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API SUPPLIERS
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USDMF
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ABOUT THIS PAGE
A Flutrimazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flutrimazole, including repackagers and relabelers. The FDA regulates Flutrimazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flutrimazole 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 Flutrimazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flutrimazole supplier is an individual or a company that provides Flutrimazole active pharmaceutical ingredient (API) or Flutrimazole finished formulations upon request. The Flutrimazole suppliers may include Flutrimazole API manufacturers, exporters, distributors and traders.
click here to find a list of Flutrimazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flutrimazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Flutrimazole active pharmaceutical ingredient (API) in detail. Different forms of Flutrimazole DMFs exist exist since differing nations have different regulations, such as Flutrimazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flutrimazole DMF submitted to regulatory agencies in the US is known as a USDMF. Flutrimazole USDMF includes data on Flutrimazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flutrimazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flutrimazole suppliers with USDMF 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 Flutrimazole Drug Master File in Korea (Flutrimazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Flutrimazole. The MFDS reviews the Flutrimazole KDMF as part of the drug registration process and uses the information provided in the Flutrimazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Flutrimazole 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 Flutrimazole API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Flutrimazole suppliers with KDMF on PharmaCompass.
A Flutrimazole CEP of the European Pharmacopoeia monograph is often referred to as a Flutrimazole Certificate of Suitability (COS). The purpose of a Flutrimazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Flutrimazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Flutrimazole to their clients by showing that a Flutrimazole CEP has been issued for it. The manufacturer submits a Flutrimazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Flutrimazole CEP holder for the record. Additionally, the data presented in the Flutrimazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Flutrimazole DMF.
A Flutrimazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Flutrimazole 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 Flutrimazole suppliers with CEP (COS) on PharmaCompass.
Flutrimazole 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 Flutrimazole 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 Flutrimazole GMP manufacturer or Flutrimazole GMP API supplier for your needs.
A Flutrimazole CoA (Certificate of Analysis) is a formal document that attests to Flutrimazole's compliance with Flutrimazole specifications and serves as a tool for batch-level quality control.
Flutrimazole CoA mostly includes findings from lab analyses of a specific batch. For each Flutrimazole 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.
Flutrimazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Flutrimazole EP), Flutrimazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Flutrimazole USP).
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