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ANFARM HELLAS S.A. sell "Ertapenem Pd.C.So.In 1g/Vial (under development)"

Basic Information

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Trade Type

Sell

Product Name

Ertapenem Pd.C.So.In 1g/Vial (under development)

Manufacturer(s)

Specifications

  • Sterility: Complies with sterility test requirements per USP <71>/Ph.Eur. 2.6.1 for parenteral products.
  • Bacterial Endotoxins: Meets bacterial endotoxin limits per USP <85>/Ph.Eur. 2.6.14, confirmed by validated LAL testing.
  • Particulate Matter: Complies with sub-visible particulate matter limits per USP <788>/Ph.Eur. 2.9.19.
  • Container Closure Integrity: Container closure system validated to maintain sterility and product integrity throughout shelf life.

Other Information

Additional Description:

Ertapenem 1 g powder for concentrate for solution for infusion, referencing Invanz (MSD). Ertapenem is a carbapenem antibiotic indicated for pediatric patients and adults for infections caused by bacteria known or highly likely to be susceptible, when parenteral therapy is required, including intra-abdominal infections, community-acquired pneumonia, acute gynecological infections, and diabetic foot skin/soft-tissue infections, and in adults for prophylaxis against surgical site infection following elective colorectal surgery. The dossier is in progress with timelines to be defined, stability studies cover Zone II and Zone IVb, the originator's shelf life is two years, and batch and pack sizes are to be determined (originator packs of 1 or 10 vials).
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