01 1Recordati
01 1BROMODIPHENHYDRAMINE hcl bulk
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4431
Submission : 1982-01-21
Status : Inactive
Type : II
A Bromazine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bromazine Hydrochloride, including repackagers and relabelers. The FDA regulates Bromazine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bromazine Hydrochloride 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 Bromazine Hydrochloride supplier is an individual or a company that provides Bromazine Hydrochloride active pharmaceutical ingredient (API) or Bromazine Hydrochloride finished formulations upon request. The Bromazine Hydrochloride suppliers may include Bromazine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Bromazine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bromazine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Bromazine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Bromazine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Bromazine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bromazine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Bromazine Hydrochloride USDMF includes data on Bromazine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bromazine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bromazine Hydrochloride suppliers with USDMF on PharmaCompass.
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