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