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