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

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01 LABORATORI ALCHEMIA SRL (1)

02 Osaka Synthetic Organic Chemistry Institute Co., Ltd. (1)

03 Procos S. p. A. (1)

04 Shiono Finesse Co., Ltd. (1)

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01 Japanese Pharmacopoeia Sivelestat sodium hydrate production-only (1)

02 Sivelestat sodium hydrate (2)

03 Sivelestat sodium hydrate "SFL" (1)

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01 Italy (2)

02 Japan (2)

URL Supplier Web Content
225MF10154
Via San Faustino, 68 20134 MILANO-I...
2013-08-09
2013-08-09
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226MF10229
1-1-2 Nishinomiyahama, Nishinomiya ...
2014-12-08
2014-12-08
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225MF10161
Via Matteotti 249,28062 CAMERI (NOV...
2013-08-14
2013-08-14
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218MF10428
3-1-6 Doshomachi, Chuo-ku, Osaka-sh...
2014-05-29
2006-04-27
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Looking for 201677-61-4 / Sivelestat Sodium Hydrate API manufacturers, exporters & distributors?

Sivelestat Sodium Hydrate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sivelestat Sodium Hydrate

Synonyms

Sivelestat sodium tetrahydrate, 201677-61-4, Elaspol, Ono-5046.na, Ly544349 sodium hydrate, Sivelestat (sodium tetrahydrate)

Cas Number

201677-61-4

Unique Ingredient Identifier (UNII)

737RR8Y409

Sivelestat Sodium Hydrate Manufacturers

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

Sivelestat Sodium Hydrate Suppliers

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

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

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

Sivelestat Sodium Hydrate Manufacturers | Traders | Suppliers

Sivelestat Sodium Hydrate Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Sivelestat Sodium Hydrate

Get in contact with the supplier of your choice:

  1. Laboratori Alchemia Srl
  2. Osaka Synthetic Chemical Laboratories
  3. Procos
  4. Shiono Finesse
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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