01 1Dongying Tiandong Pharmaceutical Co., Ltd.
02 1Emcure Pharmaceuticals
03 1HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO., LTD.
04 1Hangzhou Jiuyuan Gene Engineering
05 1Helios Life Sciences
06 1Hubei Enoray Biopharmaceutical
07 1Nanjing King-friend Biochemical Pharmaceutical
08 1Opocrin SpA
09 1Shandong Chenzhong Biopharmaceutical Co.
10 2Shenzhen Techdow Pharmaceutical
11 1Smithfield BioScience
12 2Yantai Dongcheng Biochemicals Co.,Ltd.
01 5ENOXAPARIN SODIUM
02 1ENOXAPARIN SODIUM (NON-STERILE BULK FORM)
03 8ENOXAPARIN SODIUM USP
01 10China
02 2India
03 1Italy
04 1U.S.A
01 12Active
02 2Inactive
01 8Complete
02 6Blank
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-16
Pay. Date : 2013-02-19
DMF Number : 18452
Submission : 2005-05-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-25
Pay. Date : 2013-12-13
DMF Number : 26947
Submission : 2013-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25242
Submission : 2011-08-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-18
Pay. Date : 2015-04-30
DMF Number : 26258
Submission : 2012-07-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-16
Pay. Date : 2018-02-20
DMF Number : 32021
Submission : 2017-12-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28665
Submission : 2014-09-23
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-24
Pay. Date : 2018-07-05
DMF Number : 32744
Submission : 2018-07-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-28
Pay. Date : 2013-03-13
DMF Number : 26891
Submission : 2013-04-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21798
Submission : 2008-07-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-15
Pay. Date : 2018-06-22
DMF Number : 31344
Submission : 2017-01-10
Status : Active
Type : II
A Lovenox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lovenox, including repackagers and relabelers. The FDA regulates Lovenox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lovenox 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 Lovenox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lovenox supplier is an individual or a company that provides Lovenox active pharmaceutical ingredient (API) or Lovenox finished formulations upon request. The Lovenox suppliers may include Lovenox API manufacturers, exporters, distributors and traders.
click here to find a list of Lovenox suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lovenox DMF (Drug Master File) is a document detailing the whole manufacturing process of Lovenox active pharmaceutical ingredient (API) in detail. Different forms of Lovenox DMFs exist exist since differing nations have different regulations, such as Lovenox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lovenox DMF submitted to regulatory agencies in the US is known as a USDMF. Lovenox USDMF includes data on Lovenox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lovenox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lovenox suppliers with USDMF on PharmaCompass.
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