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

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SERVICES
Flag South Korea
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Kyungbo Pharmaceutical Co., Ltd.
2018-07-03
20180703-209-J-76
Kyungbo Pharmaceutical Co...
South Korea
174, Silok-ro, Asan-si, C...
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Toru Co., Ltd.
2022-07-08
20210623-209-J-1035(1)
Lee Pharma Limited
India
Survey No. 10/G-1, Gaddap...
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Youngjin Pharmaceutical Co., Ltd.
2022-10-31
20210623-209-J-1035(2)
Lee Pharma Limited
India
Survey No. 10/G-1, Gaddap...
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Grace Farm
2021-06-23
20210623-209-J-1035
Lee Pharma Limited
India
Survey No. 10/G-1, Gaddap...
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Pfizer Pharmaceuticals Korea Co., Ltd.
2020-07-07
20200707-209-J-414
Pfizer Asia Manufacturing...
Singapore
31 Tuas South Avenue 6 Si...
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Leesung International Co., Ltd.
2021-03-10
20210310-209-J-868
Symed Labs Limited (Unit ...
India
Plot-25/B, Phase III, IDA...
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Ace Biopharm Co., Ltd.
2022-09-02
20220902-209-J-1354
Zhejiang Changhai Pharmac...
China
188 Mid Zhiyuan Avenue, B...
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  • TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 600MG
  • SOLUTION;INTRAVENOUS - 200MG/100ML (2MG/ML)
  • SOLUTION;INTRAVENOUS - 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SOLUTION;INTRAVENOUS - 600MG/300ML (2MG/ML)

Looking for 165800-03-3 / Linezolid API manufacturers, exporters & distributors?

Linezolid manufacturers, exporters & distributors 1

55

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

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

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

API | Excipient name

Linezolid

Synonyms

165800-03-3, Zyvox, (s)-n-((3-(3-fluoro-4-morpholinophenyl)-2-oxooxazolidin-5-yl)methyl)acetamide, Pnu-100766, Zyvoxid, U-100766

Cas Number

165800-03-3

Unique Ingredient Identifier (UNII)

ISQ9I6J12J

About Linezolid

An oxazolidinone and acetamide derived ANTI-BACTERIAL AGENT and PROTEIN SYNTHESIS INHIBITOR that is used in the treatment of GRAM-POSITIVE BACTERIAL INFECTIONS of the skin and respiratory tract.

Linezolid Manufacturers

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

Linezolid Suppliers

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

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

Linezolid KDMF

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

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

After submitting a Linezolid 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 Linezolid API can apply through the Korea Drug Master File (KDMF).

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

Linezolid Manufacturers | Traders | Suppliers

Linezolid Manufacturers, Traders, Suppliers 1
13

We have 5 companies offering Linezolid

Get in contact with the supplier of your choice:

  1. Kyongbo Pharmaceutical Co., Ltd
  2. Lee Pharma
  3. Pfizer Inc
  4. Symed Labs
  5. Zhejiang Medicine Co Ltd
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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