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ABOUT THIS PAGE
A Xipamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xipamide, including repackagers and relabelers. The FDA regulates Xipamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xipamide 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 Xipamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xipamide supplier is an individual or a company that provides Xipamide active pharmaceutical ingredient (API) or Xipamide finished formulations upon request. The Xipamide suppliers may include Xipamide API manufacturers, exporters, distributors and traders.
click here to find a list of Xipamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Xipamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Xipamide active pharmaceutical ingredient (API) in detail. Different forms of Xipamide DMFs exist exist since differing nations have different regulations, such as Xipamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xipamide DMF submitted to regulatory agencies in the US is known as a USDMF. Xipamide USDMF includes data on Xipamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xipamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Xipamide suppliers with USDMF on PharmaCompass.
A Xipamide written confirmation (Xipamide WC) is an official document issued by a regulatory agency to a Xipamide manufacturer, verifying that the manufacturing facility of a Xipamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Xipamide APIs or Xipamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Xipamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Xipamide suppliers with Written Confirmation (WC) on PharmaCompass.
Xipamide 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 Xipamide 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 Xipamide GMP manufacturer or Xipamide GMP API supplier for your needs.
A Xipamide CoA (Certificate of Analysis) is a formal document that attests to Xipamide's compliance with Xipamide specifications and serves as a tool for batch-level quality control.
Xipamide CoA mostly includes findings from lab analyses of a specific batch. For each Xipamide 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.
Xipamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Xipamide EP), Xipamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Xipamide USP).
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