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Diclofenac Sodium
API

Diclofenac Sodium grades are available to suit a wide range of formulations requiring precise control over the release rate

HUMAN API

Diclofenac Sodium API

Diclofenac Sodium is a vital Active Pharmaceutical Ingredient (API) belonging to the Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) class. It is characterized by its powerful triple action: Analgesic (pain relief), Anti-inflammatory, and Antipyretic (fever reduction). Diclofenac Sodium is a key choice for immediate-release, extended-release, and topical formulations, with high demand for managing various pain and inflammatory conditions.

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).
Therapeutic Class:
Non-Steroidal Anti-Inflammatory Drug (NSAID).
Mechanism of Action:
Inhibits Cyclooxygenase enzymes (COX-1 and COX-2), which reduces the biosynthesis of prostaglandins responsible for pain and inflammation throughout the body.
Clinical Application:
Management of pain and inflammation in conditions such as arthritis, gout, post-operative pain, dysmenorrhea (menstrual pain), and musculoskeletal disorders..
Competitive Advantage:
High Potency and established clinical efficacy, with the Sodium salt form offering good solubility for rapid absorption.
Tablets and Capsules

Immediate-release, extended-release, and enteric-coated tablets.

Supplied in grades with enhanced flow and compressibility characteristics for high-speed tableting, recognizing the need for Enteric Coating for gastric protection.

Topical Formulations

Gels, creams, and topical solutions for localized pain relief.

Good solubility and dispersibility in dermal bases for producing highly effective topical products.

Injections and Suppositories

Intramuscular (IM) injection solutions and rectal suppositories.

Availability of high-purity grades meeting sterility requirements (for injectables) and stability in fatty bases (for suppositories).

Regulatory Compliance

The product conforms to the specified requirements of the United States Pharmacopeia (USP), European Pharmacopoeia (EP), and/or British Pharmacopoeia (BP).

Certificate of Analysis (CoA)

A detailed CoA is issued with every batch, outlining potency, purity profile, and microbiological testing verification.

Drug Master File (DMF)

A comprehensive Drug Master File is available to support registration submissions to regulatory authorities worldwide.

Manufacturing Operations

Production takes place in certified facilities that strictly adhere to current Good Manufacturing Practices (cGMP).

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