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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.
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.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.
Neuland Laboratories- A dedicated 100% API provider.
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
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China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
6-(4-amino-2,6-dichlorophenoxy)- 4-isopropylpyrida...
CAS Number : 920509-28-0
End Use API : Resmetirom
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 experie...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
3,6-dichloro-4-isopropylpyridazine
CAS Number : 107228-51-3
End Use API : Resmetirom
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 experie...
China's leading API and intermediate manufacturer, offering CMO/CDMO services and exports to 70+ countries, enhancing global health.
4-(Propan-2-yl)pyridazine-3,6-diol
CAS Number : 1903632-97-2
End Use API : Resmetirom
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 experie...
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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.
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).
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