Product/Composition:- | Indomethacin Suppositories |
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Strength:- | 25 mg, 50 mg |
Form:- | Suppositories |
Reference Brands:- | Indocin(US & EU) |
MOQ | As per the manufacturer batch size |
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Indomethacin suppositories inhibit cyclooxygenase enzymes (COX-1 and COX-2), reducing prostaglandin synthesis responsible for pain and inflammation. Benefits include rapid, targeted relief for acute pain, especially for patients unable to take oral medications, with effective anti-inflammatory action and minimal systemic side effects when used appropriately.
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.