01 1BASF
02 1SI Group
03 1SMS Pharmaceuticals
04 1Shandong Xinhua Pharmaceutical
05 1Solara Active Pharma Sciences
01 1IBUPROFEN SODIUM
02 3IBUPROFEN SODIUM DIHYDRATE
03 1SODIUM IBUPROFEN DIHYDRATE
01 1China
02 1Germany
03 2India
04 1U.S.A
01 5Active
01 1Complete
02 4Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-11-26
Pay. Date : 2013-11-20
DMF Number : 21587
Submission : 2008-04-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28403
Submission : 2014-06-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23755
Submission : 2010-04-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39473
Submission : 2024-02-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23925
Submission : 2010-06-08
Status : Active
Type : II
A Ibuprofen Sodium Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibuprofen Sodium Dihydrate, including repackagers and relabelers. The FDA regulates Ibuprofen Sodium Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibuprofen Sodium Dihydrate 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 Sodium Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibuprofen Sodium Dihydrate supplier is an individual or a company that provides Ibuprofen Sodium Dihydrate active pharmaceutical ingredient (API) or Ibuprofen Sodium Dihydrate finished formulations upon request. The Ibuprofen Sodium Dihydrate suppliers may include Ibuprofen Sodium Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Ibuprofen Sodium Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ibuprofen Sodium Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ibuprofen Sodium Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Ibuprofen Sodium Dihydrate DMFs exist exist since differing nations have different regulations, such as Ibuprofen Sodium Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ibuprofen Sodium Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Ibuprofen Sodium Dihydrate USDMF includes data on Ibuprofen Sodium Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ibuprofen Sodium Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ibuprofen Sodium Dihydrate suppliers with USDMF on PharmaCompass.
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