01 1Anmol Chemicals
01 1METHYL PARABEN BP/EP/USP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39565
Submission : 2024-02-24
Status : Active
Type : IV
12
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A E218 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of E218, including repackagers and relabelers. The FDA regulates E218 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. E218 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A E218 supplier is an individual or a company that provides E218 active pharmaceutical ingredient (API) or E218 finished formulations upon request. The E218 suppliers may include E218 API manufacturers, exporters, distributors and traders.
click here to find a list of E218 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A E218 DMF (Drug Master File) is a document detailing the whole manufacturing process of E218 active pharmaceutical ingredient (API) in detail. Different forms of E218 DMFs exist exist since differing nations have different regulations, such as E218 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A E218 DMF submitted to regulatory agencies in the US is known as a USDMF. E218 USDMF includes data on E218's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The E218 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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