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