Imipenem

Infection caused by multidrug-resistant bacteria is the core difficulty in current clinical anti-infective therapy. As the last line of defense for the treatment of severe infections caused by Gram-negative bacteria, carbapenem antibiotics have always been the focus of research and development in the anti-infective field. Imipenem is a carbapenem β-lactam antibiotic, which exerts a bactericidal effect by inhibiting the synthesis of bacterial cell wall mucopeptide. Its antibacterial spectrum covers Gram-positive, Gram-negative aerobic bacteria and anaerobic bacteria, and it maintains high antibacterial activity against multidrug-resistant *Pseudomonas aeruginosa*, *Acinetobacter* spp. and Enterobacteriaceae bacteria. Clinically, it is mainly used for the treatment of severe infections such as lower respiratory tract infection, abdominal infection, sepsis and urinary tract infection caused by sensitive bacteria, and is suitable for patients with immunocompromised complicated infection and mixed infection who do not respond to other antibiotic treatments. It is usually used in combination with cilastatin sodium to block its metabolic degradation in the kidney.

At present, the global market size of carbapenem antibiotics exceeds USD 3 billion, among which imipenem compound preparations account for approximately 22%, with an average annual compound growth rate of 4.8% in the past three years. For the domestic market, the sales of imipenem and cilastatin preparations in sample hospitals exceeded RMB 1.5 billion in 2023, making it the second most used carbapenem variety in clinical practice. At present, the share ratio of original research drugs and generic drugs in the domestic preparation market is approximately 3:7, the supply of API has basically achieved localization, and generic drugs from more than 15 enterprises have passed the consistency evaluation. After winning the bid in the fifth batch of national centralized drug procurement, the terminal price has dropped by more than 70%, and the accessibility in primary medical institutions has been significantly improved.

The original research enterprise of imipenem is Merck Sharp & Dohme, and the trade name of its original research compound preparation is TIENAM®. The core compound patent expired globally in 2009. The original reference listed drug is in the form of powder for injection, with the conventional specification of 0.5g imipenem/0.5g cilastatin, which has been included in the *Catalogue of Chemical Reference Listed Drugs* of China and the FDA reference listed drug catalogue. According to the domestic API registration platform, nearly 20 enterprises have obtained A-status registration numbers for their imipenem APIs after approval by the CDE, and more than 20 domestic manufacturers have obtained approval for preparations, ensuring sufficient and stable clinical supply. (Data as of October 2024, please refer to the official website of CDE for the latest information)

In response to the demand for quality research and registration of imipenem, CATO provides a full set of impurity reference standards for this API, covering all research dimensions such as related substances, isomers and degradation products. Most products are available from stock. Orders for in-stock products placed before 16:00 can be shipped on the same day. All reference standards comply with the compliance requirements of multiple regulatory systems such as the Chinese Pharmacopoeia and FDA, and can directly support process validation, quality research and registration declaration related work.