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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PharmaCompass offers a list of Oteracil Potassium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Oteracil Potassium manufacturer or Oteracil Potassium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oteracil Potassium manufacturer or Oteracil Potassium supplier.
A Potassium otastat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium otastat, including repackagers and relabelers. The FDA regulates Potassium otastat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium otastat 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 Potassium otastat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Potassium otastat supplier is an individual or a company that provides Potassium otastat active pharmaceutical ingredient (API) or Potassium otastat finished formulations upon request. The Potassium otastat suppliers may include Potassium otastat API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium otastat suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Potassium otastat DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium otastat active pharmaceutical ingredient (API) in detail. Different forms of Potassium otastat DMFs exist exist since differing nations have different regulations, such as Potassium otastat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium otastat DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium otastat USDMF includes data on Potassium otastat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium otastat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium otastat suppliers with USDMF on PharmaCompass.
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