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
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PharmaCompass offers a list of Alpha-Cyclodextrin API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Alpha-Cyclodextrin manufacturer or Alpha-Cyclodextrin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alpha-Cyclodextrin manufacturer or Alpha-Cyclodextrin supplier.
PharmaCompass also assists you with knowing the Alpha-Cyclodextrin API Price utilized in the formulation of products. Alpha-Cyclodextrin API Price is not always fixed or binding as the Alpha-Cyclodextrin Price is obtained through a variety of data sources. The Alpha-Cyclodextrin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ACX manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ACX, including repackagers and relabelers. The FDA regulates ACX manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ACX 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 ACX supplier is an individual or a company that provides ACX active pharmaceutical ingredient (API) or ACX finished formulations upon request. The ACX suppliers may include ACX API manufacturers, exporters, distributors and traders.
click here to find a list of ACX suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ACX DMF (Drug Master File) is a document detailing the whole manufacturing process of ACX active pharmaceutical ingredient (API) in detail. Different forms of ACX DMFs exist exist since differing nations have different regulations, such as ACX USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ACX DMF submitted to regulatory agencies in the US is known as a USDMF. ACX USDMF includes data on ACX's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ACX USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ACX suppliers with USDMF on PharmaCompass.
