01 1Akums Lifesciences
02 1Alembic Pharmaceuticals Limited
03 1Aragen Life Sciences
04 2BENE PHARMACHEM GMBH AND CO KG
05 1CF Pharma
06 1Micro Labs Limited
07 1Pioneer Pharma
08 1Swati Spentose
09 1Viatris
01 1ELMIRON (PENTOSAN POLYSULFATE SODIUM)CAPSULES 100MG, NJ
02 1PENTOSAN POLYFULFATE SODIUM
03 6PENTOSAN POLYSULFATE SODIUM
04 1PENTOSAN POLYSULFATE SODIUM (PPS), NON-STERILE BULK DRUG SUBSTANCE
05 1PENTOSAN POLYSULFATE SP54
01 2Germany
02 1Hungary
03 5India
04 1Iraq
05 1U.S.A
01 7Active
02 3Inactive
01 2Complete
02 8Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25011
Submission : 2011-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22582
Submission : 2009-02-20
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-12
Pay. Date : 2019-08-28
DMF Number : 34095
Submission : 2019-09-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21248
Submission : 2008-01-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4439
Submission : 1981-04-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31045
Submission : 2016-10-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-14
Pay. Date : 2023-05-24
DMF Number : 38294
Submission : 2023-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8811
Submission : 1990-09-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25827
Submission : 2012-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31208
Submission : 2017-01-16
Status : Active
Type : II
A Pentosan Polysulphate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentosan Polysulphate Sodium, including repackagers and relabelers. The FDA regulates Pentosan Polysulphate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentosan Polysulphate 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 Pentosan Polysulphate Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentosan Polysulphate Sodium supplier is an individual or a company that provides Pentosan Polysulphate Sodium active pharmaceutical ingredient (API) or Pentosan Polysulphate Sodium finished formulations upon request. The Pentosan Polysulphate Sodium suppliers may include Pentosan Polysulphate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Pentosan Polysulphate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentosan Polysulphate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentosan Polysulphate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Pentosan Polysulphate Sodium DMFs exist exist since differing nations have different regulations, such as Pentosan Polysulphate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentosan Polysulphate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Pentosan Polysulphate Sodium USDMF includes data on Pentosan Polysulphate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentosan Polysulphate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentosan Polysulphate Sodium suppliers with USDMF on PharmaCompass.
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