WHO-GMP Certified Commercial Pack · Product Code: AKP-054
Diclofenac Sodium 75mg Injection (per ml)
Formulation Overview: Low-viscosity aqueous/solubilized 1 ml high-concentration NSAID injection formulated for painless deep intragluteal IM or diluted IV analgesia in emergency trauma rooms. Formulated with Diclofenac Sodium IP 75 mg (per 1 ml aqueous base) (75 mg / 1 ml) in Sterile Liquid Injection Ampoule dosage form under Pain, Inflammation & NSAIDs, manufactured to IP / BP / USP Compendial standards and supplied in 10 x 1 ml Amber USP Type I Glass Ampoules (Trauma-Tray Carton) with complete eCTD/ACTD regulatory dossiers, Zone IVb stability, and batch CoA for African NRAs (NAFDAC, PPB, SAHPRA, TMDA, FDA Ghana) and global tenders.
| Item Code (SKU) | AKP-054 |
|---|---|
| Therapeutic Sector | Pain, Inflammation & NSAIDs |
| Dosage Form | Sterile Liquid Injection Ampoule |
| Active Ingredient | Diclofenac Sodium IP 75 mg (per 1 ml aqueous base) |
| Strength / Purity | 75 mg / 1 ml |
| Clinical Indication | Acute renal colic, biliary colic, post-operative severe pain, acute gout flare, and orthopedic trauma |
| Specification Standard | IP / BP / USP Compendial |
| Packaging Format | 10 x 1 ml Amber USP Type I Glass Ampoules (Trauma-Tray Carton) |
| Shelf Life | 24–36 Months |
| Storage Conditions | Store below 25°C; protect from light; do not freeze |
| Minimum Order Quantity | 1000 Packs |
| Regulatory / Analytical Docs | Full eCTD / ACTD Modules 1–5 + Zone IVb Stability Available |
| African & Global NRA Readiness | NAFDAC (Nigeria), PPB (Kenya), SAHPRA (SA), TMDA (Tanzania), FDA Ghana, AIRP, ARP, EFDA |
| Stock Availability | In Stock · Immediate Commercial Dispatch |
| Supply Status | Commercial Export Ready |