01 1Dipharma
02 1Solara Active Pharma Sciences
01 1IBUPROFEN LYSINE
02 1IBUPROFEN LYSINE SALT
01 1India
02 1Italy
01 2Active
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21444
Submission : 2008-03-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36991
Submission : 2022-03-29
Status : Active
Type : II
A Ibuprofen Lysine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibuprofen Lysine, including repackagers and relabelers. The FDA regulates Ibuprofen Lysine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibuprofen Lysine 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 Lysine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibuprofen Lysine supplier is an individual or a company that provides Ibuprofen Lysine active pharmaceutical ingredient (API) or Ibuprofen Lysine finished formulations upon request. The Ibuprofen Lysine suppliers may include Ibuprofen Lysine API manufacturers, exporters, distributors and traders.
click here to find a list of Ibuprofen Lysine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ibuprofen Lysine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ibuprofen Lysine active pharmaceutical ingredient (API) in detail. Different forms of Ibuprofen Lysine DMFs exist exist since differing nations have different regulations, such as Ibuprofen Lysine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ibuprofen Lysine DMF submitted to regulatory agencies in the US is known as a USDMF. Ibuprofen Lysine USDMF includes data on Ibuprofen Lysine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ibuprofen Lysine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ibuprofen Lysine suppliers with USDMF on PharmaCompass.
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