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
93
PharmaCompass offers a list of Potassium Bitartrate 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 Potassium Bitartrate manufacturer or Potassium Bitartrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Potassium Bitartrate manufacturer or Potassium Bitartrate supplier.
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, and COA 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, and COA 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.
We have 1 companies offering Potassium Bitartrate
Get in contact with the supplier of your choice:
