
Tramadol Hydrochloride Tablets
Form: Tablets(IR/ER)/ Capsules
Strength: Capsules, Tablet(IR: 50 mg; ER:00 mg, 200 mg, and 300 mg)
Reference Brands: Ultram(US)
Category: Active Pharmaceutical Ingredient
Tramadol Hydrochloride is approved in the US and EU, supported by robust dossiers demonstrating safety, efficacy, and manufacturing quality in compliance with GMP and IVDR standards. In the US, FDA regulates tramadol as a Schedule IV controlled substance, requiring strict post-market surveillance. In the EU, CE marking certifies conformity with in vitro diagnostic regulations. These assessments include clinical trial data, safety profiles, and manufacturing audits. For detailed licensing procedures, approved dossiers, and the latest regulatory updates, visit Pharmatradz. Ensuring compliance guarantees access to safe, effective tramadol products for pain management worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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