Denosumab(Others approved) bulk supplier for pharma manufacturers

Denosumab(Others Approved) Suppliers & Bulk Manufacturers

Available Forms: Subcutaneous injection

Available Strengths: 60 mg, 120 mg

Reference Brands: Xgeva(US & EU) Ospomyv, Xbryk, Merilog, Stoboclo, Zadenvi, Enwylma, Denbrayce, Izamby - biosimilar to Xgeva

Category: Biosimilars

Denosumab(Others approved) is available in Subcutaneous injection and strengths such as 60 mg, 120 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Denosumab(Others approved) is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Denosumab(Others approved) can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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Product Description:

Biosimilars of Xgeva (denosumab) are regulated in the EU and US, supported by dossiers demonstrating biosimilarity, safety, efficacy, and manufacturing quality in compliance with GMP standards. In the US, FDA approval involves extensive comparison, clinical validation, and safety data. In the EU, CE marking certifies conformity under the MDR. These biosimilars undergo validation, stability testing, and audits, supported by comprehensive documentation including biosimilarity, clinical trial data, safety profiles, and manufacturing practices. For licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to affordable, high-quality denosumab biosimilars, supporting osteoporosis and bone metastasis treatment worldwide.

Frequently Asked Questions

Yes, Denosumab(Others approved) is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Denosumab(Others approved) is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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