The proposal was submitted under file number SND/CT21/FF/2025/5 (0234), wherein the firm sought regulatory approval for manufacturing and marketing Faropenem Sodium Dispersible Tablets in strengths of 50 mg and 100 mg. During the meeting, the company presented its justification for seeking a waiver from conducting fresh clinical trials and BE studies.
The committee carefully examined the application and noted that the proposed posology and dosage schedule of the applied drug is consistent with the existing approved dosage regimen. Based on this assessment, the SEC concluded that additional clinical trial and BE study data were not required for the proposed formulation.
After detailed deliberations, the committee recommended granting permission for the manufacturing and marketing of the drug along with the requested waivers, marking a positive regulatory outcome for the applicant.
Faropenem Sodium is a broad-spectrum oral beta-lactam antibiotic belonging to the penem class. It is primarily used in the treatment of bacterial infections, particularly in pediatric and adult patients suffering from respiratory tract infections, urinary tract infections, skin and soft tissue infections, and other susceptible bacterial conditions. The dispersible tablet formulation is especially beneficial in pediatric use due to improved ease of administration and better patient compliance.
Akums Healthcare is one of India’s pharmaceutical contract manufacturing and development organizations, with a strong presence in the production of oral solid dosage forms, injectables, and specialty formulations. The company supplies products across domestic and international markets and is known for its regulatory-compliant manufacturing infrastructure.
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