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