Fentanyl Injectable Suppliers & Bulk Manufacturers
Available Forms: Injectable (IV, IM, SC)
Available Strengths: 50 mcg/mL, 100 mcg/mL, 200 mcg/mL
Reference Brands: Durogesic(US & EU)
Category: Analgesic
Fentanyl injection activates mu-opioid receptors in the brain and spinal cord, blocking pain signals and altering pain perception. It provides rapid, potent relief from severe pain, especially during anesthesia or acute pain management. Benefits include quick onset, reliable analgesia, and effective pain control in critical care settings. Fentanyl Injectable is available in Injectable (IV, IM, SC) and strengths such as 50 mcg/mL, 100 mcg/mL, 200 mcg/mL. 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, Fentanyl Injectable 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) |
Fentanyl Injectable 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.
Product Description:
Fentanyl injection is approved in the EU and US for anesthesia induction, pain management, and as part of anesthesia protocols. In the EU, brands like Durogesic are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data, biosimilarity, and pharmacovigilance. Both regions require detailed dossiers for initial approval and continuous safety monitoring. Due to high abuse potential, strict control measures are enforced. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate seamless market access for fentanyl injection products while ensuring adherence to European and US standards for safe, effective opioid therapy.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Fentanyl is used for the management of severe pain, especially during surgical procedures or in situations where strong, fast-acting pain relief is required. It works as a potent synthetic opioid that acts quickly on the central nervous system.
Fentanyl is made from fentanyl citrate, a fully synthetic opioid created through chemical synthesis, designed to provide strong analgesic effects at very small doses.
Common trade names include Sublimaze and Fentanil.
Sublimaze has been marketed by Janssen Pharmaceuticals, while many global pharmaceutical companies manufacture generic fentanyl.
The generic name is fentanyl citrate.
The well-known brand names include Durogesic, Sublimaze and Fentanil.
Fentanyl is manufactured in multiple countries including India, the USA, and various EU regions by several branded and generic pharmaceutical manufacturers.
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