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