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