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