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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 Eslicarbazepine Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eslicarbazepine Acetate, including repackagers and relabelers. The FDA regulates Eslicarbazepine Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eslicarbazepine Acetate 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 Eslicarbazepine Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eslicarbazepine Acetate supplier is an individual or a company that provides Eslicarbazepine Acetate active pharmaceutical ingredient (API) or Eslicarbazepine Acetate finished formulations upon request. The Eslicarbazepine Acetate suppliers may include Eslicarbazepine Acetate API manufacturers, exporters, distributors and traders.
click here to find a list of Eslicarbazepine Acetate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eslicarbazepine Acetate DMF (Drug Master File) is a document detailing the whole manufacturing process of Eslicarbazepine Acetate active pharmaceutical ingredient (API) in detail. Different forms of Eslicarbazepine Acetate DMFs exist exist since differing nations have different regulations, such as Eslicarbazepine Acetate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eslicarbazepine Acetate DMF submitted to regulatory agencies in the US is known as a USDMF. Eslicarbazepine Acetate USDMF includes data on Eslicarbazepine Acetate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eslicarbazepine Acetate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eslicarbazepine Acetate 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 Eslicarbazepine Acetate Drug Master File in Korea (Eslicarbazepine Acetate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eslicarbazepine Acetate. The MFDS reviews the Eslicarbazepine Acetate KDMF as part of the drug registration process and uses the information provided in the Eslicarbazepine Acetate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eslicarbazepine Acetate 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 Eslicarbazepine Acetate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eslicarbazepine Acetate suppliers with KDMF on PharmaCompass.
A Eslicarbazepine Acetate written confirmation (Eslicarbazepine Acetate WC) is an official document issued by a regulatory agency to a Eslicarbazepine Acetate manufacturer, verifying that the manufacturing facility of a Eslicarbazepine Acetate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eslicarbazepine Acetate APIs or Eslicarbazepine Acetate finished pharmaceutical products to another nation, regulatory agencies frequently require a Eslicarbazepine Acetate WC (written confirmation) as part of the regulatory process.
click here to find a list of Eslicarbazepine Acetate 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 Eslicarbazepine Acetate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eslicarbazepine Acetate 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 Eslicarbazepine Acetate 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 Eslicarbazepine Acetate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eslicarbazepine Acetate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eslicarbazepine Acetate suppliers with NDC on PharmaCompass.
Eslicarbazepine Acetate 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 Eslicarbazepine Acetate 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 Eslicarbazepine Acetate GMP manufacturer or Eslicarbazepine Acetate GMP API supplier for your needs.
A Eslicarbazepine Acetate CoA (Certificate of Analysis) is a formal document that attests to Eslicarbazepine Acetate's compliance with Eslicarbazepine Acetate specifications and serves as a tool for batch-level quality control.
Eslicarbazepine Acetate CoA mostly includes findings from lab analyses of a specific batch. For each Eslicarbazepine Acetate 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.
Eslicarbazepine Acetate may be tested according to a variety of international standards, such as European Pharmacopoeia (Eslicarbazepine Acetate EP), Eslicarbazepine Acetate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eslicarbazepine Acetate USP).
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