01 1Shenyang Hongqi Pharmaceutical
02 1Viatris
01 2PRETOMANID
01 1China
02 1U.S.A
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-08
Pay. Date : 2023-12-26
DMF Number : 38642
Submission : 2023-09-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38796
Submission : 2023-10-31
Status : Active
Type : II
A Pretomanid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pretomanid, including repackagers and relabelers. The FDA regulates Pretomanid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pretomanid 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 Pretomanid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pretomanid supplier is an individual or a company that provides Pretomanid active pharmaceutical ingredient (API) or Pretomanid finished formulations upon request. The Pretomanid suppliers may include Pretomanid API manufacturers, exporters, distributors and traders.
click here to find a list of Pretomanid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pretomanid DMF (Drug Master File) is a document detailing the whole manufacturing process of Pretomanid active pharmaceutical ingredient (API) in detail. Different forms of Pretomanid DMFs exist exist since differing nations have different regulations, such as Pretomanid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pretomanid DMF submitted to regulatory agencies in the US is known as a USDMF. Pretomanid USDMF includes data on Pretomanid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pretomanid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pretomanid suppliers with USDMF on PharmaCompass.
We have 2 companies offering Pretomanid
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?