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01 1Aurobindo Pharma Limited
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01 1TEZACAFTOR PREMIX
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01 1India
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-10
Pay. Date : 2021-09-09
DMF Number : 36280
Submission : 2021-09-14
Status : Active
Type : II
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PharmaCompass offers a list of Tezacaftor 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 Tezacaftor manufacturer or Tezacaftor supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tezacaftor manufacturer or Tezacaftor supplier.
PharmaCompass also assists you with knowing the Tezacaftor API Price utilized in the formulation of products. Tezacaftor API Price is not always fixed or binding as the Tezacaftor Price is obtained through a variety of data sources. The Tezacaftor Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tezacaftor manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tezacaftor, including repackagers and relabelers. The FDA regulates Tezacaftor manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tezacaftor 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 Tezacaftor manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tezacaftor supplier is an individual or a company that provides Tezacaftor active pharmaceutical ingredient (API) or Tezacaftor finished formulations upon request. The Tezacaftor suppliers may include Tezacaftor API manufacturers, exporters, distributors and traders.
click here to find a list of Tezacaftor suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tezacaftor DMF (Drug Master File) is a document detailing the whole manufacturing process of Tezacaftor active pharmaceutical ingredient (API) in detail. Different forms of Tezacaftor DMFs exist exist since differing nations have different regulations, such as Tezacaftor USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tezacaftor DMF submitted to regulatory agencies in the US is known as a USDMF. Tezacaftor USDMF includes data on Tezacaftor's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tezacaftor USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tezacaftor suppliers with USDMF on PharmaCompass.
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