BioGalen Pharmaceuticals

Dipyrone (Metamizole) Tablets

Analgesic, Anti-Inflammatory & Anti-Pyretic · Tablets / Injection · 500mg (tablets), 500mg/ml (injection)

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Trade Information

Minimum Order Qty 1,000,000 tablets
Capacity 100 Million Tablets per month
Strength 500mg (tablets), 500mg/ml (injection)
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, IP compliant

Packing Options

  • Blister (Alu-Alu / Alu-PVC)
  • Strip pack
  • Ampoule (injection)
  • Hospital bulk pack
  • Custom packing as per buyer requirement

Regulatory & Quality

Registration Status Registered and widely used in many African, Latin American, and Asian markets. Restricted or not marketed in certain other countries. Supplied only to markets where registered and approved. 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 Metamizole Sodium (Dipyrone)
Dosage Form Tablets / Injection
Pack Size 10x10 (tablets), ampoule (injection) / Custom packing available
Storage Store below 30°C in a dry place, protected from light
Shelf Life 24 months from date of manufacture

Description

Dipyrone (metamizole) is a potent pyrazolone analgesic and antipyretic widely used for moderate to severe pain and high fever in the many markets where it is registered. It has strong analgesic and antipyretic effects with some spasmolytic activity.

BioGalen manufactures Dipyrone in tablet and injection forms and supplies it only to markets where it is registered and approved for use, with CTD and ACTD dossiers and regulatory support for registration in those markets. Please confirm the regulatory status in your market when enquiring.

Mechanism of Action

Dipyrone (metamizole) is a pyrazolone-class agent. Its active metabolites are thought to inhibit prostaglandin synthesis and to act on central pain and temperature pathways, producing strong analgesic and antipyretic effects together with some spasmolytic (smooth-muscle relaxing) activity. Unlike the NSAIDs, it has only weak anti-inflammatory action, and its potency makes it useful for moderate to severe pain and high fever in the markets where it is registered.

Indications

  • Moderate to severe pain
  • Post-operative pain
  • Colicky (smooth-muscle spasm) pain
  • High fever not responding to other agents

Available Variants

  • Dipyrone (Metamizole) Tablets 500mg
  • Dipyrone (Metamizole) Injection

Frequently Asked Questions

What is Dipyrone (Metamizole) used for?
Dipyrone is a potent pyrazolone analgesic and antipyretic used for moderate to severe pain, including post-operative and colicky pain, and for high fever. It is widely used in many markets where it is registered.
Is Dipyrone available in all countries?
Dipyrone is registered and widely used in many African, Latin American, and Asian markets, but is restricted or not marketed in some others. BioGalen supplies Dipyrone only to markets where it is registered and approved for use.
What forms of Dipyrone does BioGalen manufacture?
BioGalen manufactures Dipyrone (metamizole) in tablet and injection forms, under WHO-GMP with CTD and ACTD dossiers available for registration where applicable.

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