Ertapenem

In the clinical treatment of multidrug-resistant bacterial infections, carbapenem antibiotics have long occupied a core position. As a long-acting 1β-methyl carbapenem, ertapenem exerts a bactericidal effect by inhibiting the synthesis of bacterial cell wall mucopeptides, and has broad-spectrum antibacterial activity against Gram-positive, Gram-negative bacteria and anaerobic bacteria. It is mainly used clinically for the treatment of moderate to severe infections such as complicated intra-abdominal infections, complicated skin and skin structure infections, community-acquired pneumonia, complicated urinary tract infections, and acute pelvic infections. Its applicable population covers adults and children over 3 months old. With the convenience of once-daily administration, it is one of the preferred options for initial empirical treatment of mild to moderate resistant bacterial infections.

The global market size of ertapenem is approximately USD 2.2 billion. Driven by the growing demand for perioperative prophylactic medication and the improvement of the drug-resistant bacteria prevention and control system in recent years, the compound annual growth rate has remained at around 4.7%. In terms of the domestic market, the terminal sales in public hospitals exceeded RMB 1.8 billion in 2023, among which generic drugs accounted for more than 85%. Up to now, generic preparations from 16 enterprises have passed the consistency evaluation. After centralized procurement, the price of preparations has dropped by more than 70%, further promoting the improvement of clinical penetration. In the upstream API segment, ertapenem APIs produced by domestic enterprises not only meet domestic demand, but also are supplied to more than 30 countries and regions around the world, making it an important variety in the export of carbapenem APIs.

The original research enterprise of ertapenem is Merck Sharp & Dohme, with the trade name "Invanz". The expiration date of its core compound patent in the United States is 2017, and the expiration date of the compound patent in China is 2016. The main dosage form approved for the original drug is ertapenem for injection, with a specification of 1g per vial. It has been included in the *Reference Preparations Catalogue of Chemical Drugs* issued by the NMPA, and is also listed in the FDA Reference Preparations Catalogue. At present, 12 domestic enterprises have completed the registration of ertapenem APIs in the CDE (status A), and a total of 21 enterprises have obtained approval for the marketing of ertapenem for injection preparations. (Data as of September 2024, please refer to the official CDE website for the latest information)

CATO provides a full set of impurity reference standards for ertapenem API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. The products comply with the compliance requirements of multiple regulations including the Chinese Pharmacopoeia and FDA, and can provide stable and reliable impurity research solutions for API manufacturers, preparation R&D institutions and quality inspection departments, effectively shortening the R&D and declaration cycle and reducing the cost of quality research.