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