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ABOUT THIS PAGE
A Cisapride Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cisapride Monohydrate, including repackagers and relabelers. The FDA regulates Cisapride Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cisapride Monohydrate 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 Cisapride Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cisapride Monohydrate supplier is an individual or a company that provides Cisapride Monohydrate active pharmaceutical ingredient (API) or Cisapride Monohydrate finished formulations upon request. The Cisapride Monohydrate suppliers may include Cisapride Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Cisapride Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cisapride Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Cisapride Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Cisapride Monohydrate DMFs exist exist since differing nations have different regulations, such as Cisapride Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cisapride Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Cisapride Monohydrate USDMF includes data on Cisapride Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cisapride Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cisapride Monohydrate suppliers with USDMF on PharmaCompass.
A Cisapride Monohydrate CEP of the European Pharmacopoeia monograph is often referred to as a Cisapride Monohydrate Certificate of Suitability (COS). The purpose of a Cisapride Monohydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cisapride Monohydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cisapride Monohydrate to their clients by showing that a Cisapride Monohydrate CEP has been issued for it. The manufacturer submits a Cisapride Monohydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cisapride Monohydrate CEP holder for the record. Additionally, the data presented in the Cisapride Monohydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cisapride Monohydrate DMF.
A Cisapride Monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cisapride Monohydrate 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 Cisapride Monohydrate suppliers with CEP (COS) on PharmaCompass.
A Cisapride Monohydrate written confirmation (Cisapride Monohydrate WC) is an official document issued by a regulatory agency to a Cisapride Monohydrate manufacturer, verifying that the manufacturing facility of a Cisapride Monohydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cisapride Monohydrate APIs or Cisapride Monohydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Cisapride Monohydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Cisapride Monohydrate 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 Cisapride Monohydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cisapride Monohydrate 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 Cisapride Monohydrate 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 Cisapride Monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cisapride Monohydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cisapride Monohydrate suppliers with NDC on PharmaCompass.
Cisapride Monohydrate 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 Cisapride Monohydrate 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 Cisapride Monohydrate GMP manufacturer or Cisapride Monohydrate GMP API supplier for your needs.
A Cisapride Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Cisapride Monohydrate's compliance with Cisapride Monohydrate specifications and serves as a tool for batch-level quality control.
Cisapride Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Cisapride Monohydrate 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.
Cisapride Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Cisapride Monohydrate EP), Cisapride Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cisapride Monohydrate USP).
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