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List of Japan Drug Master File (JDMF) for Linezolid Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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226MF10166
36 Hoping Street, Louchu, Taoyuan 3...
2014-11-17
2014-09-01
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  • TABLET;ORAL - 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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  • SOLUTION;INTRAVENOUS - 400MG/200ML (2MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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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 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 Linezolid Drug Master File in Japan (Linezolid JDMF) empowers Linezolid 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 Linezolid JDMF during the approval evaluation for pharmaceutical products. At the time of Linezolid 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 Linezolid suppliers with JDMF on PharmaCompass.

Linezolid Manufacturers | Traders | Suppliers

Linezolid Manufacturers, Traders, Suppliers 1
32

We have 3 companies offering Linezolid

Get in contact with the supplier of your choice:

  1. Formosa Laboratories
  2. Glenmark Life Sciences
  3. Jubilant Generics
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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