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Gadobutrol manufacturers

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Country of origin : India

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2 products found

gadobutrol

Solution for injection 1 mmol/ml - 15 ml, 30 ml

Dossier type
CTD
Dossier status
Ready to file
Country of origin
India
GMP approvals
EU GMP
Comments
Available for Balkans only
Manufacturer #17331
This company has been operating in the pharmaceutical industry for over five decades, demonstrating a strong commitment to healthcare solutions. They specialize in manufacturing finished dosage formulations, biosimilars, and API/DC granules, catering to diverse needs within the healthcare market. Their focus on research and development drives innovation and ensures high-quality products, while their commitment to regulatory compliance ensures patient safety and efficacy. They possess extensive experience in the pharmaceutical industry, with a global reach and a strong presence in key regions like Asia and North America. Their production lines are compliant with EU and US GMP standards, reflecting their dedication to quality and adherence to international best practices. Key therapy areas include oncology, cardiology, and other areas where biosimilars are widely used. They offer a variety of dosage forms including solids, liquids, and injectables. While specific product patents are not explicitly mentioned, their focus on innovation and research suggests they actively pursue intellectual property protection for their offerings.

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Gadobutrol Manufacturers

Markets of interest

Gadobutrol is a contrast agent with magnetic properties. The substance used in magnetic resonance imaging (MRI) in adults and children older than 2 years of age. Gadibutrol allows blood vessels, organs, and other non-bony tissues to be seen more clearly. The medication is used to help diagnose certain disorders of the brain and spine (central nervous system), the blood vessels of the kidneys, and the heart. The substance is also used with an MRI of the breast to help detect breast cancer. The substance is available for sale in the form of a pre-filled syringe, injection, from manufacturers in various countries including Y. The drug is provided by a wide range of Gadobutrol suppliers from various countries including the Y, Y, and Y. Mostly due to the availability of raw materials for the manufacturing process and low labor costs, the leading Gadobutrol manufacturers and distributors are based in China and North Korea.

Licensing and brand names

Gadobutrol was first approved for use in MRIs of the central nervous system in the United States in 2011. In 2015, the medication under the trade name Gadavist was approved by the FDA as the first contrast agent safe for use in children under the age of 2 years old. In early 2016, Gadavist was approved in the United States for use in contrast-enhanced magnetic resonance angiography. Under the trade names, Gadograf and Gadovist, the medication was approved by the EMA in the European Union in 2007. The medication is presently approved in many countries and is available in both generic and trade name versions. The medication is marketed under the trade names including Gadavist and Gadovist 1.0. One of the most popular branded versions of Gadobutrol is manufactured and supplied by the Chinese pharmaceutical company Ningbo distant chemicals co.,ltd. Other manufacturing companies and distributors from India and Germany have also successfully adapted to the demands of the global marketplace and produce a variant of the drug with Gadobutrol as an active ingredient.

Target supply price

The wholesale acquisition cost of Gadavist intravenous solution (604.72 mg/mL) is around $80 for a supply of 7.5 milliliters. The retail price of the same amount of the substance in Europe reaches €72.81 EUR. The medication wholesale prices and commercial terms can vary depending on the supplier. The medication wholesale prices and commercial terms can vary depending on the supplier.

Information from manufacturers

We provide a detailed list of the Gadobutrol manufacturers and suppliers that you are looking for. You can also find the dossier status of Gadobutrol and the GMP approvals of the different variants of the medication. The product description of all Gadobutrol suppliers contains essential information about the medication you order including clinical data, stability zones, and a list of countries where Gadobutrol is already registered in. Manufacturers also specify the commercial terms of their offers, such as the market for which the offer is intended, deal type, dossier licensing fee, supply price, payment terms as well as delivery terms. Buyers are advised that online sellers may attempt to market fraudulent versions of the generic drug, whereas Pipeline Pharma, through its pre-auditing and quality control procedures ensures that only verified Follicle-stimulating hormone suppliers and distributors enter our online marketplace, offering you a risk-free global B2B pharmaceutical sales platform.

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