Product/Composition:- | Clarithromycin ER tablets |
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Strength:- | 500 mg |
Form:- | Extended-Release Tablets |
Reference Brands:- | Biaxin (EU & US) |
MOQ | As per the manufacturer batch size |
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Clarithromycin ER tablets inhibit bacterial protein synthesis by binding to the 50S ribosomal subunit, blocking translocation. They effectively treat respiratory, skin, and Helicobacter pylori infections. Benefits include rapid, broad-spectrum activity, improved tissue penetration, and convenient once-daily dosing for long-term infection management.
Clarithromycin ER (Extended-Release) tablets are approved in the EU and US for respiratory, skin, and Helicobacter pylori infections. In the EU, brands like Biaxin XL are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval is based on extensive clinical data, with generics available. Both regions require detailed dossiers, clinical trial results, manufacturing standards, and pharmacovigilance plans for approval and safety monitoring. For expert assistance with regulatory dossiers, compliance, and registration, visit PharmaTradz. We facilitate seamless market access for clarithromycin ER tablets, ensuring adherence to European and US standards for safe, effective antibiotic therapy.