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