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API SUPPLIERS
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Flubendazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flubendazole, including repackagers and relabelers. The FDA regulates Flubendazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flubendazole 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 Flubendazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flubendazole supplier is an individual or a company that provides Flubendazole active pharmaceutical ingredient (API) or Flubendazole finished formulations upon request. The Flubendazole suppliers may include Flubendazole API manufacturers, exporters, distributors and traders.
click here to find a list of Flubendazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flubendazole CEP of the European Pharmacopoeia monograph is often referred to as a Flubendazole Certificate of Suitability (COS). The purpose of a Flubendazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Flubendazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Flubendazole to their clients by showing that a Flubendazole CEP has been issued for it. The manufacturer submits a Flubendazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Flubendazole CEP holder for the record. Additionally, the data presented in the Flubendazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Flubendazole DMF.
A Flubendazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Flubendazole 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 Flubendazole suppliers with CEP (COS) 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 Flubendazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Flubendazole 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 Flubendazole 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 Flubendazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Flubendazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Flubendazole suppliers with NDC on PharmaCompass.
Flubendazole 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 Flubendazole 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 Flubendazole GMP manufacturer or Flubendazole GMP API supplier for your needs.
A Flubendazole CoA (Certificate of Analysis) is a formal document that attests to Flubendazole's compliance with Flubendazole specifications and serves as a tool for batch-level quality control.
Flubendazole CoA mostly includes findings from lab analyses of a specific batch. For each Flubendazole 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.
Flubendazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Flubendazole EP), Flubendazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Flubendazole USP).
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