01 1Bayer AG
01 1ETHINYLESTRADIOL-BETA-CYCLODEXTRIN-CLATHRATE
01 1Germany
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14960
Submission : 2000-07-25
Status : Active
Type : II
25
PharmaCompass offers a list of Alpha-Cyclodextrin 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 Alpha-Cyclodextrin manufacturer or Alpha-Cyclodextrin supplier for your needs.
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A Alfadex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alfadex, including repackagers and relabelers. The FDA regulates Alfadex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alfadex 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 Alfadex supplier is an individual or a company that provides Alfadex active pharmaceutical ingredient (API) or Alfadex finished formulations upon request. The Alfadex suppliers may include Alfadex API manufacturers, exporters, distributors and traders.
click here to find a list of Alfadex suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Alfadex DMF (Drug Master File) is a document detailing the whole manufacturing process of Alfadex active pharmaceutical ingredient (API) in detail. Different forms of Alfadex DMFs exist exist since differing nations have different regulations, such as Alfadex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Alfadex DMF submitted to regulatory agencies in the US is known as a USDMF. Alfadex USDMF includes data on Alfadex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Alfadex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Alfadex suppliers with USDMF on PharmaCompass.
