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Oncology GMP Certificate High Quality OEM Bortezomib for Injection 3.5mg
US$0.10
30,000 Pieces
Sample price:US$0.10/piece.Request sample
Product profile
Customization
AvailableDossier
CtdTransport Package
FreeModel NO.
Powder InjectionSpecification
3.5mgTrademark
SinoleadOrigin
ChinaKey features
GMP Certified Quality: Manufactured under strict GMP standards ensuring high quality and safety.
OEM Production Service: Offers customized production services for generic pharmaceuticals.
CTD Dossier Available: Provides complete Common Technical Document (CTD) dossier for regulatory compliance.
Specific Indication: Indicated for multiple myeloma and relapsed/refractory mantle cell lymphoma.
Precise Dosage Regimen: Standard dose 1.3 mg/m2 twice weekly with specific adjustment protocols for toxicity.
Origin China: Manufactured in China with established export history since 2005.
Flexible Payment Terms: Accepts T/T, Western Union, Money Gram, and small-amount payments.
Fast Lead Time: Off-season delivery within 15 workdays; peak season within one month.
Company profile
Business Type: Manufacturer/Factory, Trading Company, Group CorporationExport Year: 2005-06-16Nearest Port: Guangzhou, Shenzhen, Hong KongAverage Response Time: ≤18hTerms of Payment: T/T, Western Union, Small-amount payment, etc.International Commercial Terms(Incoterms): FOB, CFR, CIF, EXW
AI-Powered supplier vetting
SummaryThe supplier is a pharmaceutical and healthcare product manufacturer with products including glutathione, ceftriaxone sodium, amoxicillin/clavulanate, and customized generics. It reports multiple management, quality, environmental, occupational safety, and pharmaceutical certifications, along with 50 R&D engineers and 50 quality-control staff. Production information confirms several pharmaceutical dosage forms, but does not provide a directly comparable capacity figure. The supplier supports sample-based, flexible, and minor customization, but explicitly lacks ODM services, SDK availability, and recent new-product development. Service procedures exist for supplier approval, assessment, and corrective actions, although records are incomplete; complaint handling has both a clear procedure and follow-up records. It has no overseas warehouse, showroom, agents, branches, or offline trade-show experience. The company states that it has registered hundreds of pharmaceutical and healthcare products worldwide and...
Supplier typeThe supplier is positioned as a pharmaceutical and healthcare manufacturer, with listed products such as injectable ceftriaxone, glutathione, oral suspension, and customized generics. Its stated activities also include supporting product registration and regulatory dossier compliance, indicating a manufacturing-oriented pharmaceutical supplier rather than a general trading-only provider.
CertificationsThe supplier lists a broad range of certifications and management-system standards, including GMP, ISO 9001, ISO 14001, ISO 14000, HACCP, BSCI, OHSAS/OHSMS 18001, and others. The slice identifies certification holdings but does not provide certificate numbers, validity periods, or scope details.
After-Sales capabilityThe supplier has a clear complaint-handling procedure with followed records, and it accepts multiple service quotation and payment terms with stated lead times within 15 working days in both peak and off-season. However, it has no overseas warehouse, showroom, overseas agents or branches, and has no overseas-service country coverage, limiting evidence of localized after-sales support.
R&D capabilityThe supplier reports 50 R&D engineers, but explicitly states that it had no new products during the past year and no available SDK. It also does not provide ODM services, so the evidence shows established R&D staffing but limited demonstrated recent innovation.
Production capacityThe supplier lists production of multiple pharmaceutical products and dosage forms, including tablets, injections, and oral suspension, and identifies pharmaceuticals and customized generics among its product keywords. It also reports 50 quality-control staff, but the provided production-output statement is not a directly usable capacity metric for comparison.
Customization capabilityThe supplier explicitly offers customization from samples, flexible customization, and minor customization. This supports tailored production, although the supplier separately states that it does not provide ODM services.
Product Q&A
Q:What is the recommended dosage for Bortezomib for Injection?
A:
The recommended dose is 1.3 mg/m2 administered as a single injection twice a week for 2 weeks, followed by 10 days of discontinuation.
Q:What conditions does this product treat?
A:
It is indicated for patients with multiple myeloma who have received at least two prior treatments and for relapsed or refractory mantle cell lymphoma.
Q:Is the product customizable?
A:
Yes, the product offers OEM services and customized production of generics, including CTD dossier options.
Q:What are the common side effects?
A:
Common side effects include peripheral neuropathy, hypotension, and potential heart disease issues like congestive heart failure.
Q:How should dose adjustments be made for toxicity?
A:
If grade 3 non-hematologic or grade 4 hematologic toxicity occurs, discontinue treatment. Upon resolution, resume with a 25% dose reduction.
Send Inquiry
*To:
Guangzhou Sinolead Biotech Co., Ltd.
Guangzhou Sinolead Biotech Co., Ltd.*Content:
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