01 1Xian Libang Pharmaceutical Co.,Ltd
01 1AMLODIPINE MALEATE AND BESYLATE (NON-STERILE BULK DRUG SUBSTANCE)
01 1China
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17130
Submission : 2004-01-23
Status : Inactive
Type : II
A Amlodipine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amlodipine Maleate, including repackagers and relabelers. The FDA regulates Amlodipine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amlodipine Maleate 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 Amlodipine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amlodipine Maleate supplier is an individual or a company that provides Amlodipine Maleate active pharmaceutical ingredient (API) or Amlodipine Maleate finished formulations upon request. The Amlodipine Maleate suppliers may include Amlodipine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Amlodipine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amlodipine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amlodipine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Amlodipine Maleate DMFs exist exist since differing nations have different regulations, such as Amlodipine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amlodipine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Amlodipine Maleate USDMF includes data on Amlodipine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amlodipine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amlodipine Maleate suppliers with USDMF on PharmaCompass.
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