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