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Lactose Monohydrate bulk supplier for pharma manufacturers

Lactose Monohydrate 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 available in Crystalline powder and strengths such as 20% to 90%. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Lactose Monohydrate is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Lactose Monohydrate can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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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.

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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.

Yes, Lactose Monohydrate is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Lactose Monohydrate is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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