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PharmaCompass offers a list of Fludrocortisone Acetate 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 Fludrocortisone Acetate manufacturer or Fludrocortisone Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fludrocortisone Acetate manufacturer or Fludrocortisone Acetate supplier.
PharmaCompass also assists you with knowing the Fludrocortisone Acetate API Price utilized in the formulation of products. Fludrocortisone Acetate API Price is not always fixed or binding as the Fludrocortisone Acetate Price is obtained through a variety of data sources. The Fludrocortisone Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate, including repackagers and relabelers. The FDA regulates (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate 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 (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate supplier is an individual or a company that provides (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate active pharmaceutical ingredient (API) or (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate finished formulations upon request. The (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate suppliers may include (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate API manufacturers, exporters, distributors and traders.
click here to find a list of (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate active pharmaceutical ingredient (API) in detail. Different forms of (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate DMFs exist exist since differing nations have different regulations, such as (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate DMF submitted to regulatory agencies in the US is known as a USDMF. (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate USDMF includes data on (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate Drug Master File in Korea ((11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate. The MFDS reviews the (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate KDMF as part of the drug registration process and uses the information provided in the (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate 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 (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate API can apply through the Korea Drug Master File (KDMF).
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A (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate CEP of the European Pharmacopoeia monograph is often referred to as a (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate Certificate of Suitability (COS). The purpose of a (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate to their clients by showing that a (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate CEP has been issued for it. The manufacturer submits a (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate CEP (COS) as part of the market authorization procedure, and it takes on the role of a (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate CEP holder for the record. Additionally, the data presented in the (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate DMF.
A (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate 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 (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate written confirmation ((11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate WC) is an official document issued by a regulatory agency to a (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate manufacturer, verifying that the manufacturing facility of a (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate APIs or (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate 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 (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate 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 (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate 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 (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate NDC to their finished compounded human drug products, they may choose to do so.
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(11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate 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 (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate 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 (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate GMP manufacturer or (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate GMP API supplier for your needs.
A (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate CoA (Certificate of Analysis) is a formal document that attests to (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate's compliance with (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate specifications and serves as a tool for batch-level quality control.
(11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate CoA mostly includes findings from lab analyses of a specific batch. For each (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate 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.
(11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate may be tested according to a variety of international standards, such as European Pharmacopoeia ((11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate EP), (11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((11beta)-9-fluoro-11,17-dihydroxy-3,20-dioxopregn-4-en-21-yl acetate USP).