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