Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Chunghwa Chemical Synthesis & Biotech
03 1AK & MN BioFarm
04 2AK AND MN BIOFARM CO LTD
05 1BASF
06 2Bizen Chemical Co. - Ltd
07 1Catalent Pharma Solutions
08 2Chemport Inc
09 1Huatai Biopharm
10 2K.D. Pharma Bexbach GmbH
11 2KinOmega Biopharm Inc.
12 2NIPPON SUISAN KAISHA LTD
13 1NISSHIN PHARMA INC
14 2Shandong Xinhua Pharmaceutical
15 1Sichuan Gowell Pharmaceutical
16 1Skuny Bioscience Co.,Ltd
17 2Zhejiang Medicine Co Ltd
01 1AK & MN BIOFARM ICOSAPENTATE
02 1AMR101 1G CAPSULES
03 1BIZEN EPA-E (ICOSAPENT ETHYL) DRUG SUBSTANCE
04 1EICOSAPENTAENOIC ACID ETHYL ESTER
05 1EICOSAPENTAENOIC ACID ETHYL ESTER (EPA-E)
06 1EICOSAPENTAENOIC ACID, 90% ETHYL ESTER
07 1EPA 550/DHA 200 FFA
08 1EPA ETHYL ESTER
09 1EPA ETHYL ESTER 70
10 1EPA-E DRUG SUBSTANCE
11 1EPA-E NISSUI KASHIMA
12 1EPA-E NISSUI TSUKUBA
13 1EPA960EE (ICOSAPENT ETHYL)
14 2ETHYL ICOSAPENTATE
15 2ETHYL ICOSAPENTATE 70
16 1ETHYL ICOSAPENTATE 98
17 6ICOSAPENT ETHYL
18 1ICOSAPENTOSAN EQ
01 9China
02 4Germany
03 5Japan
04 3South Korea
05 1Taiwan
06 1U.S.A
07 2United Kingdom
01 22Active
02 3Inactive
01 10Complete
02 15Blank
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-07
Pay. Date : 2023-06-05
DMF Number : 27182
Submission : 2013-05-23
Status : Active
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-01
Pay. Date : 2012-11-20
DMF Number : 26271
Submission : 2012-08-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26946
Submission : 2013-03-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27998
Submission : 2014-02-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-02
Pay. Date : 2020-10-20
DMF Number : 23911
Submission : 2010-07-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30007
Submission : 2015-11-04
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-21
Pay. Date : 2013-02-27
DMF Number : 26892
Submission : 2013-02-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-20
Pay. Date : 2014-04-09
DMF Number : 28140
Submission : 2014-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22474
Submission : 2009-01-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15062
Submission : 2000-09-29
Status : Active
Type : II
A Eicosapentaenoic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eicosapentaenoic Acid, including repackagers and relabelers. The FDA regulates Eicosapentaenoic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eicosapentaenoic Acid 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 Eicosapentaenoic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eicosapentaenoic Acid supplier is an individual or a company that provides Eicosapentaenoic Acid active pharmaceutical ingredient (API) or Eicosapentaenoic Acid finished formulations upon request. The Eicosapentaenoic Acid suppliers may include Eicosapentaenoic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Eicosapentaenoic Acid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eicosapentaenoic Acid DMF (Drug Master File) is a document detailing the whole manufacturing process of Eicosapentaenoic Acid active pharmaceutical ingredient (API) in detail. Different forms of Eicosapentaenoic Acid DMFs exist exist since differing nations have different regulations, such as Eicosapentaenoic Acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eicosapentaenoic Acid DMF submitted to regulatory agencies in the US is known as a USDMF. Eicosapentaenoic Acid USDMF includes data on Eicosapentaenoic Acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eicosapentaenoic Acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eicosapentaenoic Acid suppliers with USDMF on PharmaCompass.
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