01 1Alembic Pharmaceuticals Limited
02 1Apotex Pharmachem
03 1Aurore Life Sciences
04 1Chemi SpA
05 1Dipharma
06 1Hetero Drugs
07 1Intas Pharmaceuticals
08 1Lek Pharmaceuticals
09 1Lupin Ltd
10 1MSN Laboratories
11 1Maithri Drugs
12 1Raks Pharma
13 1Sun Pharmaceutical Industries Limited
14 1Wockhardt
15 1Zydus Lifesciences
01 14FESOTERODINE FUMARATE
02 1FESOTERODINE FUMARATE [ROUTE CODE FF]
01 1Canada
02 11India
03 2Italy
04 1Slovenia
01 13Active
02 2Inactive
01 12Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-06
Pay. Date : 2012-11-02
DMF Number : 26241
Submission : 2012-09-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-23
Pay. Date : 2012-11-23
DMF Number : 26345
Submission : 2012-08-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2012-11-09
DMF Number : 25052
Submission : 2011-06-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-26
Pay. Date : 2012-11-29
DMF Number : 26427
Submission : 2012-09-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-14
Pay. Date : 2012-10-26
DMF Number : 26503
Submission : 2012-10-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-24
Pay. Date : 2012-10-31
DMF Number : 26275
Submission : 2012-10-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-03
Pay. Date : 2012-11-23
DMF Number : 26370
Submission : 2012-09-07
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-27
Pay. Date : 2012-10-26
DMF Number : 26392
Submission : 2012-08-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-16
Pay. Date : 2012-11-23
DMF Number : 26173
Submission : 2012-10-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-29
Pay. Date : 2012-11-09
DMF Number : 25916
Submission : 2012-05-17
Status : Active
Type : II
A Fesoterodine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fesoterodine, including repackagers and relabelers. The FDA regulates Fesoterodine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fesoterodine 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 Fesoterodine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fesoterodine supplier is an individual or a company that provides Fesoterodine active pharmaceutical ingredient (API) or Fesoterodine finished formulations upon request. The Fesoterodine suppliers may include Fesoterodine API manufacturers, exporters, distributors and traders.
click here to find a list of Fesoterodine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Fesoterodine DMF (Drug Master File) is a document detailing the whole manufacturing process of Fesoterodine active pharmaceutical ingredient (API) in detail. Different forms of Fesoterodine DMFs exist exist since differing nations have different regulations, such as Fesoterodine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Fesoterodine DMF submitted to regulatory agencies in the US is known as a USDMF. Fesoterodine USDMF includes data on Fesoterodine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Fesoterodine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Fesoterodine suppliers with USDMF on PharmaCompass.
We have 15 companies offering Fesoterodine
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