FreeOTC
Paracetamol Tablets IP 500 mg
Paracetamol (Acetaminophen)
Target markets: Africa, SE Asia, LatAm, CIS
APIsFreely Exportable
Paracetamol API
Paracetamol (Acetaminophen), USP/EP grade
WHO-GMP Partner-Manufactured
Target: EU/UK, SE Asia, LatAm
Regulatory-Aware Support
Reliable Supply Chain
Product Overview
Bulk-grade Paracetamol API for formulators and contract manufacturers, supplied with a Certificate of Analysis and open-part dossier support for Tier 2 and 3 buyers.
Key Points
- USP/EP/BP grade bulk API
- Certificate of Analysis provided with every batch
- Open-part dossier support available; CEP/DMF status confirmed per manufacturing partner
Quick Specifications
| Generic Name | Paracetamol (Acetaminophen), USP/EP grade |
|---|---|
| Dosage Form | Bulk powder (API) |
| Strength | USP/EP/BP grade |
| HS Code | 2922 / 3004.90 |
| Packaging | 25 kg fibre drums, customisable on request |
| MOQ | MOQ on request |
| Shelf Life | 36 months, batch-dependent |
| Storage | Store in original packaging, below 25°C |
Regulatory Information
OTC — No Prescription
Not retail-dispensed. Supplied to manufacturers and formulators. A European CEP or US DMF is the entry ticket for Tier 1 buyers; Tier 2/3 buyers typically work off a Certificate of Analysis.
View Active Pharmaceutical Ingredients (APIs) class detailsRequirements vary by destination. Verify current requirements with the relevant authority before shipment. See our Compliance page.
Need documentation first?
Our team can share a product brochure and manufacturing-partner regulatory summary on request — just mention it in your enquiry.