Pan Am Farma

Repotrectinib 40mg Cap

Product Overview
Generic NameRepotrectinib 40mg Cap
Brand Name(s)Augtyro™
FormHard shell capsules; oral use
Strength40 mg; 160 mg
Therapeutic ClassAntineoplastic agent; kinase inhibitor
ATC CodeL01EX28
Manufacturing & Regulatory
ManufacturerBristol-Myers Squibb
CountryUSA, UK
GMP ComplianceWHO-GMP, EU-GMP
COFEPRISNo confirmed COFEPRIS clave found
Free Sale Certificateonly through BMS or an authorised distributor
Logistics & Export
MOQ10 Units
Shelf Life12-18 Months
Storagestore below 25°C
IncotermsEx-Works Mexico
Lead Time7 - 10 Business Days
Documentation
Certificate of Analysis (COA)batch-specific CoA / Certificate of Conformance / batch release documentation from BMS
CTD SummaryFull CTD/eCTD Modules 2–5 remain proprietary and are not provided freely

Description

An oral kinase inhibitor indicated for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer

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