01 1Charioteer
02 1Lupin Ltd
03 1Zydus Lifesciences
01 3LETERMOVIR
01 1China
02 2India
01 3Active
01 2Complete
02 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39852
Submission : 2024-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-07-06
Pay. Date : 2021-06-16
DMF Number : 35981
Submission : 2021-06-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-09-29
Pay. Date : 2021-09-17
DMF Number : 36024
Submission : 2021-06-19
Status : Active
Type : II
A Letermovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Letermovir, including repackagers and relabelers. The FDA regulates Letermovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Letermovir 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 Letermovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Letermovir supplier is an individual or a company that provides Letermovir active pharmaceutical ingredient (API) or Letermovir finished formulations upon request. The Letermovir suppliers may include Letermovir API manufacturers, exporters, distributors and traders.
click here to find a list of Letermovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Letermovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Letermovir active pharmaceutical ingredient (API) in detail. Different forms of Letermovir DMFs exist exist since differing nations have different regulations, such as Letermovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Letermovir DMF submitted to regulatory agencies in the US is known as a USDMF. Letermovir USDMF includes data on Letermovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Letermovir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Letermovir suppliers with USDMF on PharmaCompass.
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