01 2Bayer AG
02 1Corden Pharma Bergamo S.p.A
03 1Divis Laboratories
04 1Fine Organics
05 1SALSBURY CHEMICALS INC
06 1Shanghai Ziyuan Pharmaceutical
07 1Solara Active Pharma Sciences
08 2Zhejiang Jiuzhou Pharmaceutical
09 2Blank
01 1SALAZOSULFAPYRIDINE
02 1SALAZOSULFAPYRIDINE AS PRODUCED IN THE BERGKAMEN PLANT
03 4SULFASALAZINE
04 1SULFASALAZINE PVP
05 1SULFASALAZINE STARCH POWDER
06 1SULFASALAZINE-PVP
07 3SULPHAZINE
01 3China
02 2Germany
03 2India
04 1Italy
05 1U.S.A
06 1United Kingdom
07 2Blank
01 1Active
02 11Inactive
01 12Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5145
Submission : 1983-10-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7242
Submission : 1987-11-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11163
Submission : 1994-10-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16817
Submission : 2003-09-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8886
Submission : 1990-12-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14688
Submission : 2000-01-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14751
Submission : 2000-03-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14724
Submission : 2000-02-23
Status : Inactive
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6489
Submission : 1986-07-17
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7127
Submission : 1987-08-17
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
A Sulfasalazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulfasalazine, including repackagers and relabelers. The FDA regulates Sulfasalazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulfasalazine 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 Sulfasalazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulfasalazine supplier is an individual or a company that provides Sulfasalazine active pharmaceutical ingredient (API) or Sulfasalazine finished formulations upon request. The Sulfasalazine suppliers may include Sulfasalazine API manufacturers, exporters, distributors and traders.
click here to find a list of Sulfasalazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sulfasalazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Sulfasalazine active pharmaceutical ingredient (API) in detail. Different forms of Sulfasalazine DMFs exist exist since differing nations have different regulations, such as Sulfasalazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sulfasalazine DMF submitted to regulatory agencies in the US is known as a USDMF. Sulfasalazine USDMF includes data on Sulfasalazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sulfasalazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sulfasalazine suppliers with USDMF on PharmaCompass.
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