01 1Bayer AG
02 1Cerestar USA Inc
03 1Pharmatech
04 1Roquette
05 2Wacker Chemie AG
01 12-HYDROXYPROPYL-B-CYCLODEXTRIN
02 1BETA CYCLODEXTRIN
03 2BETA-CYCLODEXTRIN
04 1METHYL BETA-CYCLODEXTRIN
05 1NOCLOPROST BETA-CYCLODEXTRIN CLATHRATE
01 1France
02 3Germany
03 1U.S.A
04 1United Kingdom
01 3Active
02 3Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8423
Submission : 1990-02-02
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9403
Submission : 1991-10-21
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7435
Submission : 1988-04-14
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9155
Submission : 1991-06-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15489
Submission : 2001-06-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14620
Submission : 1999-12-08
Status : Active
Type : IV
A Beta-Cyclodextrin API manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Beta-Cyclodextrin API, including repackagers and relabelers. The FDA regulates Beta-Cyclodextrin API manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Beta-Cyclodextrin API 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 Beta-Cyclodextrin API supplier is an individual or a company that provides Beta-Cyclodextrin API active pharmaceutical ingredient (API) or Beta-Cyclodextrin API finished formulations upon request. The Beta-Cyclodextrin API suppliers may include Beta-Cyclodextrin API API manufacturers, exporters, distributors and traders.
click here to find a list of Beta-Cyclodextrin API suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Beta-Cyclodextrin API DMF (Drug Master File) is a document detailing the whole manufacturing process of Beta-Cyclodextrin API active pharmaceutical ingredient (API) in detail. Different forms of Beta-Cyclodextrin API DMFs exist exist since differing nations have different regulations, such as Beta-Cyclodextrin API USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Beta-Cyclodextrin API DMF submitted to regulatory agencies in the US is known as a USDMF. Beta-Cyclodextrin API USDMF includes data on Beta-Cyclodextrin API's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Beta-Cyclodextrin API USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Beta-Cyclodextrin API suppliers with USDMF on PharmaCompass.
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