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01 1Gangwal Healthcare
01 1BETADEX USP
01 1India
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39536
Submission : 2024-02-14
Status : Active
Type : IV
A Betadex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betadex, including repackagers and relabelers. The FDA regulates Betadex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 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 Betadex supplier is an individual or a company that provides Betadex active pharmaceutical ingredient (API) or Betadex finished formulations upon request. The Betadex suppliers may include Betadex API manufacturers, exporters, distributors and traders.
click here to find a list of Betadex suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betadex DMF (Drug Master File) is a document detailing the whole manufacturing process of Betadex active pharmaceutical ingredient (API) in detail. Different forms of Betadex DMFs exist exist since differing nations have different regulations, such as Betadex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betadex DMF submitted to regulatory agencies in the US is known as a USDMF. Betadex USDMF includes data on Betadex's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betadex USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betadex suppliers with USDMF on PharmaCompass.
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