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