01 1ATPGroup
01 1POTASSIUM BITARTRATE, USP/FCC
01 1U.S.A
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-05
Pay. Date : 2022-12-30
DMF Number : 29204
Submission : 2015-02-27
Status : Active
Type : II
A Potassium Bitartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium Bitartrate, including repackagers and relabelers. The FDA regulates Potassium Bitartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Potassium Bitartrate 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 Bitartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Potassium Bitartrate supplier is an individual or a company that provides Potassium Bitartrate active pharmaceutical ingredient (API) or Potassium Bitartrate finished formulations upon request. The Potassium Bitartrate suppliers may include Potassium Bitartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium Bitartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium Bitartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium Bitartrate active pharmaceutical ingredient (API) in detail. Different forms of Potassium Bitartrate DMFs exist exist since differing nations have different regulations, such as Potassium Bitartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium Bitartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium Bitartrate USDMF includes data on Potassium Bitartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium Bitartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium Bitartrate suppliers with USDMF on PharmaCompass.
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