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JDMF
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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - EQ 10MG BASE
USFDA APPLICATION NUMBER - 20822
DOSAGE - TABLET;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 20822
DOSAGE - TABLET;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 20822
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EUROAPI
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Huzhou Sunflower Pharmaceutical
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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ABOUT THIS PAGE
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PharmaCompass offers a list of Citalopram Hydrobromide 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 Citalopram Hydrobromide manufacturer or Citalopram Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Citalopram Hydrobromide manufacturer or Citalopram Hydrobromide supplier.
PharmaCompass also assists you with knowing the Citalopram Hydrobromide API Price utilized in the formulation of products. Citalopram Hydrobromide API Price is not always fixed or binding as the Citalopram Hydrobromide Price is obtained through a variety of data sources. The Citalopram Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Prisdal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prisdal, including repackagers and relabelers. The FDA regulates Prisdal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prisdal 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 Prisdal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prisdal supplier is an individual or a company that provides Prisdal active pharmaceutical ingredient (API) or Prisdal finished formulations upon request. The Prisdal suppliers may include Prisdal API manufacturers, exporters, distributors and traders.
click here to find a list of Prisdal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prisdal DMF (Drug Master File) is a document detailing the whole manufacturing process of Prisdal active pharmaceutical ingredient (API) in detail. Different forms of Prisdal DMFs exist exist since differing nations have different regulations, such as Prisdal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prisdal DMF submitted to regulatory agencies in the US is known as a USDMF. Prisdal USDMF includes data on Prisdal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prisdal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prisdal suppliers with USDMF on PharmaCompass.
A Prisdal CEP of the European Pharmacopoeia monograph is often referred to as a Prisdal Certificate of Suitability (COS). The purpose of a Prisdal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prisdal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prisdal to their clients by showing that a Prisdal CEP has been issued for it. The manufacturer submits a Prisdal CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prisdal CEP holder for the record. Additionally, the data presented in the Prisdal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prisdal DMF.
A Prisdal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prisdal 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 Prisdal suppliers with CEP (COS) on PharmaCompass.
A Prisdal written confirmation (Prisdal WC) is an official document issued by a regulatory agency to a Prisdal manufacturer, verifying that the manufacturing facility of a Prisdal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prisdal APIs or Prisdal finished pharmaceutical products to another nation, regulatory agencies frequently require a Prisdal WC (written confirmation) as part of the regulatory process.
click here to find a list of Prisdal 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 Prisdal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prisdal 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 Prisdal 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 Prisdal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prisdal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prisdal suppliers with NDC on PharmaCompass.
Prisdal 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 Prisdal 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 Prisdal GMP manufacturer or Prisdal GMP API supplier for your needs.
A Prisdal CoA (Certificate of Analysis) is a formal document that attests to Prisdal's compliance with Prisdal specifications and serves as a tool for batch-level quality control.
Prisdal CoA mostly includes findings from lab analyses of a specific batch. For each Prisdal 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.
Prisdal may be tested according to a variety of international standards, such as European Pharmacopoeia (Prisdal EP), Prisdal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prisdal USP).
