01 1F.I.S. Fabbrica Italiana Sintetici
02 2GLAND PHARMA LIMITED
03 1Solara Active Pharma Sciences
01 2INDOMETHACIN SODIUM
02 2INDOMETHACIN SODIUM USP
01 3India
02 1Italy
01 4Active
01 2Complete
02 2Blank
GDUFA
DMF Review : Complete
Rev. Date : 2016-05-31
Pay. Date : 2015-09-30
DMF Number : 29441
Submission : 2015-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25401
Submission : 2011-10-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-22
Pay. Date : 2014-11-28
DMF Number : 27282
Submission : 2013-10-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22751
Submission : 2009-04-29
Status : Active
Type : II
A Indomethacin Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indomethacin Sodium, including repackagers and relabelers. The FDA regulates Indomethacin Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indomethacin Sodium 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 Indomethacin Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indomethacin Sodium supplier is an individual or a company that provides Indomethacin Sodium active pharmaceutical ingredient (API) or Indomethacin Sodium finished formulations upon request. The Indomethacin Sodium suppliers may include Indomethacin Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Indomethacin Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indomethacin Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Indomethacin Sodium active pharmaceutical ingredient (API) in detail. Different forms of Indomethacin Sodium DMFs exist exist since differing nations have different regulations, such as Indomethacin Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indomethacin Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Indomethacin Sodium USDMF includes data on Indomethacin Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indomethacin Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indomethacin Sodium suppliers with USDMF on PharmaCompass.
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