01 1ACS DOBFAR SPA
02 1Asymchem Laboratories
03 1Aurobindo Pharma Limited
04 1GLAND CHEMICALS PRIVATE LIMITED
05 1GLAND PHARMA LIMITED
06 1Hospira, Inc.
07 1JILIN ASYMCHEM LABORATORIES CO LTD
08 1Qilu Antibiotics Pharmaceutical Co., Ltd.
09 1Shandong Anhong Pharmaceutical
10 1Solara Active Pharma Sciences
11 1Sun Pharmaceutical Industries Limited
01 10ERTAPENEM SODIUM
02 1ERTAPENEM SODIUM (PROCESS I)
01 3China
02 5India
03 1Italy
04 2U.S.A
01 9Active
02 2Inactive
01 6Complete
02 5Blank
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-30
Pay. Date : 2015-04-17
DMF Number : 29102
Submission : 2015-04-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-04-13
Pay. Date : 2016-03-03
DMF Number : 30311
Submission : 2016-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40191
Submission : 2024-09-13
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-20
Pay. Date : 2018-01-11
DMF Number : 32424
Submission : 2018-01-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27348
Submission : 2013-09-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37463
Submission : 2023-03-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-03
Pay. Date : 2016-08-22
DMF Number : 30709
Submission : 2016-05-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-09-30
Pay. Date : 2022-08-19
DMF Number : 37232
Submission : 2022-08-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28391
Submission : 2014-06-16
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-02-25
Pay. Date : 2015-12-30
DMF Number : 30123
Submission : 2016-01-07
Status : Active
Type : II
A Ertapenem Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ertapenem Sodium, including repackagers and relabelers. The FDA regulates Ertapenem Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ertapenem Sodium 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 Ertapenem Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ertapenem Sodium supplier is an individual or a company that provides Ertapenem Sodium active pharmaceutical ingredient (API) or Ertapenem Sodium finished formulations upon request. The Ertapenem Sodium suppliers may include Ertapenem Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Ertapenem Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ertapenem Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Ertapenem Sodium active pharmaceutical ingredient (API) in detail. Different forms of Ertapenem Sodium DMFs exist exist since differing nations have different regulations, such as Ertapenem Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ertapenem Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Ertapenem Sodium USDMF includes data on Ertapenem Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ertapenem Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ertapenem Sodium suppliers with USDMF on PharmaCompass.
We have 11 companies offering Ertapenem Sodium
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