01 1Corden Pharma Bergamo S.p.A
02 1DOTTIKON EXCLUSIVE SYNTHESIS AG
03 2Emcure Pharmaceuticals
04 1Pfizer Inc
05 1Viatris
01 5OLSALAZINE SODIUM
02 1OLSALAZINE SODIUM (PROCESS II)
01 2India
02 1Italy
03 1Switzerland
04 2U.S.A
01 3Active
02 3Inactive
01 6Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21981
Submission : 2008-09-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17677
Submission : 2004-09-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27618
Submission : 2013-12-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21633
Submission : 2008-05-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6443
Submission : 1986-06-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39269
Submission : 2023-12-20
Status : Active
Type : II
A Olsalazine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Olsalazine, including repackagers and relabelers. The FDA regulates Olsalazine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Olsalazine 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 Olsalazine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Olsalazine supplier is an individual or a company that provides Olsalazine active pharmaceutical ingredient (API) or Olsalazine finished formulations upon request. The Olsalazine suppliers may include Olsalazine API manufacturers, exporters, distributors and traders.
click here to find a list of Olsalazine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Olsalazine DMF (Drug Master File) is a document detailing the whole manufacturing process of Olsalazine active pharmaceutical ingredient (API) in detail. Different forms of Olsalazine DMFs exist exist since differing nations have different regulations, such as Olsalazine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Olsalazine DMF submitted to regulatory agencies in the US is known as a USDMF. Olsalazine USDMF includes data on Olsalazine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Olsalazine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Olsalazine suppliers with USDMF on PharmaCompass.
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