Metformin Crystals/Powder bulk supplier for pharma manufacturers

Metformin Crystals/Powder Suppliers & Bulk Manufacturers

Available Forms: Crystals/Powder

Available Strengths: Supplied as high-purity crystals in 99%

Reference Brands: -

Category: Active Pharmaceutical Ingredient

Metformin hydrochloride API, white crystalline powder to pharmacopoeial grade, for manufacturers of metformin tablets, extended-release forms and combinations. For formulators and API buyers needing DMF or CEP support.

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Product Description:

This page is for metformin hydrochloride API, a white crystalline powder for finished-dose manufacturers. Metformin is a biguanide that lowers blood glucose mainly by cutting liver glucose output and improving insulin response. The API is freely soluble in water and has monographs in the European, British and United States pharmacopoeias. Test against the monograph in your dossier rather than a bare figure such as 99%; it sets the assay range, related substances and loss on drying, with elemental impurities assessed under ICH Q3D.

Metformin is first-line oral therapy for type 2 diabetes and is on the WHO Model List of Essential Medicines. The API goes into immediate- and extended-release tablets, oral solutions and fixed-dose combinations. Doses are high and the powder compresses poorly, so particle size matters: fine powder suits wet granulation, a direct-compression grade simplifies tableting. Impurity control covers cyanoguanidine and other related substances. Since NDMA was found in some finished metformin products, regulators expect a documented nitrosamine risk assessment, with confirmatory testing.

Sourcing notes. Ask for the US Type II Drug Master File number with a letter of access, a CEP for European filings, or an ASMF. For EU products, written confirmation for imported active substances is needed where applicable. CE marking does not apply to an API. Ask for the GMP certificate, a CoA per batch, the retest period and stability data, including Zone IVb where relevant. Packing is usually double polyethylene bags in drums, kept dry at room temperature. State pharmacopoeia, particle size grade and annual quantity in your enquiry.

Metformin Crystals/Powder — third party manufacturing & bulk supply

Metformin Crystals/Powder 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 Crystals/Powder is supplied as Crystals/Powder — a dosage form priced by order value, so the indicative MOQ is a minimum order value of USD 5,000 per product. 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 Crystals/Powder 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

Metformin Crystals or Powder are used as an active pharmaceutical ingredient in the manufacturing of antidiabetic medicines. It is primarily formulated into tablets or capsules to help control high blood sugar levels in patients with type 2 diabetes mellitus.

Metformin Crystals/Powder contain the active compound metformin hydrochloride, a biguanide derivative. It lowers blood glucose levels by decreasing hepatic glucose production and improving insulin sensitivity.

The generic name is metformin hydrochloride.

Metformin Crystals/Powder are produced by various API manufacturers in India, China, and Europe under WHO-GMP and other international regulatory standards for pharmaceutical bulk production.