01 1Disphar International
02 1Henan Purui Pharmaceutical
03 1Sifavitor srl
01 1BETAHISTINE DIHYDROCHLORIDE
02 1BETAHISTINE HYDROCHLORIDE
03 1BETAHISTINE.2HCL, 8MG AND 16MG TABLETS
01 1China
02 1Italy
03 1Netherlands
01 2Active
02 1Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19593
Submission : 2006-06-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36103
Submission : 2021-07-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19495
Submission : 2006-06-05
Status : Active
Type : II
A Betahistine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betahistine, including repackagers and relabelers. The FDA regulates Betahistine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betahistine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Betahistine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Betahistine supplier is an individual or a company that provides Betahistine active pharmaceutical ingredient (API) or Betahistine finished formulations upon request. The Betahistine suppliers may include Betahistine API manufacturers, exporters, distributors and traders.
click here to find a list of Betahistine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Betahistine DMF (Drug Master File) is a document detailing the whole manufacturing process of Betahistine active pharmaceutical ingredient (API) in detail. Different forms of Betahistine DMFs exist exist since differing nations have different regulations, such as Betahistine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betahistine DMF submitted to regulatory agencies in the US is known as a USDMF. Betahistine USDMF includes data on Betahistine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betahistine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betahistine suppliers with USDMF on PharmaCompass.
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