Product/Composition:- | Tigecycline Intravenous (IV) Solution |
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Strength:- | 50 mg/2 mL, 100 mg/2 mL, 50 mg/100 mL, 100 mg/100 mL |
Form:- | Intravenous (IV) Solution |
Reference Brands:- | Tygacil(US) |
MOQ | As per the manufacturer batch size |
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Tigecycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, blocking aminoacyl-tRNA attachment. It provides broad-spectrum activity, including multidrug-resistant bacteria. Benefits include rapid bacterial eradication, effectiveness against complicated intra-abdominal and skin infections, and use in severe infections unresponsive to other antibiotics.
Tigecycline IV is approved in the EU and US for complicated intra-abdominal and skin infections. In the EU, brands like Tygacil are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing quality. In the US, FDA approval is based on extensive clinical data; generic versions are available. Both regions require detailed dossiers, including clinical trial results, manufacturing standards, and pharmacovigilance plans, for approval and safety monitoring. Due to its broad-spectrum activity against resistant bacteria, strict prescribing controls are enforced. For regulatory support, dossier preparation, and compliance, visit PharmaTradz. We facilitate seamless market access for tigecycline IV, ensuring adherence to European and US regulatory standards.