Anakinra Injection Suppliers & Bulk Manufacturers

Available Forms: Injection(SQ)

Available Strengths: 100 mg/mL

Reference Brands: Kinerso, Kineret(US)

Category: Immune Disorder

Anakinra injection is available in Injection(SQ) and strengths such as 100 mg/mL. 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, Anakinra injection is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Anakinra injection 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.

Product Description: Anakinra prefilled pens, marketed as Kineret, are approved in both the US by the FDA and in the EU via EMA for rheumatoid arthritis, Still's disease, and autoinflammatory conditions. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety, manufacturing quality, and pharmacovigilance data. In the US, the FDA reviews detailed clinical trial and manufacturing information, while the EMA ensures compliance with regional standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance is essential for timely approval, supporting safe and effective treatment options for autoimmune and autoinflammatory diseases worldwide.