1 INDICATIONS AND USAGE
Edaravone Injection is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
2 DOSAGE AND ADMINISTRATION
2.1 Dosage Information
The recommended dosage of Edaravone Injection is an intravenous infusion of 60 mg administered over a 60-minute period according to the following schedule:
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An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug-free period
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Subsequent treatment cycles with daily dosing for 10 days out of 14-day periods, followed by 14-day drug-free periods.
2.2 Preparation and Administration Information
Edaravone Injection is for intravenous infusion only.
3 DOSAGE FORMS AND STRENGTHS
Edaravone Injection is supplied for intravenous infusioncontaining 30 mg of edaravone in 20 mL of clear, colorless aqueous solution.
Our factory
This product is produced in our GMP factory, all our facility has past China GMP, and also officially certificated by more than ten countries' MOH.
Our Service
We can specially develop the products per customers' specification.
We can offer OEM service with customers' private brands and labels.
We can offer excellent after-sale service and professional technical support.
Our Quality control system
In manufacturing, quality is what sustains our life. Starting from the material selection, there are many factors that contribute to the quality control process. Our manufacturing facility is GMP certified. Quality Control (QC) and monitoring procedures are built into every aspect of our work.
Our Quality Control System is outlined below:
Initial inspection (such as raw material, excipients, package materials, etc.)
In-process inspection (make sure that each testing items should be qualified )
Final inspection before shipment of each order.
Provide temperature control recorder when it is necessary for special market before loading.
Our Registration Team and technical support
We have experienced team to provide qualified and professional registration documents for most of countries. Up to present, we have registered more than hundred products and exported to more than 20 countries. Especially including those in Asia, Africa, South America, Middle east area and East Europe.
We can provide regulatory documents
GMP Certificate / CE Certificate
Free sales certificate
Certificate of Pharmaceutical Products
Manufacture License
CTD Dossier.