01 1Lunan Pharmaceutical
02 1Sumitomo Chemical
03 1Blank
01 1OTERACIL POTASSIUM
02 1OXONIC ACID POTASSIUM SALT
03 1POTASSIUM OTASTAT
01 1China
02 1Japan
03 1Blank
01 1Active
02 2Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35057
Submission : 2021-01-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13908
Submission : 1998-12-22
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12568
Submission : 1997-06-30
Status : Inactive
Type : II
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A Oteracil Potassium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oteracil Potassium, including repackagers and relabelers. The FDA regulates Oteracil Potassium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oteracil Potassium 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 Oteracil Potassium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oteracil Potassium supplier is an individual or a company that provides Oteracil Potassium active pharmaceutical ingredient (API) or Oteracil Potassium finished formulations upon request. The Oteracil Potassium suppliers may include Oteracil Potassium API manufacturers, exporters, distributors and traders.
click here to find a list of Oteracil Potassium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oteracil Potassium DMF (Drug Master File) is a document detailing the whole manufacturing process of Oteracil Potassium active pharmaceutical ingredient (API) in detail. Different forms of Oteracil Potassium DMFs exist exist since differing nations have different regulations, such as Oteracil Potassium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oteracil Potassium DMF submitted to regulatory agencies in the US is known as a USDMF. Oteracil Potassium USDMF includes data on Oteracil Potassium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oteracil Potassium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oteracil Potassium suppliers with USDMF on PharmaCompass.
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