Labetalol Injection Manufacturer in India

Product Details

Labetalol Injection — manufactured at 9M India

Product Specifications

Generic Name: Labetalol Hydrochloride
Strength: 5mg/mL (100mg/20mL)
Dosage Form: Solution for Injection
Route: Intravenous (IV)
Container: Type I glass ampoule — 20mL
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

Labetalol IV is the drug of choice for hypertensive emergencies, pre-eclampsia/eclampsia in pregnancy, perioperative hypertension and hypertensive crisis in ICU and emergency settings. Its combined alpha and beta blocking action provides rapid, controlled blood pressure reduction. On the WHO Essential Medicines List. High-demand item in emergency departments, ICUs, obstetric units and surgical theatre formularies.

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Manufacturing & Compliance

How Labetalol Injection is manufactured at 9M India

Sterile cleanroom manufacture

Labetalol HCl solution prepared in Water for Injection at 5mg/mL concentration with pH adjustment (3.0–4.5) and sterile-filtered through 0.22 micron membrane. Aseptically filled into 20mL Type I glass ampoules under Grade A laminar airflow. Heat-sealed closure validated for integrity. Nitrogen overlay during filling to minimise oxidation.
In-house QC release testing — every batch

Sterility · Bacterial endotoxins (<0.25 EU/mL) · pH (3.0–4.5) · Assay by HPLC (95.0–105.0%) · Related substances · Visible particulate matter · Colour and clarity — all 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.