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Lactose

To guarantee the highest purity and efficacy, we adhere to strict global standards

Pharmaceutical Excipients

Lactose

Lactose is a traditional and fundamental pharmaceutical excipient, a natural disaccharide derived from milk. It is the most widely used Diluent (Filler) in the manufacture of tablets and capsules. We supply Lactose in its different forms (such as Monohydrate and Spray-Dried Lactose) in ultra-high pharmaceutical grades, making it ideal for enhancing powder flow and compressibility in both wet granulation and direct compression processes.

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).
A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.
A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.
Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).
Functional Class:
Diluent (Filler), Binder, Carrier.
Chemical Formula:
(Lactose Monohydrate).
Mechanism of Action:
Provides bulk to the Active Pharmaceutical Ingredient (API) to ensure accurate dosing, and significantly improves the compressibility and cohesion in tablets.
Optimal Use:
Used as the base for most solid dosage formulations, especially in low-dose formulations where the API amount is very small.
Lactose Monohydrate

Wet Granulation, Capsule Filling.

Economical, chemically stable, and suitable for traditional granulation processes.

Spray-Dried Lactose

Direct Compression.

Characterized by excellent flowability and high compressibility, minimizing the need for other excipients.

Anhydrous Lactose

Moisture-Sensitive Formulations.

Has a very low moisture content, protecting water-sensitive Active Pharmaceutical Ingredients (APIs).

Regulatory Compliance

The product fully complies with the requirements specified in the United States Pharmacopeia (USP), the European Pharmacopoeia (EP), and/or other relevant standards.

Particle Size Distribution (PSD))

Strict control over the Particle Size Distribution (PSD) is maintained to ensure consistent performance in granulation and direct compression processes.

Purity and Impurity Control

Strict control over moisture content and undesirable impurities, with certification for $\text{Non-GMO}$ status.

Manufacturing Operations

Production is conducted in a rigorous cGMP environment, ensuring consistency in physical properties.

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