01 1Cipla
02 1MATRIX LABORATORIES XIAMEN LTD.
01 1AMLODIPINE MESYLATE
02 1AMLODIPINE MESYLATE MONOHYDRATE
01 1China
02 1India
01 2Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17107
Submission : 2004-01-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16552
Submission : 2003-04-28
Status : Inactive
Type : II
A Amlodipine Mesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amlodipine Mesylate, including repackagers and relabelers. The FDA regulates Amlodipine Mesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amlodipine Mesylate 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 Mesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amlodipine Mesylate supplier is an individual or a company that provides Amlodipine Mesylate active pharmaceutical ingredient (API) or Amlodipine Mesylate finished formulations upon request. The Amlodipine Mesylate suppliers may include Amlodipine Mesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Amlodipine Mesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amlodipine Mesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amlodipine Mesylate active pharmaceutical ingredient (API) in detail. Different forms of Amlodipine Mesylate DMFs exist exist since differing nations have different regulations, such as Amlodipine Mesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amlodipine Mesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Amlodipine Mesylate USDMF includes data on Amlodipine Mesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amlodipine Mesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amlodipine Mesylate suppliers with USDMF on PharmaCompass.
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