Isotretinoin bulk supplier for pharma manufacturers

Isotretinoin 10mg, 20mg, 30mg, Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 10mg, 20mg, 30mg,

Reference Brands: Roaccutane (EU)

Isotretinoin is a retinoid used for severe, recalcitrant nodular acne that does not respond to conventional therapy. It works by reducing sebaceous gland activity, decreasing inflammation, and preventing acne formation. It is highly effective but requires careful monitoring due to potential side effects and pregnancy-related risks.

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Product Description:

Isotretinoin is 13-cis-retinoic acid, the only drug that addresses all four drivers of acne at once: it shrinks sebaceous glands and cuts sebum production dramatically, normalises the abnormal keratinisation that blocks follicles, reduces Cutibacterium acnes as a consequence of the drier environment, and is anti-inflammatory. A single course often produces lasting remission, which no other acne treatment achieves.

It is used for severe nodular or recalcitrant acne, and in many markets for acne causing scarring or serious psychological distress, dosed by body weight to a cumulative target over sixteen to twenty-four weeks. Adverse effects are near-universal but manageable: dry lips, skin and eyes, nosebleeds, muscle aches, raised triglycerides and liver enzymes, and photosensitivity. The defining issue is teratogenicity — exposure in early pregnancy causes severe malformations of the brain, heart and face — and reports of mood change and depression require monitoring and discussion.

Sourcing notes. Every regulated market registers isotretinoin inside a mandatory pregnancy prevention programme covering prescriber and pharmacy registration, pregnancy testing, contraception and limited dispensing quantities. A buyer cannot distribute it as an ordinary generic; the programme requirements must be met in the destination market. Off patent, with many manufacturers.

Isotretinoin — third party manufacturing & bulk supply

Isotretinoin 10mg, 20mg, 30mg, 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

Isotretinoin is supplied as Capsules — 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 Isotretinoin 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

Isotretinoin is used to treat severe acne, particularly nodular or cystic acne that does not respond to other treatments. It reduces oil production, prevents clogging of pores, and decreases inflammation, helping achieve long-term acne clearance.

Isotretinoin is made from the active ingredient isotretinoin, which is a retinoid derived from vitamin A. It works by shrinking sebaceous glands and regulating skin cell turnover.

Common global trade names include Accutane, Roaccutane, Claravis, Amnesteem, Zenatane, Myorisan, and Absorica.

Various companies manufacture isotretinoin depending on the region, including Roche (original developer under Roaccutane) and multiple approved generic manufacturers worldwide.

The generic name is isotretinoin.

Brand names include Accutane, Roaccutane, Claravis, Amnesteem, Zenatane, Myorisan, and Absorica.

Isotretinoin is manufactured by several pharmaceutical companies across different countries, including the United States, Europe, and India, depending on the brand and marketing authorization.