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API SUPPLIERS
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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 : 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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Lifecare Labs has been developing innovative products in specialist areas of medicine.
About the Company : Lifecare Labs specializes in producing bulk drugs (APIs) and intermediates that adhere to the industry's stringent quality parameters. Its objective is to deliver excellence throug...
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
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, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...
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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ABOUT THIS PAGE
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PharmaCompass offers a list of Perampanel 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 Perampanel manufacturer or Perampanel supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Perampanel manufacturer or Perampanel supplier.
PharmaCompass also assists you with knowing the Perampanel API Price utilized in the formulation of products. Perampanel API Price is not always fixed or binding as the Perampanel Price is obtained through a variety of data sources. The Perampanel Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Perampanel manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Perampanel, including repackagers and relabelers. The FDA regulates Perampanel manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Perampanel 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 Perampanel manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Perampanel supplier is an individual or a company that provides Perampanel active pharmaceutical ingredient (API) or Perampanel finished formulations upon request. The Perampanel suppliers may include Perampanel API manufacturers, exporters, distributors and traders.
click here to find a list of Perampanel suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Perampanel DMF (Drug Master File) is a document detailing the whole manufacturing process of Perampanel active pharmaceutical ingredient (API) in detail. Different forms of Perampanel DMFs exist exist since differing nations have different regulations, such as Perampanel USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Perampanel DMF submitted to regulatory agencies in the US is known as a USDMF. Perampanel USDMF includes data on Perampanel's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Perampanel USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Perampanel 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 Perampanel Drug Master File in Korea (Perampanel KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Perampanel. The MFDS reviews the Perampanel KDMF as part of the drug registration process and uses the information provided in the Perampanel KDMF to evaluate the safety and efficacy of the drug.
After submitting a Perampanel 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 Perampanel API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Perampanel suppliers with KDMF on PharmaCompass.
A Perampanel written confirmation (Perampanel WC) is an official document issued by a regulatory agency to a Perampanel manufacturer, verifying that the manufacturing facility of a Perampanel active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Perampanel APIs or Perampanel finished pharmaceutical products to another nation, regulatory agencies frequently require a Perampanel WC (written confirmation) as part of the regulatory process.
click here to find a list of Perampanel 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 Perampanel as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Perampanel 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 Perampanel 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 Perampanel and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Perampanel NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Perampanel suppliers with NDC on PharmaCompass.
Perampanel 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 Perampanel 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 Perampanel GMP manufacturer or Perampanel GMP API supplier for your needs.
A Perampanel CoA (Certificate of Analysis) is a formal document that attests to Perampanel's compliance with Perampanel specifications and serves as a tool for batch-level quality control.
Perampanel CoA mostly includes findings from lab analyses of a specific batch. For each Perampanel 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.
Perampanel may be tested according to a variety of international standards, such as European Pharmacopoeia (Perampanel EP), Perampanel JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Perampanel USP).
