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