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