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