
Azithromycin Suspension
Form: Suspension
Strength: 100 mg/5 mL, 200 mg/5 mL, 400 mg/5 mL
Reference Brands: Zithromax, Z-Pak(US); Zidimax(EU)
Category: Medical Aid
Azithromycin suspension is approved in the EU and US for pediatric and adult bacterial infections, including respiratory and skin infections. In the EU, brands like Zithromax are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data; generic suspensions are available. Both regions require detailed dossiers, including clinical trial results, manufacturing quality, and pharmacovigilance plans for approval and ongoing safety. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We support seamless market access for azithromycin suspension, ensuring adherence to European and US standards for safe, effective antimicrobial therapy.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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