Ropivacaine Injection Manufacturer in India | WHO-GMP Regional Anaesthesia Injectable

Product Details

Propofol Injection — manufactured at 9M India

Product Specifications

Generic Name: Propofol

Strength: 10mg/mL
Dosage Form: Emulsion for Injection or Infusion
Route: Intravenous (IV)
Container: Type I glass vial — 20mL · 50mL · 100mL
Closure: Rubber stopper + aluminium crimp seal
Storage: Store between 2–25°C · Do not freeze · 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

Propofol is the gold standard IV anaesthetic for induction and maintenance of general anaesthesia in adults and children, and for ICU sedation of mechanically ventilated patients. Its rapid onset (30–60 seconds), short duration and smooth recovery profile make it the preferred anaesthetic in modern surgical practice. High-volume procurement item in all surgical hospital formularies and government anaesthesia drug lists.

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Manufacturing & Compliance

How Propofol Injection is manufactured at 9M India

Sterile cleanroom manufacture

Propofol injection is an oil-in-water emulsion containing Propofol in soybean oil, egg lecithin and glycerol — requiring specialised emulsion manufacturing capability. Prepared by high-shear emulsification, aseptically filled into Type I glass vials under Grade A laminar airflow with nitrogen overlay to prevent oxidation. Emulsion droplet size distribution validated by laser diffraction on each batch.
In-house QC release testing — every batch

Sterility · Bacterial endotoxins (<0.5 EU/mL) · Visible particulate matter · pH (6.0–8.5) · Assay by HPLC (95.0–105.0%) · Emulsion droplet size (D50 <0.5 micron) · Free fatty acids · Colour (white opaque emulsion) — all tested in-house. COA per batch.
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.