01 1Lee Pharma
02 1Blank
01 2RESMETIROM
01 1India
02 1Blank
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39990
Submission : 2024-05-27
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40872
Submission : 2024-11-26
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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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.
