01 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
01 1HYOSCYAMINE SULFATE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28614
Submission : 2014-09-02
Status : Active
Type : II
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A Duboisine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Duboisine, including repackagers and relabelers. The FDA regulates Duboisine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Duboisine 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 Duboisine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Duboisine supplier is an individual or a company that provides Duboisine active pharmaceutical ingredient (API) or Duboisine finished formulations upon request. The Duboisine suppliers may include Duboisine API manufacturers, exporters, distributors and traders.
click here to find a list of Duboisine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Duboisine DMF (Drug Master File) is a document detailing the whole manufacturing process of Duboisine active pharmaceutical ingredient (API) in detail. Different forms of Duboisine DMFs exist exist since differing nations have different regulations, such as Duboisine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Duboisine DMF submitted to regulatory agencies in the US is known as a USDMF. Duboisine USDMF includes data on Duboisine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Duboisine USDMF is kept confidential to protect the manufacturer’s intellectual property.
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