Arimoclomol bulk supplier for pharma manufacturers

Arimoclomol Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 47 mg, 62mg, 93mg

Reference Brands: MIPLYFFA (USA)

Category: Orphan Drugs

Arimoclomol (brand name Miplyffa) is an orphan drug used for treating the neurological manifestations of Niemann-Pick disease type C (NPC) in patients aged 2 years and older. It works by enhancing heat-shock protein production, helping protect cells from stress and improving protein handling. Arimoclomol is available as oral capsules in multiple strengths and is used together with miglustat to slow neurological progression in NPC. Arimoclomol is available in Capsules and strengths such as 47 mg, 62mg, 93mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Arimoclomol is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Arimoclomol can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

Arimoclomol is a prescription medication indicated for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) when used in combination with miglustat in adults and pediatric patients aged 2 years and older. NPC is a rare, progressive genetic lysosomal storage disorder characterized by impaired lipid trafficking in cells, which leads to lipid accumulation in the brain and other organs, resulting in severe neurological and systemic symptoms. Arimoclomol works by enhancing the cellular heat shock response—boosting production of protective heat shock proteins (HSPs) that help maintain normal protein folding and assist in cellular stress management. It is orally administered in capsule form in weight-based doses, usually taken three times a day, and may be swallowed whole or opened and mixed with liquid or soft foods for patients with swallowing difficulties. Arimoclomol is notable for its ability to cross the blood–brain barrier, a critical feature for therapies targeting neurodegenerative processes. Common side effects include upper respiratory tract infection, diarrhea, and decreased weight. Arimoclomol was approved by the U.S. Food and Drug Administration in 2024 and represents a first-in-class treatment for NPC.

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Frequently Asked Questions

Arimoclomol is used for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC). It is given in combination with miglustat to help slow the progression of neurological symptoms in both adults and children aged 2 years and older.

Arimoclomol is made from the active pharmaceutical ingredient arimoclomol citrate, a small-molecule heat shock protein co-inducer that helps promote proper protein folding and supports cellular stress response mechanisms.

The trade name of arimoclomol is Miplyffa.

Arimoclomol (Miplyffa) is manufactured and marketed by Zevra Therapeutics in the United States.

The generic name is arimoclomol citrate.

The brand name is Miplyffa.

Arimoclomol (Miplyffa) is manufactured in the United States.

Yes, Arimoclomol is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Arimoclomol is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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