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List of Drug Master Files (DMF) of Ertapenem Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 ACS DOBFAR SPA (1)

02 Asymchem Laboratories (1)

03 Aurobindo Pharma Limited (1)

04 GLAND PHARMA LIMITED (1)

05 Hospira, Inc. (1)

06 JILIN ASYMCHEM LABORATORIES CO LTD (1)

07 Qilu Antibiotics Pharmaceutical Co., Ltd. (1)

08 Shandong Anhong Pharmaceutical (1)

09 Solara Active Pharma Sciences (1)

10 Sun Pharmaceutical Industries Limited (1)

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01 ERTAPENEM SODIUM (9)

02 ERTAPENEM SODIUM (PROCESS I) (1)

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01 China (2)

02 India (4)

03 Italy (1)

04 U.S.A (3)

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01 Active (8)

02 Inactive (2)

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01 Complete (6)

02 Blank (4)

URL Supplier Web Content
29102
Active
2015-04-13
Complete
2015-09-30
2015-04-17
II
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URL Supplier Web Content
29473
Inactive
2015-06-12
N/A
II
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URL Supplier Web Content
30311
Active
2016-03-07
Complete
2016-04-13
2016-03-03
II
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URL Supplier Web Content
32424
Active
2018-01-12
Complete
2018-04-20
2018-01-11
II
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URL Supplier Web Content
27348
Inactive
2013-09-24
N/A
II
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URL Supplier Web Content
37463
Active
2023-03-02
N/A
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URL Supplier Web Content
30709
Active
2016-05-19
Complete
2017-03-03
2016-08-22
II
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URL Supplier Web Content
37232
Active
2022-08-29
Complete
2022-09-30
2022-08-19
II
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URL Supplier Web Content
28391
Active
2014-06-16
N/A
II
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URL Supplier Web Content
30123
Active
2016-01-07
Complete
2016-02-25
2015-12-30
II
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Looking for 153773-82-1 / ertapenem sodium API manufacturers, exporters & distributors?

ertapenem sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of ertapenem sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right ertapenem sodium manufacturer or ertapenem sodium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred ertapenem sodium manufacturer or ertapenem sodium supplier.

PharmaCompass also assists you with knowing the ertapenem sodium API Price utilized in the formulation of products. ertapenem sodium API Price is not always fixed or binding as the ertapenem sodium Price is obtained through a variety of data sources. The ertapenem sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

ertapenem sodium

Synonyms

Ertapenem monosodium, Ertapenem sodium [usan], Ertapenem monosodium (90per cent), 153773-82-1, Mk 0826, Sodium;(4r,5s,6s)-3-[(3s,5s)-5-[(3-carboxylatophenyl)carbamoyl]pyrrolidin-1-ium-3-yl]sulfanyl-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate

Cas Number

153773-82-1

About ertapenem sodium

A carbapenem derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of Gram-positive and Gram-negative bacterial infections including intra-abdominal infections, acute gynecological infections, complicated urinary tract infections, skin infections, and respiratory tract infections. It is also used to prevent infection in colorectal surgery.

Ertapenem Manufacturers

A Ertapenem manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ertapenem, including repackagers and relabelers. The FDA regulates Ertapenem manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ertapenem 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Ertapenem Suppliers

A Ertapenem supplier is an individual or a company that provides Ertapenem active pharmaceutical ingredient (API) or Ertapenem finished formulations upon request. The Ertapenem suppliers may include Ertapenem API manufacturers, exporters, distributors and traders.

click here to find a list of Ertapenem suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Ertapenem USDMF

A Ertapenem DMF (Drug Master File) is a document detailing the whole manufacturing process of Ertapenem active pharmaceutical ingredient (API) in detail. Different forms of Ertapenem DMFs exist exist since differing nations have different regulations, such as Ertapenem USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ertapenem DMF submitted to regulatory agencies in the US is known as a USDMF. Ertapenem USDMF includes data on Ertapenem's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ertapenem USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Ertapenem suppliers with USDMF on PharmaCompass.

Ertapenem Manufacturers | Traders | Suppliers

Ertapenem Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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