised distribution.

Osilodrostat — third party manufacturing & bulk supply

Osilodrostat 1mg, 5mg, 10mg 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

Osilodrostat 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 Osilodrostat 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

Osilodrostat is used to treat Cushing’s disease by reducing excess cortisol levels in the body. It is prescribed for patients who cannot undergo pituitary surgery or for whom surgery has not been successful. By lowering cortisol, it helps improve symptoms such as weight gain, fatigue, high blood pressure, and metabolic disturbances.

Osilodrostat is made from the active substance osilodrostat phosphate, which works as an inhibitor of the enzyme 11β-hydroxylase. This enzyme is responsible for the final step in cortisol synthesis, and blocking it helps reduce cortisol production.

The trade name of osilodrostat is Isturisa.

Osilodrostat (Isturisa) is manufactured by Recordati Rare Diseases, which holds authorization in several global markets.

The generic name is osilodrostat phosphate.

The brand name is Isturisa.

Osilodrostat is manufactured at authorized Recordati production facilities and approved contract manufacturing sites located in Europe, depending on regulatory requirements.

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