Synopsis
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CEP/COS
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VMF
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS0
FDF
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Inke S.A: APIs manufacturing plant.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
EU-WC
NDC
CA
Inke S.A: APIs manufacturing plant.
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22912
Submission : 2009-06-29
Status :
Type : II
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Inke S.A: APIs manufacturing plant.
About the Company : Inke S.A., is focused since 1980 in the development and manufacture of the highest quality Active Pharmaceutical Ingredients (APIs) with complex synthesis processes for diverse the...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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
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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
65
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 HBr manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eletriptan HBr, including repackagers and relabelers. The FDA regulates Eletriptan HBr manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eletriptan HBr 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 HBr manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eletriptan HBr supplier is an individual or a company that provides Eletriptan HBr active pharmaceutical ingredient (API) or Eletriptan HBr finished formulations upon request. The Eletriptan HBr suppliers may include Eletriptan HBr API manufacturers, exporters, distributors and traders.
click here to find a list of Eletriptan HBr suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eletriptan HBr DMF (Drug Master File) is a document detailing the whole manufacturing process of Eletriptan HBr active pharmaceutical ingredient (API) in detail. Different forms of Eletriptan HBr DMFs exist exist since differing nations have different regulations, such as Eletriptan HBr USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eletriptan HBr DMF submitted to regulatory agencies in the US is known as a USDMF. Eletriptan HBr USDMF includes data on Eletriptan HBr's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eletriptan HBr USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eletriptan HBr 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 HBr Drug Master File in Japan (Eletriptan HBr JDMF) empowers Eletriptan HBr 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 HBr JDMF during the approval evaluation for pharmaceutical products. At the time of Eletriptan HBr 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 HBr 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 HBr Drug Master File in Korea (Eletriptan HBr KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eletriptan HBr. The MFDS reviews the Eletriptan HBr KDMF as part of the drug registration process and uses the information provided in the Eletriptan HBr KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eletriptan HBr 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 HBr API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eletriptan HBr suppliers with KDMF on PharmaCompass.
A Eletriptan HBr written confirmation (Eletriptan HBr WC) is an official document issued by a regulatory agency to a Eletriptan HBr manufacturer, verifying that the manufacturing facility of a Eletriptan HBr active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eletriptan HBr APIs or Eletriptan HBr finished pharmaceutical products to another nation, regulatory agencies frequently require a Eletriptan HBr WC (written confirmation) as part of the regulatory process.
click here to find a list of Eletriptan HBr 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 HBr as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eletriptan HBr 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 HBr 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 HBr and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eletriptan HBr NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eletriptan HBr suppliers with NDC on PharmaCompass.
Eletriptan HBr 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 HBr 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 HBr GMP manufacturer or Eletriptan HBr GMP API supplier for your needs.
A Eletriptan HBr CoA (Certificate of Analysis) is a formal document that attests to Eletriptan HBr's compliance with Eletriptan HBr specifications and serves as a tool for batch-level quality control.
Eletriptan HBr CoA mostly includes findings from lab analyses of a specific batch. For each Eletriptan HBr 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 HBr may be tested according to a variety of international standards, such as European Pharmacopoeia (Eletriptan HBr EP), Eletriptan HBr JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eletriptan HBr USP).
