01 1Alivus Life Sciences
02 1Johnson & Johnson Innovative Medicine
01 1TELAPREVIR
02 1TELAPREVIR DRUG SUBSTANCE (R600109)
01 1India
02 1U.S.A
01 1Active
02 1Inactive
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-28
Pay. Date : 2013-12-05
DMF Number : 27665
Submission : 2014-07-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23787
Submission : 2010-06-24
Status : Inactive
Type : II
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PharmaCompass offers a list of Telaprevir 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 Telaprevir manufacturer or Telaprevir supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Telaprevir manufacturer or Telaprevir supplier.
PharmaCompass also assists you with knowing the Telaprevir API Price utilized in the formulation of products. Telaprevir API Price is not always fixed or binding as the Telaprevir Price is obtained through a variety of data sources. The Telaprevir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Telaprevir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Telaprevir, including repackagers and relabelers. The FDA regulates Telaprevir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Telaprevir 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 Telaprevir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Telaprevir supplier is an individual or a company that provides Telaprevir active pharmaceutical ingredient (API) or Telaprevir finished formulations upon request. The Telaprevir suppliers may include Telaprevir API manufacturers, exporters, distributors and traders.
click here to find a list of Telaprevir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Telaprevir DMF (Drug Master File) is a document detailing the whole manufacturing process of Telaprevir active pharmaceutical ingredient (API) in detail. Different forms of Telaprevir DMFs exist exist since differing nations have different regulations, such as Telaprevir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Telaprevir DMF submitted to regulatory agencies in the US is known as a USDMF. Telaprevir USDMF includes data on Telaprevir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Telaprevir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Telaprevir suppliers with USDMF on PharmaCompass.
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