Pan Am Farma

Etanercept 25mg Vial

Product Overview
Generic NameEtanercept 25mg Vial
Brand Name(s)Enbrel (originator); biosimilars: Benepali, Brenzys, Erelzi
FormVial, Solution for subcutaneous injection
Strength25 mg
Therapeutic ClassAnti‑tumor necrosis factor agent for autoimmune disorders
ATC CodeL04AB01
Manufacturing & Regulatory
ManufacturerAmgen; outside US/Pfizer; Biosimilar manufacturers
CountryIndia/USA/EU
GMP ComplianceWHO-GMP
DMF/CEPManufacturer-specific, not public
COFEPRISUnder Registration (2025)
Free Sale CertificateAvailable per batch upon request
Logistics & Export
MOQ10 Units
Shelf Life24 Months
Storage2–8 °C, protect from light
IncotermsEXW/FOB/CIF negotiable
Lead Time7 - 10 Business Days
Documentation
Certificate of Analysis (COA)Supplied per batch upon request
SDSUpon Request, not publicly posted
CTD SummaryFull CTD dossier proprietary; available under commercial agreement/license

Description

Indications & Usage: Etanercept is indicated for moderate to severe rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and moderate to severe plaque psoriasis. Mechanism: a TNF‑alpha decoy receptor fusion protein that binds & neutralizes soluble TNF
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