01 1Cyclo Therapeutics
02 1Roquette
01 1HYDROXYPROPYL BETADEX
02 1TRAPPSOL® CYCLO™
01 1France
02 1U.S.A
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28889
Submission : 2014-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30897
Submission : 2016-08-29
Status : Active
Type : II
A Hydroxypropyl-Beta Cyclodextrin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxypropyl-Beta Cyclodextrin, including repackagers and relabelers. The FDA regulates Hydroxypropyl-Beta Cyclodextrin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxypropyl-Beta Cyclodextrin 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 Hydroxypropyl-Beta Cyclodextrin supplier is an individual or a company that provides Hydroxypropyl-Beta Cyclodextrin active pharmaceutical ingredient (API) or Hydroxypropyl-Beta Cyclodextrin finished formulations upon request. The Hydroxypropyl-Beta Cyclodextrin suppliers may include Hydroxypropyl-Beta Cyclodextrin API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxypropyl-Beta Cyclodextrin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydroxypropyl-Beta Cyclodextrin DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxypropyl-Beta Cyclodextrin active pharmaceutical ingredient (API) in detail. Different forms of Hydroxypropyl-Beta Cyclodextrin DMFs exist exist since differing nations have different regulations, such as Hydroxypropyl-Beta Cyclodextrin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxypropyl-Beta Cyclodextrin DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxypropyl-Beta Cyclodextrin USDMF includes data on Hydroxypropyl-Beta Cyclodextrin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxypropyl-Beta Cyclodextrin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxypropyl-Beta Cyclodextrin suppliers with USDMF on PharmaCompass.
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