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olanzapine + samidorphan bulk supplier for pharma manufacturers

Olanzapine + Samidorphan Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, 20 mg/10 mg

Reference Brands: Lybalvi (USA/EU)

Category: Antipsychotropic Drugs

Olanzapine/samidorphan is a fixed‑dose combination medication combining the atypical antipsychotic olanzapine with the opioid receptor antagonist samidorphan. Olanzapine manages psychiatric symptoms such as hallucinations, delusions, mania, or mixed episodes by acting on brain neurotransmitters. Samidorphan helps reduce the risk of weight gain and metabolic side effects commonly seen with olanzapine alone, improving tolerability and long‑term adherence.

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Product Description:

This tablet combines olanzapine, one of the most effective antipsychotics available, with samidorphan, an opioid receptor antagonist. Olanzapine's limitation has always been weight gain and metabolic disturbance, severe enough that many patients stop taking it. Samidorphan blocks mu opioid receptors, and blocking opioid signalling appears to attenuate the weight gain olanzapine causes, without reducing its antipsychotic effect.

It is used for schizophrenia and for bipolar I disorder, as monotherapy or with lithium or valproate. In trials, patients gained meaningfully less weight than on olanzapine alone, though they still gained more than on placebo, so the combination reduces the problem rather than removing it. The important contraindication follows from the opioid blockade: patients using opioids, or in acute opioid withdrawal, must not take it, because samidorphan will precipitate withdrawal, and opioid analgesia will not work normally. It carries olanzapine's warnings, including increased mortality in elderly patients with dementia-related psychosis.

Sourcing notes. Originator product, on patent, no generic — despite olanzapine itself being long off patent, since the combination is protected. Supply is through authorised distribution. Confirm registration in the destination market, which differs from that of plain olanzapine.

Olanzapine + Samidorphan — third party manufacturing & bulk supply

Olanzapine + Samidorphan 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

Olanzapine + Samidorphan 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 Olanzapine + Samidorphan 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

Olanzapine + Samidorphan is used to treat schizophrenia and bipolar I disorder in adults, including acute manic or mixed episodes and for maintenance therapy.

It contains two active components: olanzapine, an atypical antipsychotic, and samidorphan, an opioid‑receptor antagonist.

The trade name is Lybalvi.

It is manufactured by Alkermes, Inc.

The generic name is olanzapine/samidorphan.

The brand name is Lybalvi.

It is manufactured by Alkermes, Inc., with production facilities in Wilmington, Ohio, USA.

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