Gufic Bioscience Told To Submit More Data for Piperacillin-Tazobactam-Sodium Chloride FDC
New Delhi: In response to the proposal presented by Gufic Bioscience, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined that firm to submit more scientific literature available from peer reviewed journal in support of the proposed fixed dose combination (FDC) Piperacillin plus Tazobactam pluss Sodium Chloride.
This came after the firm presented their proposal along with justification for BE & Phase III CT waiver before the committee.
Piperacillin is a broad-spectrum antibiotic used to treat various bacterial infections, often combined with tazobactam to enhance its effectiveness against bacteria that produce beta-lactamase enzymes.
Tazobactam is a beta-lactamase inhibitor used in combination with the antibiotic piperacillin to treat bacterial infections. It works by preventing bacteria from destroying piperacillin, allowing the antibiotic to effectively kill the bacteria.
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