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Naldemedine bulk supplier for pharma manufacturers

Naldemedine 0.2 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 0.2 mg

Reference Brands: Symproic (USA/EU)

Category: Gastrointestinal Drugs

Naldemedine is a Gastrointestinal Drugs product available as Tablets in strengths 0.2 mg. It corresponds to the reference brand Symproic (USA/EU). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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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.

Naldemedine — third party manufacturing & bulk supply

Naldemedine 0.2 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.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Naldemedine listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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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.

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