
Hexidine Gargle
Form: Liquid Gargle
Strength: 0.12% or 0.2% chlorhexidine gluconate
Reference Brands: Hexidine(US)
Category: ENT
Hexidine gargle, containing chlorhexidine gluconate, is approved in the US by the FDA and in the EU via EMA for oral hygiene, periodontal therapy, and sore throat relief. Regulatory approval requires dossiers including safety data, manufacturing standards, efficacy evidence, and pharmacovigilance plans. The FDA reviews clinical and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For dossier preparation, regulatory pathways, and market access guidance, visit PharmaTradz. Proper adherence supports swift approval, safe administration, and global availability, helping consumers worldwide maintain oral health, prevent infections, and support mucosal healing with high-quality, regionally compliant formulations supported by regional regulations.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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