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