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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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PharmaCompass offers a list of Iohexol 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 Iohexol manufacturer or Iohexol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Iohexol manufacturer or Iohexol supplier.
PharmaCompass also assists you with knowing the Iohexol API Price utilized in the formulation of products. Iohexol API Price is not always fixed or binding as the Iohexol Price is obtained through a variety of data sources. The Iohexol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Iohexol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iohexol, including repackagers and relabelers. The FDA regulates Iohexol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iohexol 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 Iohexol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iohexol supplier is an individual or a company that provides Iohexol active pharmaceutical ingredient (API) or Iohexol finished formulations upon request. The Iohexol suppliers may include Iohexol API manufacturers, exporters, distributors and traders.
click here to find a list of Iohexol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iohexol DMF (Drug Master File) is a document detailing the whole manufacturing process of Iohexol active pharmaceutical ingredient (API) in detail. Different forms of Iohexol DMFs exist exist since differing nations have different regulations, such as Iohexol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iohexol DMF submitted to regulatory agencies in the US is known as a USDMF. Iohexol USDMF includes data on Iohexol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iohexol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iohexol suppliers with USDMF on PharmaCompass.
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 Iohexol Drug Master File in Japan (Iohexol JDMF) empowers Iohexol 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 Iohexol JDMF during the approval evaluation for pharmaceutical products. At the time of Iohexol 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 Iohexol suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Iohexol Drug Master File in Korea (Iohexol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Iohexol. The MFDS reviews the Iohexol KDMF as part of the drug registration process and uses the information provided in the Iohexol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Iohexol 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 Iohexol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Iohexol suppliers with KDMF on PharmaCompass.
A Iohexol CEP of the European Pharmacopoeia monograph is often referred to as a Iohexol Certificate of Suitability (COS). The purpose of a Iohexol CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Iohexol EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Iohexol to their clients by showing that a Iohexol CEP has been issued for it. The manufacturer submits a Iohexol CEP (COS) as part of the market authorization procedure, and it takes on the role of a Iohexol CEP holder for the record. Additionally, the data presented in the Iohexol CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Iohexol DMF.
A Iohexol CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Iohexol 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 Iohexol suppliers with CEP (COS) on PharmaCompass.
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 Iohexol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Iohexol API and other APIs are published in this directory by the FDA.
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 Iohexol 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.
The NDC directory also contains data on finished compounded human drug products that contain Iohexol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Iohexol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Iohexol suppliers with NDC on PharmaCompass.
Iohexol 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 Iohexol 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 Iohexol GMP manufacturer or Iohexol GMP API supplier for your needs.
A Iohexol CoA (Certificate of Analysis) is a formal document that attests to Iohexol's compliance with Iohexol specifications and serves as a tool for batch-level quality control.
Iohexol CoA mostly includes findings from lab analyses of a specific batch. For each Iohexol 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.
Iohexol may be tested according to a variety of international standards, such as European Pharmacopoeia (Iohexol EP), Iohexol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Iohexol USP).
