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