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USDMF
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-23
Pay. Date : 2016-04-18
DMF Number : 30475
Submission : 2016-04-21
Status :
Type : II
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ABOUT THIS PAGE
A Fycompa manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fycompa, including repackagers and relabelers. The FDA regulates Fycompa manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fycompa 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 Fycompa manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fycompa supplier is an individual or a company that provides Fycompa active pharmaceutical ingredient (API) or Fycompa finished formulations upon request. The Fycompa suppliers may include Fycompa API manufacturers, exporters, distributors and traders.
click here to find a list of Fycompa suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fycompa DMF (Drug Master File) is a document detailing the whole manufacturing process of Fycompa active pharmaceutical ingredient (API) in detail. Different forms of Fycompa DMFs exist exist since differing nations have different regulations, such as Fycompa USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fycompa DMF submitted to regulatory agencies in the US is known as a USDMF. Fycompa USDMF includes data on Fycompa's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fycompa USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fycompa suppliers with USDMF 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 Fycompa Drug Master File in Korea (Fycompa KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Fycompa. The MFDS reviews the Fycompa KDMF as part of the drug registration process and uses the information provided in the Fycompa KDMF to evaluate the safety and efficacy of the drug.
After submitting a Fycompa 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 Fycompa API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Fycompa suppliers with KDMF 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 Fycompa as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Fycompa 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 Fycompa 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 Fycompa and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fycompa NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Fycompa suppliers with NDC on PharmaCompass.
Fycompa 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 Fycompa 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 Fycompa GMP manufacturer or Fycompa GMP API supplier for your needs.
A Fycompa CoA (Certificate of Analysis) is a formal document that attests to Fycompa's compliance with Fycompa specifications and serves as a tool for batch-level quality control.
Fycompa CoA mostly includes findings from lab analyses of a specific batch. For each Fycompa 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.
Fycompa may be tested according to a variety of international standards, such as European Pharmacopoeia (Fycompa EP), Fycompa JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Fycompa USP).
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