HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
01 1HRV Global Life Sciences
02 1Aurobindo Pharma Limited
03 1CTX Lifesciences
04 1DEAFARMA
05 1Emcure Pharmaceuticals
06 2Formosa Laboratories
07 1Glenmark Pharmaceuticals
08 1Hetero Drugs
09 1Ind Swift Laboratories Limited
10 1Lupin Ltd
11 1Navinta
12 1Royal DSM
13 1Solara Active Pharma Sciences
14 1Vijayasri Organics Limited
15 1Waterstone Pharmaceuticals Inc.
01 1China
02 10India
03 1Italy
04 1Netherlands
05 2Taiwan
06 1U.S.A
01 8Active
02 3Inactive
03 5Blank
01 16Blank
01 16Blank
01 1WC-0127
02 1WC-0226
03 14Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38605
Submission : 2023-07-18
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-07
Pay. Date : 2013-02-20
DMF Number : 23378
Submission : 2009-12-16
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-01
Pay. Date : 2013-04-18
DMF Number : 22870
Submission : 2009-06-16
Status : Active
Type : II
NDC Package Code : 66499-0022
Start Marketing Date : 2008-07-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-01-13
Pay. Date : 2015-11-16
DMF Number : 30001
Submission : 2015-11-13
Status : Active
Type : II
NDC Package Code : 66499-0022
Start Marketing Date : 2008-07-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-12
Pay. Date : 2013-12-05
DMF Number : 26934
Submission : 2013-03-31
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
NDC Package Code : 14593-829
Start Marketing Date : 2020-03-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-08-04
Pay. Date : 2015-01-14
DMF Number : 28945
Submission : 2014-12-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37431
Submission : 2022-12-22
Status : Active
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 : 26813
Submission : 2013-02-05
Status : Inactive
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.
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