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Naldemedine bulk supplier for pharma manufacturers

Naldemedine Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 0.2 mg

Reference Brands: Symproic (USA/EU)

Category: Gastrointestinal Drugs

Naldemedine is available in Tablets and strengths such as 0.2 mg. 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, Naldemedine 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)

Naldemedine 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:

Naldemedine is a peripherally acting μ-opioid receptor antagonist used for the treatment of opioid-induced constipation in adults. It is specifically indicated in the United States for patients with chronic non-cancer pain, including pain related to prior cancer or its treatment, and in the European Union for adults who have previously used a laxative for opioid-induced constipation. Naldemedine works by blocking opioid receptors in the gastrointestinal tract, which helps restore normal bowel function without interfering with the central pain-relieving effects of opioids.

The medication has been shown in clinical studies to be effective in increasing bowel movement frequency and improving related symptoms, with most side effects being mild to moderate and primarily gastrointestinal in nature. Central opioid withdrawal symptoms or effects on analgesia are rare. Naldemedine is marketed under the brand name Symproic in the US and Rizmoic in the EU, and was developed by Shionogi. Its targeted mechanism of action allows patients to maintain opioid pain therapy while effectively managing constipation, improving overall comfort and quality of life.

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Frequently Asked Questions

Naldemedine is used for the treatment of opioid-induced constipation in adults with chronic non-cancer pain.

It is a synthetic peripherally acting mu-opioid receptor antagonist formulated as naldemedine tosylate for oral use.

The trade name is Symproic.

It is marketed by Shionogi (and partners such as Purdue in some regions).

The generic name is naldemedine tosylate.

The brand name is Symproic.

It is manufactured in GMP-approved pharmaceutical facilities by licensed manufacturers for the marketing authorization holders.

Yes, Naldemedine 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, Naldemedine 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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