01 13M Company
02 1Aurore Life Sciences
03 1Kreative Organics
04 1Raks Pharma
05 1Wanbury Limited
01 2SALSALATE
02 3SALSALATE USP
01 4India
02 1U.S.A
01 4Active
02 1Inactive
01 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8848
Submission : 1990-08-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34515
Submission : 2020-01-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26031
Submission : 2012-04-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23637
Submission : 2010-03-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31123
Submission : 2016-10-28
Status : Active
Type : II
A Salsalate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Salsalate, including repackagers and relabelers. The FDA regulates Salsalate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Salsalate 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 Salsalate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Salsalate supplier is an individual or a company that provides Salsalate active pharmaceutical ingredient (API) or Salsalate finished formulations upon request. The Salsalate suppliers may include Salsalate API manufacturers, exporters, distributors and traders.
click here to find a list of Salsalate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Salsalate DMF (Drug Master File) is a document detailing the whole manufacturing process of Salsalate active pharmaceutical ingredient (API) in detail. Different forms of Salsalate DMFs exist exist since differing nations have different regulations, such as Salsalate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Salsalate DMF submitted to regulatory agencies in the US is known as a USDMF. Salsalate USDMF includes data on Salsalate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Salsalate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Salsalate suppliers with USDMF on PharmaCompass.
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