01 1BASF
01 1KOLLIPHOR® HS 15
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9501
Submission : 1992-01-10
Status : Active
Type : IV
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A 2-hydroxyethyl 12-hydroxyoctadecanoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 2-hydroxyethyl 12-hydroxyoctadecanoate, including repackagers and relabelers. The FDA regulates 2-hydroxyethyl 12-hydroxyoctadecanoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 2-hydroxyethyl 12-hydroxyoctadecanoate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A 2-hydroxyethyl 12-hydroxyoctadecanoate supplier is an individual or a company that provides 2-hydroxyethyl 12-hydroxyoctadecanoate active pharmaceutical ingredient (API) or 2-hydroxyethyl 12-hydroxyoctadecanoate finished formulations upon request. The 2-hydroxyethyl 12-hydroxyoctadecanoate suppliers may include 2-hydroxyethyl 12-hydroxyoctadecanoate API manufacturers, exporters, distributors and traders.
click here to find a list of 2-hydroxyethyl 12-hydroxyoctadecanoate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 2-hydroxyethyl 12-hydroxyoctadecanoate DMF (Drug Master File) is a document detailing the whole manufacturing process of 2-hydroxyethyl 12-hydroxyoctadecanoate active pharmaceutical ingredient (API) in detail. Different forms of 2-hydroxyethyl 12-hydroxyoctadecanoate DMFs exist exist since differing nations have different regulations, such as 2-hydroxyethyl 12-hydroxyoctadecanoate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 2-hydroxyethyl 12-hydroxyoctadecanoate DMF submitted to regulatory agencies in the US is known as a USDMF. 2-hydroxyethyl 12-hydroxyoctadecanoate USDMF includes data on 2-hydroxyethyl 12-hydroxyoctadecanoate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 2-hydroxyethyl 12-hydroxyoctadecanoate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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