01 1Macleods Pharmaceuticals Limited
02 1Wuxi Fortune Pharmaceutical Co., Ltd
01 2RIFAPENTINE
01 1China
02 1India
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-19
Pay. Date : 2021-07-08
DMF Number : 35961
Submission : 2021-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39690
Submission : 2024-03-28
Status : Active
Type : II
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PharmaCompass offers a list of Rifapentine 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 Rifapentine manufacturer or Rifapentine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rifapentine manufacturer or Rifapentine supplier.
PharmaCompass also assists you with knowing the Rifapentine API Price utilized in the formulation of products. Rifapentine API Price is not always fixed or binding as the Rifapentine Price is obtained through a variety of data sources. The Rifapentine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rifapentine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifapentine, including repackagers and relabelers. The FDA regulates Rifapentine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifapentine 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 Rifapentine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifapentine supplier is an individual or a company that provides Rifapentine active pharmaceutical ingredient (API) or Rifapentine finished formulations upon request. The Rifapentine suppliers may include Rifapentine API manufacturers, exporters, distributors and traders.
click here to find a list of Rifapentine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifapentine DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifapentine active pharmaceutical ingredient (API) in detail. Different forms of Rifapentine DMFs exist exist since differing nations have different regulations, such as Rifapentine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifapentine DMF submitted to regulatory agencies in the US is known as a USDMF. Rifapentine USDMF includes data on Rifapentine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifapentine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifapentine suppliers with USDMF on PharmaCompass.
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