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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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API Imports and Exports
INTERMEDIATE SUPPLIERS
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DOSAGE - TABLET;ORAL - EQ 20MG BASE
USFDA APPLICATION NUMBER - 21016
DOSAGE - TABLET;ORAL - EQ 40MG BASE
USFDA APPLICATION NUMBER - 21016
Related Excipient Companies
Rochem International Inc
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
71
PharmaCompass offers a list of Eletriptan Hydrobromide 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 Eletriptan Hydrobromide manufacturer or Eletriptan Hydrobromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eletriptan Hydrobromide manufacturer or Eletriptan Hydrobromide supplier.
PharmaCompass also assists you with knowing the Eletriptan Hydrobromide API Price utilized in the formulation of products. Eletriptan Hydrobromide API Price is not always fixed or binding as the Eletriptan Hydrobromide Price is obtained through a variety of data sources. The Eletriptan Hydrobromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eletriptan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eletriptan, including repackagers and relabelers. The FDA regulates Eletriptan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eletriptan 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 Eletriptan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eletriptan supplier is an individual or a company that provides Eletriptan active pharmaceutical ingredient (API) or Eletriptan finished formulations upon request. The Eletriptan suppliers may include Eletriptan API manufacturers, exporters, distributors and traders.
click here to find a list of Eletriptan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eletriptan DMF (Drug Master File) is a document detailing the whole manufacturing process of Eletriptan active pharmaceutical ingredient (API) in detail. Different forms of Eletriptan DMFs exist exist since differing nations have different regulations, such as Eletriptan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eletriptan DMF submitted to regulatory agencies in the US is known as a USDMF. Eletriptan USDMF includes data on Eletriptan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eletriptan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eletriptan 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 Eletriptan Drug Master File in Japan (Eletriptan JDMF) empowers Eletriptan 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 Eletriptan JDMF during the approval evaluation for pharmaceutical products. At the time of Eletriptan 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 Eletriptan 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 Eletriptan Drug Master File in Korea (Eletriptan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eletriptan. The MFDS reviews the Eletriptan KDMF as part of the drug registration process and uses the information provided in the Eletriptan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eletriptan 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 Eletriptan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eletriptan suppliers with KDMF on PharmaCompass.
A Eletriptan written confirmation (Eletriptan WC) is an official document issued by a regulatory agency to a Eletriptan manufacturer, verifying that the manufacturing facility of a Eletriptan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eletriptan APIs or Eletriptan finished pharmaceutical products to another nation, regulatory agencies frequently require a Eletriptan WC (written confirmation) as part of the regulatory process.
click here to find a list of Eletriptan 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 Eletriptan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eletriptan 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 Eletriptan 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 Eletriptan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eletriptan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eletriptan suppliers with NDC on PharmaCompass.
Eletriptan 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 Eletriptan 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 Eletriptan GMP manufacturer or Eletriptan GMP API supplier for your needs.
A Eletriptan CoA (Certificate of Analysis) is a formal document that attests to Eletriptan's compliance with Eletriptan specifications and serves as a tool for batch-level quality control.
Eletriptan CoA mostly includes findings from lab analyses of a specific batch. For each Eletriptan 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.
Eletriptan may be tested according to a variety of international standards, such as European Pharmacopoeia (Eletriptan EP), Eletriptan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eletriptan USP).
