01 1Jost Chemical
02 1Macco Organiques, Spol. s.r o
01 2POTASSIUM SULFATE
01 1Czech Republic
02 1U.S.A
01 2Active
01 1Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2014-07-02
DMF Number : 23165
Submission : 2009-10-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38938
Submission : 2023-10-10
Status : Active
Type : II
A Potassium Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Sulfate, including repackagers and relabelers. The FDA regulates Potassium Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Sulfate 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 Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Sulfate supplier is an individual or a company that provides Potassium Sulfate active pharmaceutical ingredient (API) or Potassium Sulfate finished formulations upon request. The Potassium Sulfate suppliers may include Potassium Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Potassium Sulfate DMFs exist exist since differing nations have different regulations, such as Potassium Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Sulfate USDMF includes data on Potassium Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium Sulfate suppliers with USDMF on PharmaCompass.
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