Midazolam Nasal spray bulk supplier for pharma manufacturers

Midazolam Nasal Spray 2.5 mg, 5 mg, 7.5 mg, 10 mg Suppliers & Bulk Manufacturers

Available Forms: Nasal/Buccal

Available Strengths: 2.5 mg, 5 mg, 7.5 mg, 10 mg

Reference Brands: Nayzilam (nasal spray)(US)

Midazolam nasal spray and buccal oromucosal solution, 2.5 mg to 10 mg, rescue forms for acute seizures given outside hospital. For licensed importers, distributors and hospitals holding controlled-drug permits.

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Product Description:

Midazolam is a short-acting benzodiazepine that strengthens the effect of GABA at the GABA-A receptor, calming excess electrical activity in the brain. This page covers two seizure rescue forms for use outside hospital: a single-use nasal spray, and oromucosal solution in prefilled oral syringes given inside the cheek. The 2.5 mg, 5 mg, 7.5 mg and 10 mg strengths match the age bands for the buccal syringes. Both let a parent, carer or teacher give a dose without an injection or rectal tube.

The nasal spray is approved in some markets for seizure clusters in patients aged 12 and over. The buccal solution is licensed for prolonged acute convulsive seizures in children from three months to under 18 years, dosed by age: 2.5 mg for infants, then 5 mg, 7.5 mg and 10 mg as the child grows. The main risk is respiratory depression, greater with opioids, alcohol or other sedatives. Strong CYP3A4 inhibitors raise midazolam levels.

Sourcing notes. Midazolam is a controlled medicine in many countries. The UK lists it under Schedule 3. Supply moves only when the importer holds the required import permit and the exporter the matching export authorisation. Ask for a CTD or ACTD dossier for the exact delivery form, with spray performance data for the nasal device. Syringes sit in protective tubes and sprays in sealed blisters, at room temperature. Collect a CoA per batch, GMP certificate and CoPP. State nasal or buccal, strengths by age band, carton language and shelf life on arrival.

Midazolam Nasal Spray — third party manufacturing & bulk supply

Midazolam Nasal Spray 2.5 mg, 5 mg, 7.5 mg, 10 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

Midazolam Nasal Spray is supplied as Nasal/Buccal — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. 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 Midazolam Nasal Spray 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

Midazolam nasal spray is used for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity, also known as seizure clusters or acute repetitive seizures, in patients with epilepsy. It is designed for rapid administration through the nose to quickly control seizures outside of a hospital setting.

Midazolam nasal spray is made from the active pharmaceutical ingredient midazolam hydrochloride. It belongs to the benzodiazepine class of medicines and works by enhancing the effect of gamma-aminobutyric acid (GABA), a neurotransmitter that helps calm excessive electrical activity in the brain.

The main trade name in the United States is Nayzilam. In Europe and the United Kingdom, midazolam is commonly available as Buccolam in an oromucosal (buccal) formulation.

Nayzilam is marketed by UCB Inc. Buccolam is marketed by Neuraxpharm in several European countries.

The generic name is midazolam hydrochloride.

The brand name in the USA is Nayzilam. In Europe and the UK, it is available as Buccolam (buccal formulation).

Midazolam nasal spray products are manufactured in GMP-certified pharmaceutical facilities in the United States and Europe, depending on the brand owner and marketing authorization holder. Specific manufacturing locations may vary by region and batch.