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DOSAGE - CREAM;TOPICAL - 0.05% **Federal Regi...DOSAGE - CREAM;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16908
DOSAGE - OINTMENT;TOPICAL - 0.05% **Federal R...DOSAGE - OINTMENT;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 16909
DOSAGE - SOLUTION;TOPICAL - 0.05% **Federal R...DOSAGE - SOLUTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18849
DOSAGE - CREAM;TOPICAL - 0.05% **Federal Regi...DOSAGE - CREAM;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19117
DOSAGE - CREAM;TOPICAL - 0.1%
USFDA APPLICATION NUMBER - 21758
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ABOUT THIS PAGE
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PharmaCompass offers a list of Fluocinonide 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 Fluocinonide manufacturer or Fluocinonide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluocinonide manufacturer or Fluocinonide supplier.
PharmaCompass also assists you with knowing the Fluocinonide API Price utilized in the formulation of products. Fluocinonide API Price is not always fixed or binding as the Fluocinonide Price is obtained through a variety of data sources. The Fluocinonide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fluocinolide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluocinolide, including repackagers and relabelers. The FDA regulates Fluocinolide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluocinolide 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 Fluocinolide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluocinolide supplier is an individual or a company that provides Fluocinolide active pharmaceutical ingredient (API) or Fluocinolide finished formulations upon request. The Fluocinolide suppliers may include Fluocinolide API manufacturers, exporters, distributors and traders.
click here to find a list of Fluocinolide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fluocinolide DMF (Drug Master File) is a document detailing the whole manufacturing process of Fluocinolide active pharmaceutical ingredient (API) in detail. Different forms of Fluocinolide DMFs exist exist since differing nations have different regulations, such as Fluocinolide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fluocinolide DMF submitted to regulatory agencies in the US is known as a USDMF. Fluocinolide USDMF includes data on Fluocinolide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fluocinolide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fluocinolide 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 Fluocinolide Drug Master File in Japan (Fluocinolide JDMF) empowers Fluocinolide 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 Fluocinolide JDMF during the approval evaluation for pharmaceutical products. At the time of Fluocinolide 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 Fluocinolide 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 Fluocinolide Drug Master File in Korea (Fluocinolide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fluocinolide. The MFDS reviews the Fluocinolide KDMF as part of the drug registration process and uses the information provided in the Fluocinolide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fluocinolide 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 Fluocinolide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fluocinolide suppliers with KDMF 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 Fluocinolide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fluocinolide 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 Fluocinolide 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 Fluocinolide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fluocinolide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fluocinolide suppliers with NDC on PharmaCompass.
Fluocinolide 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 Fluocinolide 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 Fluocinolide GMP manufacturer or Fluocinolide GMP API supplier for your needs.
A Fluocinolide CoA (Certificate of Analysis) is a formal document that attests to Fluocinolide's compliance with Fluocinolide specifications and serves as a tool for batch-level quality control.
Fluocinolide CoA mostly includes findings from lab analyses of a specific batch. For each Fluocinolide 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.
Fluocinolide may be tested according to a variety of international standards, such as European Pharmacopoeia (Fluocinolide EP), Fluocinolide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fluocinolide USP).
