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PharmaCompass offers a list of Ziprasidone Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ziprasidone Hydrochloride manufacturer or Ziprasidone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ziprasidone Hydrochloride manufacturer or Ziprasidone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ziprasidone Hydrochloride API Price utilized in the formulation of products. Ziprasidone Hydrochloride API Price is not always fixed or binding as the Ziprasidone Hydrochloride Price is obtained through a variety of data sources. The Ziprasidone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ziprasidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ziprasidone, including repackagers and relabelers. The FDA regulates Ziprasidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ziprasidone 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ziprasidone supplier is an individual or a company that provides Ziprasidone active pharmaceutical ingredient (API) or Ziprasidone finished formulations upon request. The Ziprasidone suppliers may include Ziprasidone API manufacturers, exporters, distributors and traders.
click here to find a list of Ziprasidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ziprasidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Ziprasidone active pharmaceutical ingredient (API) in detail. Different forms of Ziprasidone DMFs exist exist since differing nations have different regulations, such as Ziprasidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ziprasidone DMF submitted to regulatory agencies in the US is known as a USDMF. Ziprasidone USDMF includes data on Ziprasidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ziprasidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ziprasidone suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ziprasidone Drug Master File in Korea (Ziprasidone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ziprasidone. The MFDS reviews the Ziprasidone KDMF as part of the drug registration process and uses the information provided in the Ziprasidone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ziprasidone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ziprasidone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ziprasidone suppliers with KDMF on PharmaCompass.
A Ziprasidone CEP of the European Pharmacopoeia monograph is often referred to as a Ziprasidone Certificate of Suitability (COS). The purpose of a Ziprasidone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ziprasidone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ziprasidone to their clients by showing that a Ziprasidone CEP has been issued for it. The manufacturer submits a Ziprasidone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ziprasidone CEP holder for the record. Additionally, the data presented in the Ziprasidone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ziprasidone DMF.
A Ziprasidone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ziprasidone 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 Ziprasidone suppliers with CEP (COS) on PharmaCompass.
A Ziprasidone written confirmation (Ziprasidone WC) is an official document issued by a regulatory agency to a Ziprasidone manufacturer, verifying that the manufacturing facility of a Ziprasidone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ziprasidone APIs or Ziprasidone finished pharmaceutical products to another nation, regulatory agencies frequently require a Ziprasidone WC (written confirmation) as part of the regulatory process.
click here to find a list of Ziprasidone 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ziprasidone 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ziprasidone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ziprasidone suppliers with NDC on PharmaCompass.
Ziprasidone 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 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 GMP manufacturer or Ziprasidone GMP API supplier for your needs.
A Ziprasidone CoA (Certificate of Analysis) is a formal document that attests to Ziprasidone's compliance with Ziprasidone specifications and serves as a tool for batch-level quality control.
Ziprasidone CoA mostly includes findings from lab analyses of a specific batch. For each Ziprasidone 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Ziprasidone EP), Ziprasidone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ziprasidone USP).
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