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01 1S D Fine Chem Limited
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01 1DICHLOROMETHANE BP
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01 1India
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01 1Active
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01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28711
Submission : 2014-10-03
Status : Active
Type : IV
A Methylene Chloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylene Chloride, including repackagers and relabelers. The FDA regulates Methylene Chloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylene Chloride 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 Methylene Chloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Methylene Chloride supplier is an individual or a company that provides Methylene Chloride active pharmaceutical ingredient (API) or Methylene Chloride finished formulations upon request. The Methylene Chloride suppliers may include Methylene Chloride API manufacturers, exporters, distributors and traders.
click here to find a list of Methylene Chloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methylene Chloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Methylene Chloride active pharmaceutical ingredient (API) in detail. Different forms of Methylene Chloride DMFs exist exist since differing nations have different regulations, such as Methylene Chloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methylene Chloride DMF submitted to regulatory agencies in the US is known as a USDMF. Methylene Chloride USDMF includes data on Methylene Chloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methylene Chloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methylene Chloride suppliers with USDMF on PharmaCompass.
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