01 1Sinopharm Weiqida Pharmaceutical Co Ltd
01 1CLAVULANATE POTASSIUM DILUTED 1:1 WITH MICROCRYSTALLINE CELLULOSE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-17
Pay. Date : 2014-03-21
DMF Number : 27976
Submission : 2014-03-18
Status : Active
Type : II
A Potassium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Potassium, including repackagers and relabelers. The FDA regulates Potassium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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.
A Potassium supplier is an individual or a company that provides Potassium active pharmaceutical ingredient (API) or Potassium finished formulations upon request. The Potassium suppliers may include Potassium API manufacturers, exporters, distributors and traders.
click here to find a list of Potassium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Potassium DMF (Drug Master File) is a document detailing the whole manufacturing process of Potassium active pharmaceutical ingredient (API) in detail. Different forms of Potassium DMFs exist exist since differing nations have different regulations, such as Potassium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Potassium DMF submitted to regulatory agencies in the US is known as a USDMF. Potassium USDMF includes data on Potassium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Potassium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Potassium suppliers with USDMF on PharmaCompass.
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