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Lactose Monohydrate bulk supplier for pharma manufacturers

Lactose Monohydrate 20% to 90% Suppliers & Bulk Manufacturers

Available Forms: Crystalline powder

Available Strengths: 20% to 90%

Reference Brands: Pharmatose (USA/EU), Lactochem (EU/UK)

Category: Pharmaceutical Excipients

Lactose Monohydrate is a Pharmaceutical Excipients product available as Crystalline powder in strengths 20% to 90%. It corresponds to the reference brands Pharmatose (USA/EU), Lactochem (EU/UK). 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:

Lactose monohydrate is a naturally occurring sugar derived from milk and widely used as a pharmaceutical excipient, particularly as a filler, diluent, and stabilizer in tablets, capsules, and oral powders. Chemically, it is a disaccharide composed of glucose and galactose, with one molecule of water of crystallization per lactose molecule, giving it a crystalline, white appearance. Its excellent compressibility, flow properties, and compatibility with a wide range of active pharmaceutical ingredients make it a preferred choice in oral solid dosage forms.

In addition to pharmaceuticals, lactose is extensively used in the food industry, where it provides bulk, sweetness, and stability to various formulations. However, growing awareness of lactose intolerance has led to increased demand for lactose-free alternatives, prompting careful formulation and labeling considerations to accommodate consumers with lactose sensitivity.

Lactose monohydrate is safe, biocompatible, and generally well-tolerated, although individuals with lactose intolerance may need to avoid products containing it. Its versatility allows it to improve tablet hardness, ensure uniform mixing, and aid in controlled-release formulations, making it a key excipient in both pharmaceutical and nutraceutical product development. By offering consistent performance, lactose monohydrate continues to support high-quality formulation across a broad range of applications.

Lactose Monohydrate — third party manufacturing & bulk supply

Lactose Monohydrate 20% to 90% 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 Lactose Monohydrate 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

Lactose monohydrate is used as a filler or diluent in pharmaceutical tablets and capsules. It provides bulk to the formulation, aids in tablet compression, and ensures uniform distribution of the active pharmaceutical ingredient. It also helps improve powder flow, stability, and compressibility.

Lactose monohydrate is derived from purified milk sugar (lactose) and contains one molecule of water of crystallization per molecule of lactose.

Common trade names include Pharmatose®, Lactochem®, Lactohale®, and SuperTab®.

Lactose monohydrate is manufactured by companies such as DFE Pharma, Tate & Lyle, Meggle, and BASF.

The generic name is Lactose Monohydrate.

Brand names include Pharmatose®, Lactochem®, Lactohale®, and SuperTab®.

Lactose monohydrate is manufactured in pharmaceutical excipient production facilities across Germany, the United Kingdom, the United States, India, and China.

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