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Looking for 92339-11-2 / Iodixanol API manufacturers, exporters & distributors?

Iodixanol manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Iodixanol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Iodixanol manufacturer or Iodixanol supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Iodixanol manufacturer or Iodixanol supplier.

PharmaCompass also assists you with knowing the Iodixanol API Price utilized in the formulation of products. Iodixanol API Price is not always fixed or binding as the Iodixanol Price is obtained through a variety of data sources. The Iodixanol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Iodixanol

Synonyms

92339-11-2, Visipaque, Indixanol, Iodixanolum, 2-5410-3a, Hw8w27htxx

Cas Number

92339-11-2

Unique Ingredient Identifier (UNII)

HW8W27HTXX

About Iodixanol

Iodixanol is a dimeric iso-osmolar, non-ionic, hydrophilic iodinated radiocontrast agent used in diagnostic imaging. Upon intravascular administration and during computed tomography (CT) imaging, iodixanol blocks x-rays and appears opaque on x-ray images. This allows body structures that absorb iodine to be visualized. The degree of opacity produced by iodixanol is directly proportional to the total amount of the iodinated contrast agent in the path of the x-rays. The visualization of body structures is dependent upon the distribution and elimination of iodixanol. Compared to other iodinated contrast agents, iodixanol appears to exhibit less nephrotoxicity.

Prestwick3_000848 Manufacturers

A Prestwick3_000848 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prestwick3_000848, including repackagers and relabelers. The FDA regulates Prestwick3_000848 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prestwick3_000848 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Prestwick3_000848 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Prestwick3_000848 Suppliers

A Prestwick3_000848 supplier is an individual or a company that provides Prestwick3_000848 active pharmaceutical ingredient (API) or Prestwick3_000848 finished formulations upon request. The Prestwick3_000848 suppliers may include Prestwick3_000848 API manufacturers, exporters, distributors and traders.

click here to find a list of Prestwick3_000848 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Prestwick3_000848 USDMF

A Prestwick3_000848 DMF (Drug Master File) is a document detailing the whole manufacturing process of Prestwick3_000848 active pharmaceutical ingredient (API) in detail. Different forms of Prestwick3_000848 DMFs exist exist since differing nations have different regulations, such as Prestwick3_000848 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Prestwick3_000848 DMF submitted to regulatory agencies in the US is known as a USDMF. Prestwick3_000848 USDMF includes data on Prestwick3_000848's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prestwick3_000848 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Prestwick3_000848 suppliers with USDMF on PharmaCompass.

Prestwick3_000848 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Prestwick3_000848 Drug Master File in Japan (Prestwick3_000848 JDMF) empowers Prestwick3_000848 API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Prestwick3_000848 JDMF during the approval evaluation for pharmaceutical products. At the time of Prestwick3_000848 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Prestwick3_000848 suppliers with JDMF on PharmaCompass.

Prestwick3_000848 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Prestwick3_000848 Drug Master File in Korea (Prestwick3_000848 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Prestwick3_000848. The MFDS reviews the Prestwick3_000848 KDMF as part of the drug registration process and uses the information provided in the Prestwick3_000848 KDMF to evaluate the safety and efficacy of the drug.

After submitting a Prestwick3_000848 KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Prestwick3_000848 API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Prestwick3_000848 suppliers with KDMF on PharmaCompass.

Prestwick3_000848 CEP

A Prestwick3_000848 CEP of the European Pharmacopoeia monograph is often referred to as a Prestwick3_000848 Certificate of Suitability (COS). The purpose of a Prestwick3_000848 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prestwick3_000848 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prestwick3_000848 to their clients by showing that a Prestwick3_000848 CEP has been issued for it. The manufacturer submits a Prestwick3_000848 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prestwick3_000848 CEP holder for the record. Additionally, the data presented in the Prestwick3_000848 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prestwick3_000848 DMF.

A Prestwick3_000848 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prestwick3_000848 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Prestwick3_000848 suppliers with CEP (COS) on PharmaCompass.

Prestwick3_000848 NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Prestwick3_000848 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Prestwick3_000848 API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Prestwick3_000848 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Prestwick3_000848 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prestwick3_000848 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Prestwick3_000848 suppliers with NDC on PharmaCompass.

Prestwick3_000848 GMP

Prestwick3_000848 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Prestwick3_000848 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Prestwick3_000848 GMP manufacturer or Prestwick3_000848 GMP API supplier for your needs.

Prestwick3_000848 CoA

A Prestwick3_000848 CoA (Certificate of Analysis) is a formal document that attests to Prestwick3_000848's compliance with Prestwick3_000848 specifications and serves as a tool for batch-level quality control.

Prestwick3_000848 CoA mostly includes findings from lab analyses of a specific batch. For each Prestwick3_000848 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Prestwick3_000848 may be tested according to a variety of international standards, such as European Pharmacopoeia (Prestwick3_000848 EP), Prestwick3_000848 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prestwick3_000848 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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