01 1Mallinckrodt Pharmaceuticals
02 1RP SCHERER GMBH & CO. KG
03 1Blank
01 1DIOCTYL SODIUM SULFOSUCCINATE 100mg & GASANTHRANOL 30mg. CAPSULES.
02 1DIOCTYL SODIUM SULFOSUCCINATE IN P E G
03 1MICRO-ENEMA
01 1Germany
02 1Ireland
03 1Blank
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3123
Submission : 1978-01-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1729
Submission : 1971-06-01
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3057
Submission : 1977-08-30
Status : Inactive
Type : II
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A Docusate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Docusate, including repackagers and relabelers. The FDA regulates Docusate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Docusate 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 Docusate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Docusate supplier is an individual or a company that provides Docusate active pharmaceutical ingredient (API) or Docusate finished formulations upon request. The Docusate suppliers may include Docusate API manufacturers, exporters, distributors and traders.
click here to find a list of Docusate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Docusate DMF (Drug Master File) is a document detailing the whole manufacturing process of Docusate active pharmaceutical ingredient (API) in detail. Different forms of Docusate DMFs exist exist since differing nations have different regulations, such as Docusate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Docusate DMF submitted to regulatory agencies in the US is known as a USDMF. Docusate USDMF includes data on Docusate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Docusate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Docusate suppliers with USDMF on PharmaCompass.
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