Pan Am Farma

Sorafenib 200mg Tab

Product Overview
Generic NameSorafenib 200mg Tab
Brand Name(s)Nexavar
FormOral film-coated tablets
Strength200 mg
Therapeutic ClassMultikinase inhibitor (VEGFR/RAF/PDGFR) antineoplastic agent
ATC CodeL01EX02
Manufacturing & Regulatory
ManufacturerBayer
CountryIndia/USA/EU
GMP ComplianceFDA/EMA/WHO-GMP
DMF/CEPType II
COFEPRISBatch-specific
Free Sale CertificateYes
Logistics & Export
MOQ100 units
Shelf Life24 months
Storage20-25 °C (15-30 °C allowed)
IncotermsEx-Works Mexico
Lead Time7 to 10 Days
Documentation
Certificate of Analysis (COA)Yes
SDSUpon Request, not publicly posted
CTD SummaryCTD available to regulators; summary available to qualified partners

Description

Indications & Use: - Hepatocellular Carcinoma (HCC): First-line treatment for unresectable HCC in adult patients. - Renal Cell Carcinoma (RCC): Advanced RCC after failure of prior interferon-alpha or IL-2-based therapy. - Differentiated Thyroid Carcinoma (DTC): Locally recurrent or metastatic, progressive, radioactive iodine-refractory DTC (papillary, follicular, or Hürthle cell carcinoma)

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