01 1SIGMA TAU
01 1ARECOLINE HYDROBROMIDE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3415
Submission : 1978-12-14
Status : Inactive
Type : II
A Arecoline Hydrobromide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Arecoline Hydrobromide, including repackagers and relabelers. The FDA regulates Arecoline Hydrobromide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Arecoline Hydrobromide 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 Arecoline Hydrobromide supplier is an individual or a company that provides Arecoline Hydrobromide active pharmaceutical ingredient (API) or Arecoline Hydrobromide finished formulations upon request. The Arecoline Hydrobromide suppliers may include Arecoline Hydrobromide API manufacturers, exporters, distributors and traders.
click here to find a list of Arecoline Hydrobromide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Arecoline Hydrobromide DMF (Drug Master File) is a document detailing the whole manufacturing process of Arecoline Hydrobromide active pharmaceutical ingredient (API) in detail. Different forms of Arecoline Hydrobromide DMFs exist exist since differing nations have different regulations, such as Arecoline Hydrobromide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Arecoline Hydrobromide DMF submitted to regulatory agencies in the US is known as a USDMF. Arecoline Hydrobromide USDMF includes data on Arecoline Hydrobromide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Arecoline Hydrobromide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Arecoline Hydrobromide suppliers with USDMF on PharmaCompass.
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