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ABOUT THIS PAGE
A Iso-Sulfan Blue manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iso-Sulfan Blue, including repackagers and relabelers. The FDA regulates Iso-Sulfan Blue manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iso-Sulfan Blue 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 Iso-Sulfan Blue manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iso-Sulfan Blue supplier is an individual or a company that provides Iso-Sulfan Blue active pharmaceutical ingredient (API) or Iso-Sulfan Blue finished formulations upon request. The Iso-Sulfan Blue suppliers may include Iso-Sulfan Blue API manufacturers, exporters, distributors and traders.
click here to find a list of Iso-Sulfan Blue suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Iso-Sulfan Blue DMF (Drug Master File) is a document detailing the whole manufacturing process of Iso-Sulfan Blue active pharmaceutical ingredient (API) in detail. Different forms of Iso-Sulfan Blue DMFs exist exist since differing nations have different regulations, such as Iso-Sulfan Blue USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Iso-Sulfan Blue DMF submitted to regulatory agencies in the US is known as a USDMF. Iso-Sulfan Blue USDMF includes data on Iso-Sulfan Blue's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Iso-Sulfan Blue USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Iso-Sulfan Blue suppliers with USDMF on PharmaCompass.
A Iso-Sulfan Blue written confirmation (Iso-Sulfan Blue WC) is an official document issued by a regulatory agency to a Iso-Sulfan Blue manufacturer, verifying that the manufacturing facility of a Iso-Sulfan Blue active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Iso-Sulfan Blue APIs or Iso-Sulfan Blue finished pharmaceutical products to another nation, regulatory agencies frequently require a Iso-Sulfan Blue WC (written confirmation) as part of the regulatory process.
click here to find a list of Iso-Sulfan Blue suppliers with Written Confirmation (WC) 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 Iso-Sulfan Blue as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Iso-Sulfan Blue 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 Iso-Sulfan Blue 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 Iso-Sulfan Blue and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Iso-Sulfan Blue NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Iso-Sulfan Blue suppliers with NDC on PharmaCompass.
Iso-Sulfan Blue 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 Iso-Sulfan Blue 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 Iso-Sulfan Blue GMP manufacturer or Iso-Sulfan Blue GMP API supplier for your needs.
A Iso-Sulfan Blue CoA (Certificate of Analysis) is a formal document that attests to Iso-Sulfan Blue's compliance with Iso-Sulfan Blue specifications and serves as a tool for batch-level quality control.
Iso-Sulfan Blue CoA mostly includes findings from lab analyses of a specific batch. For each Iso-Sulfan Blue 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.
Iso-Sulfan Blue may be tested according to a variety of international standards, such as European Pharmacopoeia (Iso-Sulfan Blue EP), Iso-Sulfan Blue JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Iso-Sulfan Blue USP).
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