Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
01 1Porton Pharma Solutions
02 1Changzhou Pharmaceutical Factory
03 1MSN Laboratories
01 3BALOXAVIR MARBOXIL
01 2China
02 1India
01 3Active
01 1Complete
02 2Blank
Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40455
Submission : 2024-09-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-06
Pay. Date : 2022-02-25
DMF Number : 36657
Submission : 2021-12-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36762
Submission : 2022-03-21
Status : Active
Type : II
A Baloxavir Marboxil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Baloxavir Marboxil, including repackagers and relabelers. The FDA regulates Baloxavir Marboxil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Baloxavir Marboxil 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 Baloxavir Marboxil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Baloxavir Marboxil supplier is an individual or a company that provides Baloxavir Marboxil active pharmaceutical ingredient (API) or Baloxavir Marboxil finished formulations upon request. The Baloxavir Marboxil suppliers may include Baloxavir Marboxil API manufacturers, exporters, distributors and traders.
click here to find a list of Baloxavir Marboxil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Baloxavir Marboxil DMF (Drug Master File) is a document detailing the whole manufacturing process of Baloxavir Marboxil active pharmaceutical ingredient (API) in detail. Different forms of Baloxavir Marboxil DMFs exist exist since differing nations have different regulations, such as Baloxavir Marboxil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Baloxavir Marboxil DMF submitted to regulatory agencies in the US is known as a USDMF. Baloxavir Marboxil USDMF includes data on Baloxavir Marboxil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Baloxavir Marboxil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Baloxavir Marboxil suppliers with USDMF on PharmaCompass.
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