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Metformin  Hcl IR tablets bulk supplier for pharma manufacturers

Metformin Hcl IR Tablets 500 mg, 850 mg, 1000 mg Suppliers & Bulk Manufacturers

Available Forms: IR Tablets

Available Strengths: 500 mg, 850 mg, 1000 mg

Reference Brands: Glucophage® (US & EU)

Category: Diabetes

Metformin IR reduces hepatic glucose production and improves insulin sensitivity by activating AMP-activated protein kinase (AMPK). It does not stimulate insulin secretion, reducing the risk of hypoglycemia. Benefits include effective blood glucose control, weight neutrality, and cardiovascular protection, making it a first-line therapy for type 2 diabetes management.

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Product Description:

Metformin hydrochloride has long been the usual first-line medicine for type 2 diabetes and is on the WHO Model List of Essential Medicines. It lowers blood glucose mainly by reducing glucose production in the liver and rarely causes hypoglycaemia on its own. Immediate-release tablets come in 500, 850 and 1000 mg and are taken with meals; extended-release tablets allow once-daily dosing with fewer stomach side effects. The originator brand is Glucophage.

Who makes metformin?

Metformin is long off patent and is one of the most widely prescribed medicines in the world. Metformin hydrochloride API is made in large quantities in India and China, and Indian companies are major suppliers of metformin tablets to the US and other regulated markets as well as to India's own market.

NDMA testing

In 2020 the US FDA asked several manufacturers to recall extended-release metformin after finding the nitrosamine impurity NDMA above the acceptable intake limit. Buyers now expect a nitrosamine risk assessment and NDMA results for both the API and the finished product.

What to check when you buy

  • Form and strength: immediate- or extended-release, and the strengths registered in your market. Our explainer on immediate and extended release covers the difference.
  • Certificate of Analysis to the USP, Ph. Eur. or IP monograph, with NDMA results.
  • Documents: a DMF or CEP for the API where your market requires one, bioequivalence data for the tablets, and the site's GMP certificate.

We also list metformin extended-release tablets, metformin oral solution and metformin API, and combinations such as glimepiride with metformin, vildagliptin with metformin, sitagliptin with metformin, dapagliflozin with metformin and empagliflozin with metformin. Send us an RFQ with the form, strength, quantity and market.

Also known as: metformina (Spanish), metformine (French), метформин (Russian), ميتفورمين (Arabic), 二甲双胍 (Chinese), メトホルミン (Japanese), 메트포르민 (Korean), เมตฟอร์มิน (Thai).

Metformin Hcl IR Tablets — third party manufacturing & bulk supply

Metformin Hcl IR Tablets 500 mg, 850 mg, 1000 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

Metformin Hcl IR Tablets is supplied as IR 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 Metformin Hcl IR Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

Request a quote for Metformin Hcl IR Tablets →

Usually answered within 48 hours, with matched manufacturers, indicative prices and document status.

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Frequently Asked Questions

Metformin is off patent and is made by many manufacturers worldwide. Much of the world's metformin API is made in India and China, and Indian companies supply a large share of metformin tablets to the US and other markets. We match each enquiry with manufacturers whose documents fit your market.

Much of it is made in India and China, with further production in Europe, the US and elsewhere. The country of manufacture of a specific product is shown in its registration and labelling.

Immediate-release tablets of 500, 850 and 1000 mg; extended-release tablets of 500, 750 and 1000 mg; and an oral solution of 500 mg/5 mL.

Because some extended-release metformin was recalled in the US in 2020 for NDMA above the acceptable limit. A nitrosamine risk assessment and NDMA results are now standard requests.

Immediate-release tablets are taken two or three times a day with meals; extended-release tablets release the drug slowly, are usually taken once daily with the evening meal and cause fewer stomach side effects.

La metformina es un antidiabético oral del grupo de las biguanidas indicado para la diabetes mellitus tipo 2, junto con dieta y ejercicio, sola o combinada con otros antidiabéticos o con insulina. Se usa con receta y bajo supervisión médica. En PharmaTradz, los importadores, distribuidores y hospitales autorizados pueden contactar con fabricantes que cumplen las normas GMP.

A metformina é um antidiabético oral da classe das biguanidas indicado para o diabetes mellitus tipo 2, associado a dieta e exercício, isoladamente ou em combinação com outros antidiabéticos ou com insulina. É usada com prescrição e sob supervisão médica. Importadores, distribuidores e hospitais licenciados podem solicitar cotações a fabricantes certificados GMP na PharmaTradz.

La metformine est un antidiabétique oral de la famille des biguanides indiqué dans le diabète de type 2, en complément du régime alimentaire et de l'exercice physique, seule ou associée à d'autres antidiabétiques ou à l'insuline. Elle est délivrée sur ordonnance et s'utilise sous surveillance médicale. Sur PharmaTradz, distributeurs, importateurs et hôpitaux agréés sont mis en relation directe avec des fabricants certifiés GMP.

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