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01 1ISOPRINOSINE (INOSIPLEX) BULK FORM
02 1ISOPRINOSINE SYRUP 5%
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01 2Inactive
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6075
Submission : 1985-07-02
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5372
Submission : 1984-04-30
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Methisoprinol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methisoprinol, including repackagers and relabelers. The FDA regulates Methisoprinol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methisoprinol 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 Methisoprinol supplier is an individual or a company that provides Methisoprinol active pharmaceutical ingredient (API) or Methisoprinol finished formulations upon request. The Methisoprinol suppliers may include Methisoprinol API manufacturers, exporters, distributors and traders.
click here to find a list of Methisoprinol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Methisoprinol DMF (Drug Master File) is a document detailing the whole manufacturing process of Methisoprinol active pharmaceutical ingredient (API) in detail. Different forms of Methisoprinol DMFs exist exist since differing nations have different regulations, such as Methisoprinol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Methisoprinol DMF submitted to regulatory agencies in the US is known as a USDMF. Methisoprinol USDMF includes data on Methisoprinol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Methisoprinol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Methisoprinol suppliers with USDMF on PharmaCompass.
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