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PharmaCompass offers a list of Citric Acid 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 Citric Acid manufacturer or Citric Acid supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Citric Acid manufacturer or Citric Acid supplier.
PharmaCompass also assists you with knowing the Citric Acid API Price utilized in the formulation of products. Citric Acid API Price is not always fixed or binding as the Citric Acid Price is obtained through a variety of data sources. The Citric Acid Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Citrate, including repackagers and relabelers. The FDA regulates Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Citrate 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 Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Citrate supplier is an individual or a company that provides Citrate active pharmaceutical ingredient (API) or Citrate finished formulations upon request. The Citrate suppliers may include Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Citrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Citrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Citrate active pharmaceutical ingredient (API) in detail. Different forms of Citrate DMFs exist exist since differing nations have different regulations, such as Citrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Citrate DMF submitted to regulatory agencies in the US is known as a USDMF. Citrate USDMF includes data on Citrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Citrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Citrate suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Citrate Drug Master File in Japan (Citrate JDMF) empowers Citrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Citrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Citrate suppliers with JDMF on PharmaCompass.
A Citrate CEP of the European Pharmacopoeia monograph is often referred to as a Citrate Certificate of Suitability (COS). The purpose of a Citrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Citrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Citrate to their clients by showing that a Citrate CEP has been issued for it. The manufacturer submits a Citrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Citrate CEP holder for the record. Additionally, the data presented in the Citrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Citrate DMF.
A Citrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Citrate 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 Citrate suppliers with CEP (COS) 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 Citrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Citrate 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 Citrate 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 Citrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Citrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Citrate suppliers with NDC on PharmaCompass.
Citrate 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 Citrate 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 Citrate GMP manufacturer or Citrate GMP API supplier for your needs.
A Citrate CoA (Certificate of Analysis) is a formal document that attests to Citrate's compliance with Citrate specifications and serves as a tool for batch-level quality control.
Citrate CoA mostly includes findings from lab analyses of a specific batch. For each Citrate 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.
Citrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Citrate EP), Citrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Citrate USP).