01 1Royal DSM
01 1DEXPANTHENOL
01 1Netherlands
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-08-01
Pay. Date : 2017-01-09
DMF Number : 30723
Submission : 2016-09-02
Status : Active
Type : II
A D-Panthenol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of D-Panthenol, including repackagers and relabelers. The FDA regulates D-Panthenol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. D-Panthenol 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 D-Panthenol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A D-Panthenol supplier is an individual or a company that provides D-Panthenol active pharmaceutical ingredient (API) or D-Panthenol finished formulations upon request. The D-Panthenol suppliers may include D-Panthenol API manufacturers, exporters, distributors and traders.
click here to find a list of D-Panthenol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A D-Panthenol DMF (Drug Master File) is a document detailing the whole manufacturing process of D-Panthenol active pharmaceutical ingredient (API) in detail. Different forms of D-Panthenol DMFs exist exist since differing nations have different regulations, such as D-Panthenol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A D-Panthenol DMF submitted to regulatory agencies in the US is known as a USDMF. D-Panthenol USDMF includes data on D-Panthenol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The D-Panthenol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of D-Panthenol suppliers with USDMF on PharmaCompass.
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