01 2ALP Pharm
02 1Actavis Inc
03 1Aurobindo Pharma Limited
04 1MSN Laboratories
01 2China
02 2India
03 1Ireland
01 2Active
02 2Inactive
03 1Blank
01 5Blank
01 5Blank
01 1WC-0383A4
02 4Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-05
Pay. Date : 2020-09-29
DMF Number : 30563
Submission : 2016-05-31
Status : Active
Type : II
Date of Issue : 2019-10-15
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A4
Address of the Firm :
NDC Package Code : 69766-012
Start Marketing Date : 2016-05-23
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-19
Pay. Date : 2016-05-18
DMF Number : 30553
Submission : 2016-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24035
Submission : 2010-07-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25908
Submission : 2012-04-02
Status : Inactive
Type : II
A Entereg manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Entereg, including repackagers and relabelers. The FDA regulates Entereg manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Entereg 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 Entereg manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Entereg supplier is an individual or a company that provides Entereg active pharmaceutical ingredient (API) or Entereg finished formulations upon request. The Entereg suppliers may include Entereg API manufacturers, exporters, distributors and traders.
click here to find a list of Entereg suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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