Synopsis
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CEP/COS
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JDMF
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KDMF
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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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Europe
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Canada
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Australia
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
US Medicaid
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Annual Reports
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Regulatory FDF Prices
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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.
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Lewens Labs transforms healthcare with innovative, sustainable, and affordable pharmaceutical solutions worldwide.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
Evonik's CDMO solutions for APIs and HPAPIs: It specializes where the client needs it most!
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, & custom-made solutions to our customers.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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USDMF
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42713
Submission : 2025-09-30
Status :
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42172
Submission : 2025-08-08
Status :
Type : II
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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. specializes in R&D and production of APIs and advanced intermediates, CDMO/CRO/OEM, and Technology Transfer of Finished Formulat...
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...
Delivering quality and niche Active Pharmaceutical Ingredients across the global from our USFDA-approved facility.
About the Company : Mankind Pharma, came into existence in 1986. In 1991, the company was formed into a legal corporation. However, it actively started working as a fully integrated pharmaceutical com...
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...
Lewens Labs transforms healthcare with innovative, sustainable, and affordable pharmaceutical solutions worldwide.
About the Company : Lewens Labs was established with a vision to transform the pharmaceutical industry, inspired by an award-winning engineering project that reduced the cost of Aceclofenac and earned...
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
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...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
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PharmaCompass offers a list of Resmetirom 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 Resmetirom manufacturer or Resmetirom supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Resmetirom manufacturer or Resmetirom supplier.
PharmaCompass also assists you with knowing the Resmetirom API Price utilized in the formulation of products. Resmetirom API Price is not always fixed or binding as the Resmetirom Price is obtained through a variety of data sources. The Resmetirom Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Resmetirom manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Resmetirom, including repackagers and relabelers. The FDA regulates Resmetirom manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Resmetirom 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 Resmetirom manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Resmetirom supplier is an individual or a company that provides Resmetirom active pharmaceutical ingredient (API) or Resmetirom finished formulations upon request. The Resmetirom suppliers may include Resmetirom API manufacturers, exporters, distributors and traders.
click here to find a list of Resmetirom suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Resmetirom DMF (Drug Master File) is a document detailing the whole manufacturing process of Resmetirom active pharmaceutical ingredient (API) in detail. Different forms of Resmetirom DMFs exist exist since differing nations have different regulations, such as Resmetirom USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Resmetirom DMF submitted to regulatory agencies in the US is known as a USDMF. Resmetirom USDMF includes data on Resmetirom's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Resmetirom USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Resmetirom suppliers with USDMF on PharmaCompass.
A Resmetirom written confirmation (Resmetirom WC) is an official document issued by a regulatory agency to a Resmetirom manufacturer, verifying that the manufacturing facility of a Resmetirom active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Resmetirom APIs or Resmetirom finished pharmaceutical products to another nation, regulatory agencies frequently require a Resmetirom WC (written confirmation) as part of the regulatory process.
click here to find a list of Resmetirom 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 Resmetirom as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Resmetirom 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 Resmetirom 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 Resmetirom and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Resmetirom NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Resmetirom suppliers with NDC on PharmaCompass.
Resmetirom 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 Resmetirom 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 Resmetirom GMP manufacturer or Resmetirom GMP API supplier for your needs.
A Resmetirom CoA (Certificate of Analysis) is a formal document that attests to Resmetirom's compliance with Resmetirom specifications and serves as a tool for batch-level quality control.
Resmetirom CoA mostly includes findings from lab analyses of a specific batch. For each Resmetirom 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.
Resmetirom may be tested according to a variety of international standards, such as European Pharmacopoeia (Resmetirom EP), Resmetirom JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Resmetirom USP).
