meropenem Powder for solution for injection/infusion 500 mg, 1 g

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
EU GMP, FDA
Manufacturer #17457
In the past fifty years, the company has reached significant milestones—a result of enviable performance, strict adherence to the highest ethical and operational standards, and full compliance with global regulatory authorities. During this journey, they have emerged as one of the leading in-house development partners based in Europe, specializing in the development, registration, manufacturing, and life-cycle management of highly complex pharmaceutical technologies and generic formulations.

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Meropenem

Meropenem is a broad-spectrum antibiotic. It is used in the treatment of a variety of bacterial infections which include meningitis, intra-abdominal infection, pneumonia, sepsis, and anthrax. It is also prescribed to treat Complicated Skin and Skin Structure Infections in both adult & Paediatric Patients 3 Months Of Age And Older Only, Complicated Intra-Abdominal Infections in adults and Paediatric Patients, for Bacterial Meningitis in Paediatric patients 3 Months Of Age or Older Only. Meropenem is sold under the brand names Merrem, Acus, and Adipen among others. Sumitomo Pharmaceuticals Company filed the first patent of Meropenem in 1983. It was approved for sales in the USA by the FDA in 1996. Due to its efficacy can safety record, it has earned a place on the WHO's List of Essential Medicines, and it classified Meropenem as critically important for human medicine.

Dosage Forms & administration

Meropenem is sold as a powder for an injectable solution in 500 mg and 1g vials. It is administered through an injection into the vein. For treating Complicated Skin and related Structure Infections, it can be prescribed as a single agent therapy caused by Staphylococcus aureus, pyogenes, agalactiae, viridans group streptococci, Enterococcus faecalis, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Bacteroides fragilis, and Peptostreptococcus species., the usual recommended adult dose is 500 mg given through an IV every 8 hours. For Complicated Intra-abdominal Infections, the dose is set at 1 g, given every 8 hours. In the treatment of Community-Acquired Pneumonia, the dose is 500 mg given every 8 hours and the course is given for less than 5 days.

The price of Meropenem

In the USA, the consumer pays USD41 for a supply of 10 powder for injections of intravenous powder for injection of 500 mg. the cost of this medicine is significantly lower in the developing world, in India, a 1g injection cost around USD15.

How does Meropenem work?

Meropenem’s bactericidal activity results from the inhibition of cell wall synthesis. Meropenem works by penetrating the cell wall of Gram-positive and Gram-negative bacteria to reach the penicillin-binding- proteins. It has the highest affinities are toward PBPs 2, 3, and 4 of Escherichia coli and Pseudomonas aeruginosa and other similar infectious bacteria.

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