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Product Details

Lidocaine Injection — manufactured at 9M India

Product Specifications

Generic Name: Lidocaine Hydrochloride (Lignocaine HCl)
Strength: 1% (10mg/mL) · 2% (20mg/mL)
Dosage Form: Solution for Injection
Route: Local infiltration · Nerve block · Epidural · IV (antiarrhythmic)
Container: Type I glass ampoule (2mL, 5mL, 10mL) · Type I glass vial (20mL, 50mL)
Closure: Heat-sealed ampoule / Rubber stopper + aluminium crimp (vial)
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

Lidocaine is the most widely used local anaesthetic globally — indicated for infiltration anaesthesia, nerve blocks, epidural anaesthesia and surface anaesthesia across surgical, dental, obstetric and emergency settings. It is also used IV for ventricular arrhythmia management. On the WHO Essential Medicines List. High-frequency procurement item across all hospital formularies and government tender schedules.

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Manufacturing & Compliance

How Lidocaine Injection is manufactured at 9M India

Sterile cleanroom manufacture

Lidocaine HCl solution is prepared in purified water with pH adjustment (5.0–7.0 range) and sterile-filtered through a 0.22 micron membrane. Aseptic filling into ampoules and vials under Grade A laminar airflow in classified cleanroom. Both heat-sealed ampoule and rubber-stoppered vial formats are validated at our facility.
In-house QC release testing — every batch

Sterility · Bacterial endotoxins (LAL, <0.25 EU/mL) · pH (5.0–7.0) · Assay by HPLC (95.0–105.0%) · Related substances · Visible particulate matter · Sub-visible particles — 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.