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