01 1Aurobindo Pharma Limited
02 1CTX Lifesciences
03 1Emcure Pharmaceuticals
04 2Formosa Laboratories
05 1Ind Swift Laboratories Limited
06 1Lupin Ltd
07 1Navinta
08 1Royal DSM
09 1Solara Active Pharma Sciences
10 1Waterstone Pharmaceuticals Inc.
01 11COLESEVELAM HYDROCHLORIDE
01 1China
02 6India
03 1Netherlands
04 2Taiwan
05 1U.S.A
01 8Active
02 3Inactive
01 6Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-01-30
Pay. Date : 2016-10-28
DMF Number : 31095
Submission : 2016-11-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-02-12
Pay. Date : 2013-12-05
DMF Number : 26934
Submission : 2013-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-01-13
Pay. Date : 2015-11-16
DMF Number : 30001
Submission : 2015-11-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-01
Pay. Date : 2013-04-18
DMF Number : 22870
Submission : 2009-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26813
Submission : 2013-02-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23333
Submission : 2010-04-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38605
Submission : 2023-07-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-08-04
Pay. Date : 2015-01-14
DMF Number : 28945
Submission : 2014-12-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-20
DMF Number : 23378
Submission : 2009-12-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37431
Submission : 2022-12-22
Status : Active
Type : II
A Colesevelam manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Colesevelam, including repackagers and relabelers. The FDA regulates Colesevelam manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Colesevelam 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 Colesevelam manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Colesevelam supplier is an individual or a company that provides Colesevelam active pharmaceutical ingredient (API) or Colesevelam finished formulations upon request. The Colesevelam suppliers may include Colesevelam API manufacturers, exporters, distributors and traders.
click here to find a list of Colesevelam suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Colesevelam DMF (Drug Master File) is a document detailing the whole manufacturing process of Colesevelam active pharmaceutical ingredient (API) in detail. Different forms of Colesevelam DMFs exist exist since differing nations have different regulations, such as Colesevelam USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Colesevelam DMF submitted to regulatory agencies in the US is known as a USDMF. Colesevelam USDMF includes data on Colesevelam's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Colesevelam USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Colesevelam suppliers with USDMF on PharmaCompass.
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