01 1Smruthi Organics
01 1S (-) AMLODIPINE BESILATE USP
01 1India
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24174
Submission : 2010-08-07
Status : Inactive
Type : II
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A Levamlodipine Besylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levamlodipine Besylate, including repackagers and relabelers. The FDA regulates Levamlodipine Besylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levamlodipine Besylate 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 Levamlodipine Besylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Levamlodipine Besylate supplier is an individual or a company that provides Levamlodipine Besylate active pharmaceutical ingredient (API) or Levamlodipine Besylate finished formulations upon request. The Levamlodipine Besylate suppliers may include Levamlodipine Besylate API manufacturers, exporters, distributors and traders.
click here to find a list of Levamlodipine Besylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Levamlodipine Besylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Levamlodipine Besylate active pharmaceutical ingredient (API) in detail. Different forms of Levamlodipine Besylate DMFs exist exist since differing nations have different regulations, such as Levamlodipine Besylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Levamlodipine Besylate DMF submitted to regulatory agencies in the US is known as a USDMF. Levamlodipine Besylate USDMF includes data on Levamlodipine Besylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levamlodipine Besylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Levamlodipine Besylate suppliers with USDMF on PharmaCompass.
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