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labetalol

Injection 5 mg - 4 ml, 5 ml

Dossier type
EU CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Manufacturer #35915

Established in 2007, this family-owned manufacturer specializes in pharmaceutical formulations, offering over 500 products across various dosage forms, including tablets, capsules, dry syrups, ointments, dry injections, and liquid orals. As a CTD dossier owner and manufacturer, it holds WHO-cGMP certification, ensuring compliance with stringent international quality standards. The manufacturer operates advanced production lines with capacities such as 3,600 million tablets, 1,800 million capsules, 240 million liquid injections in ampoules, and 70 million dry powder injections per annum, adhering to rigorous GMP guidelines. As a CTD dossier owner and manufacturer, its products are distributed across multiple countries worldwide.

Manufacturer usually replies in 7 days

labetalol

Injection 5 mg/ml - 20 ml

Dossier type
EU CTD
Dossier status
Under development
Country of origin
India
GMP approvals
EU GMP
Comments
Ref: Trandate-Aspen
Manufacturer #19912

This global pharmaceutical company is a leading manufacturer of specialty formulations in oncology and anesthesia, with operations spanning the EU, North America, and other regions. They specialize in prescription medications, including lyophilized products, for key therapy areas such as cancer treatment and pain management. Their commitment to quality is reflected in their numerous GMP certifications, including WHO GMP, EU GMP, and TGA certifications. They prioritize innovation through research and development of new manufacturing processes and drug delivery mechanisms.

Manufacturer usually replies in 37 days

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
A pharmaceutical manufacturer with over 25 years of experience that develops and produces fixed-dose and single-entity generic and specialty pharmaceutical products. The company offers an extensive range of injectable dosage forms, including parenterals, and also manufactures oral solids. Its facilities operate under recognised international quality certifications such as EU-GMP, ANVISA, PIC/S and TGA approvals, supporting reliable large-scale production of pharmaceutical products for global export while emphasizing efficacy, affordability and consistent quality.

Manufacturer usually replies in 19 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

Finding a faithful partner in our business is one of the major tasks and to overcome this and make one’s work simple and easy in finding the trustworthy manufacturer and supplier of Labetalol, one can visit the Pipelinepharma website which helps the buyer in finding the dependable manufacturers and suppliers of Labetalol. Pipelinepharma, which is a business-to-business (B2B) licensing marketplace for pharmaceutical products, quickly connects owner with the consumers for the business development. One can filter the product names in unified search engine by its country, category, therapeutic area, forms, dossier and its status, regulatory filings, approvals, and more.

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