US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Calcipotriol 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 Calcipotriol manufacturer or Calcipotriol supplier for your needs.
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PharmaCompass also assists you with knowing the Calcipotriol API Price utilized in the formulation of products. Calcipotriol API Price is not always fixed or binding as the Calcipotriol Price is obtained through a variety of data sources. The Calcipotriol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Calcipotriene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcipotriene, including repackagers and relabelers. The FDA regulates Calcipotriene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcipotriene 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 Calcipotriene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcipotriene supplier is an individual or a company that provides Calcipotriene active pharmaceutical ingredient (API) or Calcipotriene finished formulations upon request. The Calcipotriene suppliers may include Calcipotriene API manufacturers, exporters, distributors and traders.
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A Calcipotriene DMF (Drug Master File) is a document detailing the whole manufacturing process of Calcipotriene active pharmaceutical ingredient (API) in detail. Different forms of Calcipotriene DMFs exist exist since differing nations have different regulations, such as Calcipotriene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calcipotriene DMF submitted to regulatory agencies in the US is known as a USDMF. Calcipotriene USDMF includes data on Calcipotriene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calcipotriene 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 Calcipotriene Drug Master File in Japan (Calcipotriene JDMF) empowers Calcipotriene 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 Calcipotriene JDMF during the approval evaluation for pharmaceutical products. At the time of Calcipotriene JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Calcipotriene Drug Master File in Korea (Calcipotriene KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calcipotriene. The MFDS reviews the Calcipotriene KDMF as part of the drug registration process and uses the information provided in the Calcipotriene KDMF to evaluate the safety and efficacy of the drug.
After submitting a Calcipotriene KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Calcipotriene API can apply through the Korea Drug Master File (KDMF).
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A Calcipotriene CEP of the European Pharmacopoeia monograph is often referred to as a Calcipotriene Certificate of Suitability (COS). The purpose of a Calcipotriene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcipotriene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcipotriene to their clients by showing that a Calcipotriene CEP has been issued for it. The manufacturer submits a Calcipotriene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcipotriene CEP holder for the record. Additionally, the data presented in the Calcipotriene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcipotriene DMF.
A Calcipotriene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcipotriene CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Calcipotriene written confirmation (Calcipotriene WC) is an official document issued by a regulatory agency to a Calcipotriene manufacturer, verifying that the manufacturing facility of a Calcipotriene active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Calcipotriene APIs or Calcipotriene finished pharmaceutical products to another nation, regulatory agencies frequently require a Calcipotriene WC (written confirmation) as part of the regulatory process.
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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 Calcipotriene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Calcipotriene 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 Calcipotriene 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 Calcipotriene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calcipotriene NDC to their finished compounded human drug products, they may choose to do so.
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Calcipotriene 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 Calcipotriene 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 Calcipotriene GMP manufacturer or Calcipotriene GMP API supplier for your needs.
A Calcipotriene CoA (Certificate of Analysis) is a formal document that attests to Calcipotriene's compliance with Calcipotriene specifications and serves as a tool for batch-level quality control.
Calcipotriene CoA mostly includes findings from lab analyses of a specific batch. For each Calcipotriene 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.
Calcipotriene may be tested according to a variety of international standards, such as European Pharmacopoeia (Calcipotriene EP), Calcipotriene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calcipotriene USP).