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List of Drug Master Files (JDMF) for IMIPENEM; CILASTATIN Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 ACS DOBFAR S. p. A. (1)

02 JW Pharmaceutical Corporation (1)

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01 Cilastatin Sodium (1)

02 Cilastatin sodium (1)

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01 Italy (1)

02 Blank (1)

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304MF10136
Viale Addetta, 4/12, 20067 Tribiano...
2022-10-05
2022-10-05
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219MF10001
2477, Nambusunhwan-ro Seocho-gu, Se...
2012-05-11
2007-01-18
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Looking for 81129-83-1 / Cilastatin Sodium API manufacturers, exporters & distributors?

Cilastatin Sodium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Cilastatin Sodium

Synonyms

81129-83-1, Cilastatin sodium salt, Cilastatin na, Mls001401364, Sodium;(z)-7-[(2r)-2-amino-2-carboxyethyl]sulfanyl-2-[[(1s)-2,2-dimethylcyclopropanecarbonyl]amino]hept-2-enoate, Mk-791

Cas Number

81129-83-1

About Cilastatin Sodium

A renal dehydropeptidase-I and leukotriene D4 dipeptidase inhibitor. Since the antibiotic, IMIPENEM, is hydrolyzed by dehydropeptidase-I, which resides in the brush border of the renal tubule, cilastatin is administered with imipenem to increase its effectiveness. The drug also inhibits the metabolism of leukotriene D4 to leukotriene E4.

IMIPENEM; CILASTATIN Manufacturers

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

IMIPENEM; CILASTATIN Suppliers

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

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

IMIPENEM; CILASTATIN JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The IMIPENEM; CILASTATIN Drug Master File in Japan (IMIPENEM; CILASTATIN JDMF) empowers IMIPENEM; CILASTATIN API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the IMIPENEM; CILASTATIN JDMF during the approval evaluation for pharmaceutical products. At the time of IMIPENEM; CILASTATIN JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of IMIPENEM; CILASTATIN suppliers with JDMF on PharmaCompass.

IMIPENEM; CILASTATIN Manufacturers | Traders | Suppliers

IMIPENEM; CILASTATIN Manufacturers, Traders, Suppliers 1
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We have 2 companies offering IMIPENEM; CILASTATIN

Get in contact with the supplier of your choice:

  1. ACS DOBFAR SPA
  2. Choongwae Pharma Corporation
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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