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

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01 Active Pharma Co., Ltd. (1)

02 Glenmark Life Sciences Limited (1)

03 PLIVA CROATIA LTD. (1)

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01 Eszopiclone (2)

02 Eszopiclone "Teva / PLIVA" (1)

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01 Croatia (1)

02 India (1)

03 Japan (1)

URL Supplier Web Content
301MF10099
2-36-1 Kanda Jimbocho, Chiyoda-ku, ...
2019-11-27
2019-11-27
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302MF10028
4th Floor, OIA House, 470, Cardinal...
2020-02-13
2020-02-13
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228MF10074
Prilaz baruna Filipovica 25,10000 Z...
2022-12-07
2016-03-24
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Looking for 138729-47-2 / Eszopiclone API manufacturers, exporters & distributors?

Eszopiclone manufacturers, exporters & distributors 1

31

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

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

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

API | Excipient name

Eszopiclone

Synonyms

138729-47-2, Lunesta, (s)-zopiclone, Estorra, Esopiclone, (+)-zopiclone

Cas Number

138729-47-2

Unique Ingredient Identifier (UNII)

UZX80K71OE

About Eszopiclone

A pyridine, pyrazine, and piperazine derivative that is used as a HYPNOTIC AND SEDATIVE in the treatment of INSOMNIA.

Eszopiclone Manufacturers

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

Eszopiclone Suppliers

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

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

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

Eszopiclone Manufacturers | Traders | Suppliers

Eszopiclone Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Eszopiclone

Get in contact with the supplier of your choice:

  1. Active Pharma
  2. Glenmark Life Sciences
  3. Pliva Hrvatska
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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