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 Sulfuric Polyester manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pentosan Sulfuric Polyester, including repackagers and relabelers. The FDA regulates Pentosan Sulfuric Polyester manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pentosan Sulfuric Polyester 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 Sulfuric Polyester manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pentosan Sulfuric Polyester supplier is an individual or a company that provides Pentosan Sulfuric Polyester active pharmaceutical ingredient (API) or Pentosan Sulfuric Polyester finished formulations upon request. The Pentosan Sulfuric Polyester suppliers may include Pentosan Sulfuric Polyester API manufacturers, exporters, distributors and traders.
click here to find a list of Pentosan Sulfuric Polyester suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pentosan Sulfuric Polyester DMF (Drug Master File) is a document detailing the whole manufacturing process of Pentosan Sulfuric Polyester active pharmaceutical ingredient (API) in detail. Different forms of Pentosan Sulfuric Polyester DMFs exist exist since differing nations have different regulations, such as Pentosan Sulfuric Polyester USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pentosan Sulfuric Polyester DMF submitted to regulatory agencies in the US is known as a USDMF. Pentosan Sulfuric Polyester USDMF includes data on Pentosan Sulfuric Polyester's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pentosan Sulfuric Polyester USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pentosan Sulfuric Polyester suppliers with USDMF on PharmaCompass.
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