US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Vitamin D3 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 Vitamin D3 manufacturer or Vitamin D3 supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vitamin D3 manufacturer or Vitamin D3 supplier.
PharmaCompass also assists you with knowing the Vitamin D3 API Price utilized in the formulation of products. Vitamin D3 API Price is not always fixed or binding as the Vitamin D3 Price is obtained through a variety of data sources. The Vitamin D3 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vitamin D3 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin D3, including repackagers and relabelers. The FDA regulates Vitamin D3 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin D3 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 Vitamin D3 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vitamin D3 supplier is an individual or a company that provides Vitamin D3 active pharmaceutical ingredient (API) or Vitamin D3 finished formulations upon request. The Vitamin D3 suppliers may include Vitamin D3 API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Vitamin D3 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vitamin D3 DMF (Drug Master File) is a document detailing the whole manufacturing process of Vitamin D3 active pharmaceutical ingredient (API) in detail. Different forms of Vitamin D3 DMFs exist exist since differing nations have different regulations, such as Vitamin D3 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vitamin D3 DMF submitted to regulatory agencies in the US is known as a USDMF. Vitamin D3 USDMF includes data on Vitamin D3's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vitamin D3 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Vitamin D3 Drug Master File in Japan (Vitamin D3 JDMF) empowers Vitamin D3 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 Vitamin D3 JDMF during the approval evaluation for pharmaceutical products. At the time of Vitamin D3 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 Vitamin D3 suppliers with JDMF on PharmaCompass.
A Vitamin D3 CEP of the European Pharmacopoeia monograph is often referred to as a Vitamin D3 Certificate of Suitability (COS). The purpose of a Vitamin D3 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vitamin D3 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vitamin D3 to their clients by showing that a Vitamin D3 CEP has been issued for it. The manufacturer submits a Vitamin D3 CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vitamin D3 CEP holder for the record. Additionally, the data presented in the Vitamin D3 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vitamin D3 DMF.
A Vitamin D3 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vitamin D3 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 Vitamin D3 suppliers with CEP (COS) on PharmaCompass.
A Vitamin D3 written confirmation (Vitamin D3 WC) is an official document issued by a regulatory agency to a Vitamin D3 manufacturer, verifying that the manufacturing facility of a Vitamin D3 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vitamin D3 APIs or Vitamin D3 finished pharmaceutical products to another nation, regulatory agencies frequently require a Vitamin D3 WC (written confirmation) as part of the regulatory process.
CLICK HERE to find a list of Vitamin D3 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 Vitamin D3 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vitamin D3 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 Vitamin D3 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 Vitamin D3 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vitamin D3 NDC to their finished compounded human drug products, they may choose to do so.
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Vitamin D3 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 Vitamin D3 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 Vitamin D3 GMP manufacturer or Vitamin D3 GMP API supplier for your needs.
A Vitamin D3 CoA (Certificate of Analysis) is a formal document that attests to Vitamin D3's compliance with Vitamin D3 specifications and serves as a tool for batch-level quality control.
Vitamin D3 CoA mostly includes findings from lab analyses of a specific batch. For each Vitamin D3 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.
Vitamin D3 may be tested according to a variety of international standards, such as European Pharmacopoeia (Vitamin D3 EP), Vitamin D3 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vitamin D3 USP).