01 1Boehringer Ingelheim GmbH
02 1Hubei Biocause Heilen Pharmaceutical Co., Ltd
01 2HYOSCYAMINE SULFATE
01 1China
02 1Germany
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9351
Submission : 1991-09-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28614
Submission : 2014-09-02
Status : Active
Type : II
A Hyoscyamine Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hyoscyamine Sulfate, including repackagers and relabelers. The FDA regulates Hyoscyamine Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hyoscyamine Sulfate 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 Hyoscyamine Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hyoscyamine Sulfate supplier is an individual or a company that provides Hyoscyamine Sulfate active pharmaceutical ingredient (API) or Hyoscyamine Sulfate finished formulations upon request. The Hyoscyamine Sulfate suppliers may include Hyoscyamine Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Hyoscyamine Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hyoscyamine Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Hyoscyamine Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Hyoscyamine Sulfate DMFs exist exist since differing nations have different regulations, such as Hyoscyamine Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hyoscyamine Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Hyoscyamine Sulfate USDMF includes data on Hyoscyamine Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hyoscyamine Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hyoscyamine Sulfate suppliers with USDMF on PharmaCompass.
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