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Labetalol bulk supplier for pharma manufacturers

Labetalol 100 mg, 200 mg, 5mg/ml 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.

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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.

Labetalol — third party manufacturing & bulk supply

Labetalol 100 mg, 200 mg, 5mg/ml is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Labetalol listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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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.

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