Synopsis
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CEP/COS
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JDMF
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EU WC
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VMF
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EDQM
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USP
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JP
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Others
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South Africa
DRUG PRODUCT COMPOSITIONS
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FDF
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Weekly News Recap #Phispers
API SUPPLIERS
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
AMI Lifesciences is Driven by Chemistry. Powered by People.
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
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.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
AMI Lifesciences is Driven by Chemistry. Powered by People.
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USDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38889
Submission : 2023-09-28
Status :
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41232
Submission : 2025-02-25
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
About the Company : Shandong Chenghui Shuangda Pharmaceutical Co., Ltd. is specialized in R&D and production of APIs and advanced intermediates. With 22 years of production experience,the company has ...
AMI Lifesciences is Driven by Chemistry. Powered by People.
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
About the Company : MINAKEM is a cGMP custom manufacturer of small molecule API, HPAPI and steroids. All development and manufacturing activities are supported by highly skilled R&D teams, supported b...
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...
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...
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
Drugs in Development
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DATA COMPILATION #PharmaFlow
STOCK RECAP #PipelineProspector
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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ABOUT THIS PAGE
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PharmaCompass offers a list of Finerenone 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 Finerenone manufacturer or Finerenone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Finerenone manufacturer or Finerenone supplier.
PharmaCompass also assists you with knowing the Finerenone API Price utilized in the formulation of products. Finerenone API Price is not always fixed or binding as the Finerenone Price is obtained through a variety of data sources. The Finerenone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Finerenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Finerenone, including repackagers and relabelers. The FDA regulates Finerenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Finerenone 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 Finerenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Finerenone supplier is an individual or a company that provides Finerenone active pharmaceutical ingredient (API) or Finerenone finished formulations upon request. The Finerenone suppliers may include Finerenone API manufacturers, exporters, distributors and traders.
click here to find a list of Finerenone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Finerenone DMF (Drug Master File) is a document detailing the whole manufacturing process of Finerenone active pharmaceutical ingredient (API) in detail. Different forms of Finerenone DMFs exist exist since differing nations have different regulations, such as Finerenone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Finerenone DMF submitted to regulatory agencies in the US is known as a USDMF. Finerenone USDMF includes data on Finerenone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Finerenone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Finerenone 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 Finerenone Drug Master File in Korea (Finerenone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Finerenone. The MFDS reviews the Finerenone KDMF as part of the drug registration process and uses the information provided in the Finerenone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Finerenone 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 Finerenone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Finerenone 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 Finerenone as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Finerenone 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 Finerenone 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 Finerenone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Finerenone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Finerenone suppliers with NDC on PharmaCompass.
Finerenone 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 Finerenone 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 Finerenone GMP manufacturer or Finerenone GMP API supplier for your needs.
A Finerenone CoA (Certificate of Analysis) is a formal document that attests to Finerenone's compliance with Finerenone specifications and serves as a tool for batch-level quality control.
Finerenone CoA mostly includes findings from lab analyses of a specific batch. For each Finerenone 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.
Finerenone may be tested according to a variety of international standards, such as European Pharmacopoeia (Finerenone EP), Finerenone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Finerenone USP).
Comment (5)
