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Labetalol bulk supplier for pharma manufacturers

Labetalol Suppliers & Bulk Manufacturers

Available Forms: Tablet / Injection

Available Strengths: 100 mg, 200 mg, 5mg/ml

Reference Brands: Trandate (USA/India), Normodyne (LATAM)

Category: Hypertension

Labetalol injection is used to treat severe high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. Labetalol is available in Tablet / Injection and strengths such as 100 mg, 200 mg, 5mg/ml. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Labetalol is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Labetalol can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

Product Description:

Labetalol is a combined alpha- and beta-adrenergic blocker widely used for the management of hypertension, particularly in acute and chronic cardiovascular conditions. By reducing heart rate and cardiac output (beta-blockade) and relaxing blood vessels (alpha-blockade), labetalol effectively lowers blood pressure while offering cardiovascular protection. It is FDA-approved for treating arterial hypertension, ranging from stable chronic cases to acute hypertensive crises, making it a versatile option in both inpatient and outpatient settings.

In clinical practice, labetalol is also commonly used off-label for acute hypertension during pregnancy, as well as hypertension associated with acute ischemic stroke and intracranial hemorrhage, including subarachnoid hemorrhage. Its dual mechanism of action provides rapid blood pressure control, making it a preferred choice in emergencies.

Labetalol therapy requires careful patient selection, monitoring, and awareness of contraindications, as its negative inotropic and chronotropic effects can impact cardiac function. Overall, labetalol plays a critical role in cardiovascular management, offering both acute intervention in hypertensive crises and long-term control in chronic cardiovascular disease, thereby contributing to reduced morbidity and mortality in eligible patient populations.

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Frequently Asked Questions

Labetalol Injection is used to manage high blood pressure, including hypertensive emergencies and severe hypertension. It is commonly used in hospital settings for rapid blood pressure control, especially in conditions like pre-eclampsia/eclampsia, acute hypertensive crises, and after certain surgeries.

It contains Labetalol hydrochloride, a combined alpha- and beta-adrenergic blocker. Labetalol works by relaxing blood vessels (alpha-blockade) and reducing heart rate and cardiac output (beta-blockade), thereby lowering blood pressure effectively.

Common trade names include Trandate Injection, Normodyne Injection, and generic Labetalol Injection.

It is manufactured by several pharmaceutical companies, including Pfizer, Mylan, Sun Pharma, and various generic manufacturers worldwide.

Labetalol hydrochloride.

Trandate, Normodyne, and various country-specific generics.

It is primarily manufactured in India, Europe, and the USA, and supplied globally depending on regulatory approvals.

Yes, Labetalol is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Labetalol is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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