Ketorolac Injection Manufacturer in India

Product Details

Ketorolac Injection — manufactured at 9M India

Product Specifications

Generic Name: Ketorolac Tromethamine
Strength: 15mg/mL · 30mg/mL
Dosage Form: Solution for Injection (Ampoule)
Route: Intramuscular (IM) / Intravenous (IV)
Container: Type I neutral glass ampoule — 1mL (15mg) · 1mL (30mg)
Closure: Heat-sealed ampoule
Storage: Store below 25°C · Protect from light
Shelf Life: 24 months
Manufacturing: WHO-GMP certified sterile cleanroom · Grade A/B aseptic fill-finish
Regulatory Status: DCGI approved · Manufacturing licence held
Available For: Contract manufacturing · Third-party manufacturing · Direct supply

Ketorolac is the only NSAID approved for parenteral use in acute pain management — making it a high-value injectable for post-operative, trauma and emergency settings. It provides analgesic efficacy comparable to moderate-dose opioids without opioid-associated respiratory depression. Frequently tendered in surgical hospital formularies and prescribed in emergency departments.

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Manufacturing & Compliance

How Ketorolac Injection is manufactured at 9M India

Sterile cleanroom manufacture

Ketorolac injection is manufactured as an aqueous solution filled aseptically into Type I glass ampoules under Grade A laminar airflow in a classified cleanroom environment. Heat-sealed ampoule closure is validated for container closure integrity. Solution pH is adjusted and buffered during preparation to maintain chemical stability throughout shelf life.
In-house QC release testing — every batch

Sterility · Bacterial endotoxins (LAL, <0.25 EU/mL) · Visible particulate matter · pH (6.9–7.9) · Assay by HPLC (95.0–105.0%) · Related substances · Colour and clarity — all tested in-house before batch release.
Documentation available within 24 hours

DCGI manufacturing licence · WHO-GMP Certificate · Certificate of Analysis · Certificate of Conformance · Stability data (real-time and accelerated, ICH-aligned) · Batch manufacturing record summary — pre-prepared and available within 24 hours for tender submission, export registration or CDMO due diligence.