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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PharmaCompass offers a list of Levoamlodipine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Levoamlodipine manufacturer or Levoamlodipine supplier for your needs.
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A (S)-Amlodipine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (S)-Amlodipine, including repackagers and relabelers. The FDA regulates (S)-Amlodipine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (S)-Amlodipine 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 (S)-Amlodipine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A (S)-Amlodipine supplier is an individual or a company that provides (S)-Amlodipine active pharmaceutical ingredient (API) or (S)-Amlodipine finished formulations upon request. The (S)-Amlodipine suppliers may include (S)-Amlodipine API manufacturers, exporters, distributors and traders.
click here to find a list of (S)-Amlodipine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A (S)-Amlodipine DMF (Drug Master File) is a document detailing the whole manufacturing process of (S)-Amlodipine active pharmaceutical ingredient (API) in detail. Different forms of (S)-Amlodipine DMFs exist exist since differing nations have different regulations, such as (S)-Amlodipine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (S)-Amlodipine DMF submitted to regulatory agencies in the US is known as a USDMF. (S)-Amlodipine USDMF includes data on (S)-Amlodipine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (S)-Amlodipine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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