ANFARM HELLAS S.A. sell "Ceftaroline Fosamil Pd.C.So.In 600mg/Vial (under development)"
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Sell
Product Name
Ceftaroline Fosamil Pd.C.So.In 600mg/Vial (under development)
Manufacturer(s)
Specifications
- Sterility: Sterile; complies with USP <71> / Ph. Eur. 2.6.1 sterility test requirements.
- Bacterial Endotoxins: Bacterial endotoxins ≤ 0.5 EU/mL, per USP <85> / Ph. Eur. 2.6.14 (LAL test).
- Particulate Matter: Meets USP <788> / Ph. Eur. 2.9.19 limits for sub-visible particulate matter in parenteral solutions.
- Container Closure Integrity: Glass vial with rubber stopper and aluminium flip-off seal; verified for closure integrity
- Content Uniformity: Complies with USP <905> / Ph. Eur. 2.9.40 content uniformity acceptance criteria (acceptance value ≤ 15).
Other Information
Additional Description:
This ceftaroline fosamil powder for concentrate for solution for infusion (600 mg/vial), referencing Zinforo (Pfizer), is intended for neonates, infants, children, adolescents, and adults with complicated skin and soft tissue infections or community-acquired pneumonia, subject to official antibacterial-use guidance. The dossier is in progress, with stability studies covering Zone II/IVb, an originator shelf life of three years, batch size to be defined, and pack sizes to be defined, with the originator pack at 10 vials per box.
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