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List of Korea Drug Master Files (KDMF) for Cilastatin Sodium Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Hitech Farm Co., Ltd.
2020-10-15
20201015-210-J-652
ACS Dobfar SPA@[Cilastati...
Italy
Viale Addetta, 2a/12-3/5 ...
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Sungjin Exim Co., Ltd.
2021-07-19
20201015-210-J-652(1)
ACS Dobfar SpA@[Cilastati...
Italy
Viale Addetta, 2a/12-3/5 ...
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Dongguk Life Science Co., Ltd.
2018-06-08
20180608-210-J-227
Dongkuk Life Science Co.,...
South Korea
54-1, Taejanggongdan-gil,...
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JW Pharmaceutical Co., Ltd.
2020-06-17
20200617-210-J-653
JW Pharmaceutical Co., Lt...
South Korea
56 Gyeongje-ro, Siheung-s...
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  • POWDER;INTRAVENOUS - EQ 250MG BASE/VIAL;250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • POWDER;INTRAVENOUS - EQ 500MG BASE/VIAL;500MG/VIAL

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.

Cilastatin Sodium Manufacturers

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

Cilastatin Sodium Suppliers

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

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

Cilastatin Sodium KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Cilastatin Sodium Drug Master File in Korea (Cilastatin Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Cilastatin Sodium. The MFDS reviews the Cilastatin Sodium KDMF as part of the drug registration process and uses the information provided in the Cilastatin Sodium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Cilastatin Sodium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Cilastatin Sodium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Cilastatin Sodium suppliers with KDMF on PharmaCompass.

Cilastatin Sodium Manufacturers | Traders | Suppliers

Cilastatin Sodium Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Cilastatin Sodium

Get in contact with the supplier of your choice:

  1. ACS DOBFAR SPA
  2. Dongkook Lifescience
  3. JW Pharmaceutical 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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