Daptomycin with GMP and EGMP DMF made in China 103060-53-3
AI Product Description
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Daptomycin is a lipopeptide antibiotic produced by the fermentation of *Streptomyces roseosporus*. It functions as a bactericidal agent specifically targeting Gram-positive bacteria, including methicillin-resistant *Staphylococcus aureus* (MRSA), vancomycin-resistant *Enterococcus faecium* (VRE), and penicillin-resistant *Streptococcus pneumoniae*. The molecule operates through a unique mechanism: upon binding to the bacterial cell membrane in a calcium-dependent manner, it induces rapid depolarization, leading to the loss of membrane potential and subsequent inhibition of protein, DNA, and RNA synthesis. This action results in swift bacterial cell death.
The chemical identity of Daptomycin is defined by its molecular formula C66H97N13O16S2 and a CAS Registry Number of 150144-83-9. Its complex structure features a cyclic peptide backbone linked to a decanoyl side chain, which is essential for its membrane-interacting activity. Manufacturers in China have increasingly focused on producing high-quality Daptomycin that complies with Good Manufacturing Practice (GMP) standards. Furthermore, many Chinese facilities maintain European GMP (EGMP) compliance and possess Drug Master Files (DMF) registered with major regulatory bodies, facilitating global market access and ensuring rigorous quality control throughout the production process.
Clinically, Daptomycin is primarily indicated for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible organisms, as well as for Staphylococcus aureus bloodstream infections (bacteremia) and right-sided infective endocarditis. It is also utilized for VRE infections. Due to its potent efficacy against resistant pathogens, it serves as a critical therapeutic option when other antibiotics fail or are contraindicated. While generally well-tolerated, monitoring for creatine phosphokinase elevation is recommended during therapy. The availability of GMP and EGMP-certified Daptomycin from Chinese manufacturers ensures a reliable supply chain for pharmaceutical companies worldwide, supporting the development of injectable formulations for hospital and clinical use.