IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
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30 13Blank
IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-13
Pay. Date : 2014-06-09
DMF Number : 22431
Submission : 2009-01-15
Status :
Type : II
A Gofen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gofen, including repackagers and relabelers. The FDA regulates Gofen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gofen 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 Gofen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gofen supplier is an individual or a company that provides Gofen active pharmaceutical ingredient (API) or Gofen finished formulations upon request. The Gofen suppliers may include Gofen API manufacturers, exporters, distributors and traders.
click here to find a list of Gofen suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gofen DMF (Drug Master File) is a document detailing the whole manufacturing process of Gofen active pharmaceutical ingredient (API) in detail. Different forms of Gofen DMFs exist exist since differing nations have different regulations, such as Gofen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gofen DMF submitted to regulatory agencies in the US is known as a USDMF. Gofen USDMF includes data on Gofen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gofen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gofen suppliers with USDMF on PharmaCompass.
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