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