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