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Levosimendan manufacturers

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Country of origin : India

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9 products found

levosimendan

Vials, lyophilized injection 12.5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #17417
This innovative life sciences company specializes in developing, manufacturing, and marketing a range of life-saving critical care drugs and other pharmaceuticals. They focus on addressing unmet medical needs across various therapeutic areas including anesthesiology, cardiology, gastroenterology, urology, gynecology, oncology, and pediatrics. The company has manufacturing facilities strategically located in different regions and boasts a robust R&D division dedicated to innovation. They hold multiple product patents and GMP certifications, ensuring high-quality standards. Their portfolio includes both prescription medications and animal health products, targeting key regions such as North America, the EU, and Asia.

ambroxol hydrochloride + guaifenesin + levosimendan

Syrup 30 mg + 50 mg + 1 mg, 7.5 mg + 12.5 mg + 0.25 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #20267
The company is a Schedule M and ISO 9001:2015 certified pharmaceutical manufacturer based in South Asia, specializing in the production and marketing of its own pharmaceutical products, as well as offering third-party manufacturing services. Equipped with modern facilities, the company produces a range of dosage forms, including tablets, capsules, and liquid orals, under stringent quality control measures with advanced technology and dehumidified conditions. With a focus on quality and compliance, the company has established state-of-the-art Quality Control and Microbiology Laboratories to ensure high standards across its product lines, catering to both domestic and international markets.

levosimendan

Vials, injection 12.5 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
WHO
Manufacturer #10323
This company is a global manufacturer of essential lifesaving medicaments, specializing in high-tech parenteral and oral formulations. Established in 1984, it has grown from a small family business to a multinational corporation with over 2000 employees across 70 markets. Their expertise spans various therapeutic areas including anaesthesiology, critical care, pain management, gynaecology, ophthalmology, orthopaedics, oncology, and dermatology. They offer a diverse product portfolio of over 500 products, including injectables, infusions, and other dosage forms. The company prides itself on its commitment to quality, innovation, ethics, and transparency. They maintain GMP certifications and hold patents for several products. Their manufacturing sites are strategically located across key regions like the EU and North America.

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LEVOSIMENDAN

Levosimendan belongs ta category of medicines called calcium sensitisers. It is used to manage acute decompensated congestive heart failure. It works by increasing the sensitivity of the heart to calcium thus increasing cardiac contractility without arising in intracellular action. It is one of a new class of heterogeneous agents, the calcium sensitisers. Its dual mechanism of action enhances cardiac contractility and vasodilatation without affecting intracellular free calcium, thereby reducing the proarrhythmic potential. It can be administered intravenously (IV) which makes it a therapeutic option for acute decompensated Congestive Heart failure and it is tolerated well in patients with acute heart failure. It has favorable effects on neuro-hormone levels in heart failure patients. These properties make it a good medication to treat heart failure (acute and chronic), sepsis, post-resuscitation myocardial dysfunction and peri-operative optimization of cardiac patients with cardiomyopathy.
Levosimendan is sold under the brand names SIMDAX , Dopamine, Digoxin amongst others.
The Orion Corporation originally developed Levosimendan. They applied for a new drug patent in 1998 in the U.S, which was later withdrawn due to FDA request to conduct further trials. Then in 2000, Sweden became the first country to allow the sale of Levosimendan. More than 60 countries worldwide have approved the drug; however, it is yet to receive its FDA approval in North America, where it is currently in Phase III of development.

Forms and Dosage:

Levosimendan is available in a vial containing 12.5mg in 5ml. Levosimendan infusion starting dose is 0.1 mg per kilo per minute and titrated to 0.2 mg/kg/min as long as systolic blood pressure remains stable after the first 2–3 hours. In the treatment of acute heart failure, the recommended interval is 24 hours. To prevent the risk of hypotension in patients who have systolic blood pressure Initial bolus of Levosimendan is usually not administered.

The price of Levosimendan

In India, consumers have to pay $8 for 12.5 mg for injection for 1 Box of Lyophilized vial.

How does it work?

Levosimendan improves myocytes’ calcium sensitivity as it binds to troponin C in a calcium-dependent manner. The resulting outcome is an increase in contractility without raising calcium levels. Its actions relax vascular smooth muscles by opening adenosine triphosphate sensitive potassium channels.

Finding Levosimendan Manufacturers and Suppliers:

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