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

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01 ACS DOBFAR SPA (3)

02 Aurobindo Pharma Limited (1)

03 Auronext Pharma Private Limited (1)

04 Daewoong Pharmaceutical (2)

05 Hospira, Inc. (3)

06 Kyongbo Pharmaceutical Co., Ltd (1)

07 RANBAXY LABORATORIES LIMITED (2)

08 SUZHOU HOMESUN PHARMACEUTICAL CO LTD (1)

09 Sandoz B2B (1)

10 Savior Lifetec Corporation (1)

11 Shenzhen Haibin Pharmaceutical Co., Ltd. (3)

12 Sterile India Pvt. Ltd (1)

13 Sumitomo Pharma (3)

14 Unimark Remedies Limited (2)

15 Zhejiang Hisun Pharmaceutical (1)

16 Zhejiang Jiuzhou Pharmaceutical (1)

17 Zhuhai United Laboratories Co ., Ltd. (2)

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01 CRUDE MEROPENEM (1)

02 MEROPENEM (1)

03 MEROPENEM (NON-STERILE DRUG SUBSTANCE INTERMEDIATE) (2)

04 MEROPENEM (NON-STERILE) (1)

05 MEROPENEM (STERILE) (1)

06 MEROPENEM BULK BLEND (1)

07 MEROPENEM CRUDE NON-STERILE (1)

08 MEROPENEM FOR INJECTION (1)

09 MEROPENEM FOR INJECTION (STERILE BULK) (1)

10 MEROPENEM FOR INJECTION BULK STERILE (1)

11 MEROPENEM FOR INJECTION STERILE BULK (1)

12 MEROPENEM FOR INJECTION USP (1)

13 MEROPENEM STERILE (2)

14 MEROPENEM STERILE, BULK (1)

15 MEROPENEM TECHNICAL (2)

16 MEROPENEM TRIHYDRATE NON STERILE (1)

17 MEROPENEM TRIHYDRATE STERILE (1)

18 MEROPENEM TRIHYDRATE, STERILE (1)

19 MEROPENEM USP (STERILE) (1)

20 MEROPENEM, STERILE (1)

21 MEROPENEM/SODIUM CARBONATE (1)

22 MPEP (MEROPENEM INTERMEDIATE) (1)

23 Meropenem Technical (1)

24 Meropenem USP (1)

25 STERILE MEROPENEM (1)

26 STERILE MEROPENEM FOR INFECTION (1)

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01 China (8)

02 India (7)

03 Italy (3)

04 Japan (3)

05 South Korea (3)

06 Switzerland (1)

07 Taiwan (1)

08 U.S.A (3)

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01 Active (13)

02 Inactive (16)

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01 Complete (4)

02 Blank (25)

URL Supplier Web Content
30488
Active
2016-07-21
N/A
II
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22503
Active
2009-02-04
Complete
2017-08-01
2017-07-06
II
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27168
Active
2013-06-11
Complete
2013-08-15
2013-06-10
II
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27192
Active
2013-06-18
Complete
2013-08-25
2013-06-17
II
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21061
Active
2007-11-23
N/A
II
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23524
Active
2010-02-11
N/A
II
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29985
Active
2016-11-28
N/A
II
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23276
Active
2009-11-24
N/A
II
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25869
Active
2012-03-31
N/A
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28279
Active
2014-06-07
Complete
2014-10-20
2014-07-20
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Looking for 119478-56-7 / Meropenem API manufacturers, exporters & distributors?

Meropenem manufacturers, exporters & distributors 1

17

PharmaCompass offers a list of Meropenem 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 Meropenem manufacturer or Meropenem supplier for your needs.

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

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

API | Excipient name

Meropenem

Synonyms

96036-03-2, Merrem, Meropenem anhydrous, Meropenemum, Antibiotic sm 7338, Meronem

Cas Number

119478-56-7

Unique Ingredient Identifier (UNII)

YOP6PX0BAO

About Meropenem

A thienamycin 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 bacterial infections, including infections in immunocompromised patients.

Meropenem Manufacturers

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

Meropenem Suppliers

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

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

Meropenem USDMF

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

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

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

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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