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