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Labetalol manufacturers

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22 products found

labetalol

Vials, injection 100 mg/20 ml, 20 mg/4 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #2303

Manufacturer usually replies in 6 days

labetalol

Injection 5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #20368
This company, established in the early 1980s in South Asia, has a strong focus on innovative drug delivery systems (NDDS). With over three decades of experience, it boasts multiple globally patented technologies and has grown into a significant player in the pharmaceutical sector. The company's portfolio includes a diverse range of products in therapeutic areas like pain management, gynecology, and critical care. It also develops nutraceuticals and nutritional supplements. The company offers a variety of dosage forms, including oral, injectable, and potentially liquid forms. They manufacture products in state-of-the-art facilities, adhering to stringent GMP standards. These facilities hold approvals from international regulatory agencies, including WHO, PIC/S, and ANVISA, and are currently pursuing EU and USFDA certifications. The company's footprint extends across key regions, including Asia, Africa, Latin America, and the CIS. This global reach is further strengthened by a dedicated regulatory, operational, marketing, and business development teams. The company actively engages in licensing agreements with multinational and regional players, demonstrating its commitment to innovation and partnership.

Manufacturer usually replies in 5 days

labetalol

Vials, injection 5 mg/ml - 20 ml, 40 ml

Dossier type
US CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
FDA
Comments
ANDA / R &D Status: Approved ; US RLD / Holder: "Trandate / Sebela Ireland Ltd."; Indication: Adrenergic receptor blocking agent. Used to treat high blood pressure;
Manufacturer #8216
This fast-growing pharmaceutical company boasts a dominant presence in Latin America, Francophone Africa, and a growing footprint in regulated markets like the EU and North America. Founded in 1990, it initially focused on ointments and creams before expanding its product range significantly. With over 4,000 global product licenses, they cater primarily to the "Bottom of the Pyramid" through their owned distribution networks. The company's manufacturing facility holds multiple certifications including US FDA approval (with three successful inspections since 2016), EU-GMP, ANVISA-Brazil, INVIMA-Colombia, and COFEPRIS-Mexico. They prioritize innovation with a significant portion of their earnings invested in research and development of safe and effective products across various dosage forms. Key therapy areas are not specified.

Manufacturer usually replies in 6 days

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Labetalol Manufacturers

Labetalol is a beta-blocker and belongs to class of medication called beta blockers. Labetalol is used alone or in combination to treat high blood pressure, including high blood pressure in pregnancy. This drug helps in lowering the blood pressure which ultimately helps prevent chest pain, strokes, heart attacks and kidney problems. Labetalol is also used to treat patients with tetanus. This medication is advised as a prescription product as well as generic prescription product. Labetalol is marketed by manufacturers under the Brand name of Trandate, Normodyne. This drug is issued on prescription only. Labetalol comes in two dosage forms namely, tablet which is taken by mouth and an intravenous (I.V.) injection which is administered intravenously. Labetalol Tablet is available in dosage strengths of 100 mg, 200 mg, 300 mg and Injection is available in dosage strength of 5 mg/mL. Labetalol tablets are supplied as round, film-coated engraved with brand name and dosage strength on one side. Labetalol Injection is supplied as 5 mg/mL vial in box of one. The recommended initial adult dose for hypertension is labetalol 100 mg tablet alone or in combination with other drug taken by mouth twice daily. This dose may be adjusted gradually every 3 days in order to attain steady plasma concentration. The usual maintenance dose is in between 200 mg to 400 mg twice daily. Labetalol Injection is used when the hypertension is severe and intended for use in hospitalized patients. The injection is only administered by a healthcare professional. Dosage must be individualized depending upon the severity of hypertension and the response of the patient during dosing. The recommended dosage for severe hypertension is 20 mg I.V. over 2 minutes initially, immediately before the injection and at 5 and 10 minutes after injection, supine blood pressure should be measured to elevate response then 40 or 80 mg I.V. can be given at 10-minute intervals and the total dose not to exceed 300 mg. Labetalol Tablet and Injection is recommended to store between 2° C and 30° C (36° F and 86° F). Labetalol Injection must not be freezed and should protect from light.

Wholesale Price of Labetalol

The cost for labetalol intravenous solution 5 mg/mL is around $ 12 for a supply of 20 milliliters with per unit cost comes at $ 0.60 The wholesale price of 100 mg labetalol oral tablet is approximately $ 27.63 for a quantity of 100 tablets with per unit cost available at the lowest price of approximately $ 0.28 The wholesale price of 200 mg labetalol oral tablet is approximately $ 50.59 for a set of 100 tablets with per unit cost comes at the lowest price of $ 0.51 The cost for 300 mg labetalol oral tablet is around $ 35.26 for a supply of 100 tablets with per unit cost comes at $ 0.35

Labetalol - Mechanism of Action

Labetalol blocks adrenergic receptors in the central nervous system and expand arteries resulting in a fall in blood pressure.

Finding Labetalol Manufacturers and Suppliers

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