Qilu Pharmaceutical's Meropenem for Injection Approved and Deemed to Have Passed Consistency Evaluation

Just now (August 1), Qilu Pharmaceutical announced that its anti-infective drug, Meropenem for Injection, has been approved for marketing by the National Medical Products Administration and is deemed to have passed the consistency evaluation. So far, Qilu Pharmaceutical has a total of 135 products that have passed or are deemed to have passed the consistency evaluation, of which 51 are the first in China.

It is reported that Meropenem is a second-generation broad-spectrum carbapenem antibiotic, which can penetrate the cell walls of most Gram-positive and Gram-negative bacteria. It exerts its bactericidal effect by inhibiting the synthesis of peptidoglycan. It has potent antibacterial activity against aerobic or anaerobic Gram-positive bacteria, Gram-negative bacteria, including multidrug-resistant strains and Pseudomonas aeruginosa. Notably, its inhibitory effect on Gram-negative bacteria is particularly prominent.

Meropenem for Injection is clinically used for infections caused by single or multiple bacteria sensitive to meropenem in adults and children, such as pulmonary infections, urinary tract infections, intra-abdominal infections, gynecological infections, skin and soft tissue infections, meningitis, sepsis, etc. It can also be used to treat moderate to severe infections in immunocompromised patients with unidentified pathogens, critically ill patients with mixed infections of aerobic and anaerobic bacteria, and severe infections caused by multidrug-resistant Gram-negative bacteria. With a broad antibacterial spectrum, significant efficacy, few adverse reactions, low resistance rate, and low cost, it is a first-line drug for the clinical treatment of severe infections.

Throughout the entire R&D process, researchers from Qilu Pharmaceutical adhered to the concept of "Quality by Design" as always. They simultaneously developed products with the same quality standards for the Chinese market and international markets, referencing pharmacopeias from various countries and relevant ICH guidelines. A systematic and comprehensive pharmaceutical comparative study was conducted between their self-produced product and the reference product. The results showed that the self-produced product and the reference product are of consistent quality and clinically safe and equivalent. This product has also been registered in Europe and has already been approved for marketing.

It is reported that the anti-infective field is a key area of strength for Qilu Pharmaceutical. Injectable Meropenem is the third approved carbapenem product developed by Qilu Pharmaceutical, following injectable Biapenem and injectable Ertapenem. The approval of this product will further enrich Qilu Pharmaceutical's product line and meet a wider range of clinical medication needs.

Editor: Muyan

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