Diclofenac Tablets

Analgesic, Anti-Inflammatory & Anti-Pyretic · Gastro-Resistant Tablets · 50mg

Trade Information

Minimum Order Qty	10,000 tablets
Capacity	100 Million Tablets per month
Strength	50mg
Private Labelling	Custom branding, artwork & market-specific labelling
Lead Time	45–60 days from order confirmation
Payment Terms	LC at sight, TT (advance / against documents)
Shipping	FOB / CIF to major international ports including Mombasa, Dar es Salaam, Lagos, Durban, Manila, Phnom Penh
Pharmacopoeia	BP, USP, IP compliant

Packing Options

Blister (Alu-Alu / Alu-PVC)
Strip pack
Bottle pack (HDPE)
Hospital bulk pack
Custom packing as per buyer requirement

Regulatory & Quality

Registration Status	Registered in multiple African, Asian, and CIS markets. Dossier available for new market registration.
Regulatory Dossiers	CTD / ACTD format dossiers available for submission to national drug authorities.
Stability Data	Zone IVa & IVb stability data available (tropical climate conditions, 30°C/65% RH & 30°C/75% RH)
WHO Prequalification	WHO-GMP Certified

Product Details

Composition	Diclofenac Sodium
Dosage Form	Gastro-Resistant Tablets
Pack Size	10x10 / Custom packing available
Storage	Store below 30°C in a dry place, protected from light
Shelf Life	24 months from date of manufacture

Description

Diclofenac Sodium is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain, inflammation, and swelling. It works by blocking the production of prostaglandins, substances that cause pain and inflammation in the body.

BioGalen manufactures Diclofenac Tablets in gastro-resistant formulation to minimise GI side effects, ensuring better patient compliance and therapeutic outcomes.

Mechanism of Action

Diclofenac Sodium works by non-selectively inhibiting both cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes. This blocks the conversion of arachidonic acid to prostaglandins — lipid compounds that mediate pain, inflammation, and fever at the site of tissue injury. By reducing prostaglandin synthesis, Diclofenac provides potent analgesic, anti-inflammatory, and antipyretic effects. It also inhibits the lipoxygenase pathway and reduces thromboxane-prostanoid receptor sensitivity, contributing to its superior anti-inflammatory potency compared to many other NSAIDs. The gastro-resistant formulation ensures the tablet dissolves in the intestine rather than the stomach, reducing direct gastric mucosal irritation.

Indications

Rheumatoid arthritis
Osteoarthritis
Ankylosing spondylitis
Acute musculoskeletal disorders
Post-operative pain and inflammation
Dental and minor surgical pain

Available Variants

Diclofenac Tablets 50mg (Gastro-Resistant)
Diclofenac Prolonged-Release Tablets 100mg
Diclofenac Prolonged-Release Capsules 100mg
Diclofenac Sodium 50mg & Paracetamol 325mg Tablets
Diclofenac Sodium 50mg & Paracetamol 500mg Tablets
Diclofenac Sodium 50mg, Paracetamol 325mg & Chlorzoxazone 250mg Tablets
Diclofenac Sodium 50mg, Paracetamol 500mg & Chlorzoxazone 250mg Tablets

Frequently Asked Questions

Why choose gastro-resistant Diclofenac over standard tablets?

Gastro-resistant (enteric-coated) Diclofenac tablets are designed to pass through the stomach intact and dissolve in the alkaline environment of the small intestine. This significantly reduces the risk of gastric irritation and ulceration — a key concern for patients on long-term NSAID therapy. For B2B buyers, gastro-resistant formulations command higher margins and are preferred in hospital formularies and government tenders.

What combination products are available with Diclofenac?

BioGalen manufactures several Diclofenac combinations including Diclofenac + Paracetamol (325mg/500mg) and Diclofenac + Paracetamol + Chlorzoxazone (muscle relaxant). These fixed-dose combinations are widely prescribed in Africa and Asia for musculoskeletal pain and are available for private labelling with custom branding.

What is the shelf life and storage requirement for bulk shipments?

BioGalen Diclofenac Tablets have a 24-month shelf life from the date of manufacture. They should be stored below 30°C in a dry place, protected from light. Our stability data covers Zone IVa and IVb conditions (tropical climates), ensuring product integrity throughout the supply chain in hot and humid markets.

Can Diclofenac Tablets be supplied under our own brand name?

Yes. BioGalen provides full private labelling and contract manufacturing services for Diclofenac Tablets. We handle custom artwork, market-specific packaging, and provide all regulatory documentation (CTD/ACTD dossiers) needed for brand registration in your target market.

Interested in Diclofenac Tablets?

Get competitive pricing for bulk orders, private labelling, and contract manufacturing.

WhatsApp Enquiry Contact Us

Browse Categories

Browse by Dosage Form