01 1Zhuhai Rundu Pharmaceutical
01 1CANDESARTAN CILEXETIL NON-STERILE BULK DRUG SUBSTANCE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37468
Submission : 2022-11-04
Status : Active
Type : II
A Candesartan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Candesartan, including repackagers and relabelers. The FDA regulates Candesartan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Candesartan 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 Candesartan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Candesartan supplier is an individual or a company that provides Candesartan active pharmaceutical ingredient (API) or Candesartan finished formulations upon request. The Candesartan suppliers may include Candesartan API manufacturers, exporters, distributors and traders.
click here to find a list of Candesartan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Candesartan DMF (Drug Master File) is a document detailing the whole manufacturing process of Candesartan active pharmaceutical ingredient (API) in detail. Different forms of Candesartan DMFs exist exist since differing nations have different regulations, such as Candesartan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Candesartan DMF submitted to regulatory agencies in the US is known as a USDMF. Candesartan USDMF includes data on Candesartan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Candesartan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Candesartan suppliers with USDMF on PharmaCompass.
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