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PharmaCompass offers a list of Eslicarbazepine 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 Eslicarbazepine Acetate manufacturer or Eslicarbazepine Acetate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eslicarbazepine Acetate manufacturer or Eslicarbazepine Acetate supplier.
PharmaCompass also assists you with knowing the Eslicarbazepine Acetate API Price utilized in the formulation of products. Eslicarbazepine Acetate API Price is not always fixed or binding as the Eslicarbazepine Acetate Price is obtained through a variety of data sources. The Eslicarbazepine Acetate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide, including repackagers and relabelers. The FDA regulates 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide supplier is an individual or a company that provides 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide active pharmaceutical ingredient (API) or 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide finished formulations upon request. The 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide suppliers may include 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide API manufacturers, exporters, distributors and traders.
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A 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide DMF (Drug Master File) is a document detailing the whole manufacturing process of 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide active pharmaceutical ingredient (API) in detail. Different forms of 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide DMFs exist exist since differing nations have different regulations, such as 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide DMF submitted to regulatory agencies in the US is known as a USDMF. 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide USDMF includes data on 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide 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 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide Drug Master File in Korea (10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide. The MFDS reviews the 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide KDMF as part of the drug registration process and uses the information provided in the 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide 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 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide API can apply through the Korea Drug Master File (KDMF).
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A 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide written confirmation (10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide WC) is an official document issued by a regulatory agency to a 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide manufacturer, verifying that the manufacturing facility of a 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide APIs or 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide finished pharmaceutical products to another nation, regulatory agencies frequently require a 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide WC (written confirmation) as part of the regulatory process.
click here to find a list of 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide suppliers with Written Confirmation (WC) 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 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide 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 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide 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 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide NDC to their finished compounded human drug products, they may choose to do so.
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10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide 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 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide 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 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide GMP manufacturer or 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide GMP API supplier for your needs.
A 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide CoA (Certificate of Analysis) is a formal document that attests to 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide's compliance with 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide specifications and serves as a tool for batch-level quality control.
10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide CoA mostly includes findings from lab analyses of a specific batch. For each 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide 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.
10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide may be tested according to a variety of international standards, such as European Pharmacopoeia (10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide EP), 10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (10-acetoxy-10,11-dihydro-5H-dibenz(b,f)azepine-5-carboxamide USP).
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