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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
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USDMF
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15244
Submission : 2001-01-15
Status :
Type : II
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API Imports and Exports
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Drugs in Development
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DOSAGE - TABLET;ORAL - 100MG **Federal Regist...DOSAGE - TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18830
DOSAGE - TABLET;ORAL - 150MG **Federal Regist...DOSAGE - TABLET;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18830
DOSAGE - TABLET;ORAL - 50MG **Federal Registe...DOSAGE - TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18830
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Flecainide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Flecainide, including repackagers and relabelers. The FDA regulates Flecainide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Flecainide 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 Flecainide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Flecainide supplier is an individual or a company that provides Flecainide active pharmaceutical ingredient (API) or Flecainide finished formulations upon request. The Flecainide suppliers may include Flecainide API manufacturers, exporters, distributors and traders.
click here to find a list of Flecainide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Flecainide DMF (Drug Master File) is a document detailing the whole manufacturing process of Flecainide active pharmaceutical ingredient (API) in detail. Different forms of Flecainide DMFs exist exist since differing nations have different regulations, such as Flecainide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Flecainide DMF submitted to regulatory agencies in the US is known as a USDMF. Flecainide USDMF includes data on Flecainide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Flecainide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Flecainide 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 Flecainide Drug Master File in Japan (Flecainide JDMF) empowers Flecainide 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 Flecainide JDMF during the approval evaluation for pharmaceutical products. At the time of Flecainide 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 Flecainide 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 Flecainide Drug Master File in Korea (Flecainide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Flecainide. The MFDS reviews the Flecainide KDMF as part of the drug registration process and uses the information provided in the Flecainide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Flecainide 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 Flecainide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Flecainide suppliers with KDMF on PharmaCompass.
A Flecainide CEP of the European Pharmacopoeia monograph is often referred to as a Flecainide Certificate of Suitability (COS). The purpose of a Flecainide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Flecainide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Flecainide to their clients by showing that a Flecainide CEP has been issued for it. The manufacturer submits a Flecainide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Flecainide CEP holder for the record. Additionally, the data presented in the Flecainide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Flecainide DMF.
A Flecainide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Flecainide 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 Flecainide suppliers with CEP (COS) on PharmaCompass.
A Flecainide written confirmation (Flecainide WC) is an official document issued by a regulatory agency to a Flecainide manufacturer, verifying that the manufacturing facility of a Flecainide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Flecainide APIs or Flecainide finished pharmaceutical products to another nation, regulatory agencies frequently require a Flecainide WC (written confirmation) as part of the regulatory process.
click here to find a list of Flecainide 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 Flecainide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Flecainide 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 Flecainide 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 Flecainide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Flecainide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Flecainide suppliers with NDC on PharmaCompass.
Flecainide 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 Flecainide 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 Flecainide GMP manufacturer or Flecainide GMP API supplier for your needs.
A Flecainide CoA (Certificate of Analysis) is a formal document that attests to Flecainide's compliance with Flecainide specifications and serves as a tool for batch-level quality control.
Flecainide CoA mostly includes findings from lab analyses of a specific batch. For each Flecainide 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.
Flecainide may be tested according to a variety of international standards, such as European Pharmacopoeia (Flecainide EP), Flecainide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Flecainide USP).
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