Indomethacin Suppositories

Form: Suppositories

Strength: 25 mg, 50 mg

Reference Brands: Indocin(US & EU)

Category: Analgesic

Indomethacin suppositories are approved in the EU and US for short-term management of pain and inflammation, particularly in patients who cannot take oral medications. In the EU, they are regulated by EMA and require dossiers demonstrating safety, efficacy, and quality standards. In the US, FDA approval is based on extensive clinical data, with biosimilarity assessments and pharmacovigilance. Both regions require detailed dossiers for initial approval and continuous safety monitoring. For regulatory support, dossier preparation, and registration assistance, visit PharmaTradz. We ensure smooth market access for indomethacin suppositories, aligning with European and US regulatory standards for safe, effective anti-inflammatory therapy.