Itopride Hydrochloride bulk supplier for pharma manufacturers

Itopride Hydrochloride 50mg Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: 50mg

Reference Brands: Progit (EU), Itoprid (UK)

Itopride Hydrochloride is a gastroprokinetic agent used to treat functional dyspepsia and other gastrointestinal motility disorders. It works by enhancing gastric emptying and improving gastrointestinal motility through dopamine D2 receptor antagonism and acetylcholinesterase inhibition.

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Product Description:

Itopride is a gastroprokinetic with a dual mechanism. It is a dopamine D2 antagonist, which removes dopamine's inhibitory brake on gut motility, and an acetylcholinesterase inhibitor, which raises acetylcholine at the myenteric plexus. Together these increase gastric antral contractions and speed gastric emptying. It does not cross the blood-brain barrier well, which lowers the risk of extrapyramidal effects seen with metoclopramide.

It is used for functional dyspepsia — early satiety, postprandial fullness, bloating and upper abdominal discomfort — at 50 mg three times daily before meals. Trials in Asia supported benefit, but a large multinational phase III programme gave mixed results. Adverse effects are generally mild: diarrhoea, abdominal pain, headache and, occasionally, raised prolactin with galactorrhoea or gynaecomastia. Unlike cisapride, it is metabolised mainly by flavin monooxygenase rather than CYP3A4, and has not been associated with QT prolongation.

Sourcing notes. Itopride originated in Japan and is registered widely across Asia, Russia and CIS countries, and parts of the Middle East and Latin America, but it is not authorised in the US or through the EU. Generic supply is plentiful in its registered markets. Registration in the destination market is therefore the first question.

Itopride Hydrochloride — third party manufacturing & bulk supply

Itopride Hydrochloride 50mg 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

Itopride Hydrochloride is supplied as Tablet — 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 Itopride Hydrochloride 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

Itopride Hydrochloride is listed as Tablet in 50mg. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Itopride Hydrochloride is referenced against Progit (EU), Itoprid (UK). Reference brands are shown for identification only and remain the property of their respective trademark owners.