01 1ALP Pharm
02 1Alembic Pharmaceuticals Limited
03 1Alkem Laboratories
04 1Aurobindo Pharma Limited
05 1HEC Pharm
06 1HONOUR LAB LTD
07 2Jiangxi Synergy Pharmaceutical
08 1Jubilant Generics
09 1Lupin Ltd
10 2MSN Laboratories
11 1Piramal Pharma Solutions
12 1Reyoung pharmaceutical
13 1Takeda Pharmaceutical
14 1Zhejiang Tianyu Pharmaceutical Co., Ltd
15 1Blank
01 3AZILSARTAN
02 7AZILSARTAN KAMEDOXOMIL
03 1AZILSARTAN KAMEDOXOMIL NON-STERILE BULK DRUG SUBSTANCE
04 1AZILSARTAN KAMEDOXOMIL [ROUTE CODE "AK"]
05 1AZILSARTAN MEDOXOMIL
06 1AZILSARTAN MEDOXOMIL MONOPOTASSIUM
07 2AZILSARTAN MEDOXOMIL POTASSIUM
08 1TAK-536 DRUG SUBSTANCE
01 6China
02 8India
03 1Japan
04 1U.S.A
05 1Blank
01 16Active
02 1Inactive
01 7Complete
02 10Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-10
Pay. Date : 2015-06-26
DMF Number : 29488
Submission : 2015-06-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29818
Submission : 2015-09-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-21
Pay. Date : 2020-09-28
DMF Number : 35239
Submission : 2020-09-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-27
Pay. Date : 2014-08-26
DMF Number : 28452
Submission : 2014-08-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-01-04
Pay. Date : 2017-08-08
DMF Number : 31895
Submission : 2017-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29785
Submission : 2015-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-07-12
Pay. Date : 2019-06-05
DMF Number : 33732
Submission : 2019-04-17
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-06
Pay. Date : 2021-06-23
DMF Number : 28092
Submission : 2014-03-27
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35932
Submission : 2021-06-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-10-13
Pay. Date : 2021-08-26
DMF Number : 35770
Submission : 2021-03-31
Status : Active
Type : II
A Azilsartan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azilsartan, including repackagers and relabelers. The FDA regulates Azilsartan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azilsartan 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 Azilsartan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azilsartan supplier is an individual or a company that provides Azilsartan active pharmaceutical ingredient (API) or Azilsartan finished formulations upon request. The Azilsartan suppliers may include Azilsartan API manufacturers, exporters, distributors and traders.
click here to find a list of Azilsartan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azilsartan DMF (Drug Master File) is a document detailing the whole manufacturing process of Azilsartan active pharmaceutical ingredient (API) in detail. Different forms of Azilsartan DMFs exist exist since differing nations have different regulations, such as Azilsartan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azilsartan DMF submitted to regulatory agencies in the US is known as a USDMF. Azilsartan USDMF includes data on Azilsartan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azilsartan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azilsartan suppliers with USDMF on PharmaCompass.
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