Pirenzepine Tablets 25 mg, 50 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 25 mg, 50 mg

Reference Brands: Gastrozepin

Pirenzepine tablets (25 mg, 50 mg) are an M1-selective antimuscarinic medicine that reduces stomach acid, used for peptic ulcer and gastritis in the countries where it is still registered. The reference brand is Gastrozepin. It is not approved in the US, and few manufacturers still make it. Ask PharmaTradz for a quote; we confirm the manufacturer, registration documents and lead time for your country.

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Product Description:

Pirenzepine blocks M1 muscarinic receptors, the receptors on nerve cells in the stomach wall that switch on acid secretion. Older antimuscarinic medicines such as atropine block all muscarinic receptors and cause dry mouth, blurred vision and a fast heart rate at doses that reduce acid. Pirenzepine is selective for the M1 type and does not cross into the brain, so at usual doses it lowers acid with fewer of those effects.

It is used for duodenal and gastric ulcers and for gastritis, taken two or three times a day before meals. In most countries it has been replaced by proton pump inhibitors and H2 blockers, which reduce acid more strongly, but it is still prescribed in some markets, including Japan, where 25 mg tablets are sold. Dry mouth and constipation are the most common side effects.

Sourcing notes. Pirenzepine is an older, low-volume product with few remaining manufacturers, so supply and document status vary and we confirm current sources before quoting. Low-dose pirenzepine eye gel was studied in children to slow the progression of short-sightedness (myopia), but it was never approved; current myopia research focuses on low-dose atropine eye drops. Any eye use would need its own registration. Finished product, API and dossier enquiries are welcome.

Pirenzepine Tablets — third party manufacturing & bulk supply

Pirenzepine Tablets 25 mg, 50 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

Pirenzepine Tablets is supplied as Tablets — 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 Pirenzepine Tablets 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

Peptic ulcer and gastritis. It reduces stomach acid by blocking M1 muscarinic receptors in the stomach wall.

Gastrozepin, the original brand from Boehringer Ingelheim. Generic pirenzepine tablets are sold in a few markets, including Japan.

Low-dose pirenzepine eye gel was tested in children to slow myopia, but it was not approved. Low-dose atropine eye drops are the option studied most today.

No. It has never been approved by the US FDA. It is registered in some other countries, so we confirm the position for your market before quoting.