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

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01 Lundbeck Pharmaceuticals Italy S. p. A (1)

02 Mitsubishi Tanabe Pharma Factory Co., Ltd. (2)

03 Tianjin Weijie Pharmaceutical Co. , Ltd. (1)

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01 Argatroban hydrate (4)

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01 China (1)

02 Denmark (1)

03 Japan (2)

URL Supplier Web Content
227MF10090
Via Quarta Strada, 2 Padova, Italy
2015-03-12
2015-03-12
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228MF10013
3-2-10 Doshomachi, Chuo-ku, Osaka-s...
2016-01-08
2016-01-08
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222MF10221
3-16-89 Kashima, Yodogawa-ku, Osaka...
2017-02-08
2010-08-23
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230MF10006
28 Qixia Street Hangu Morden Indust...
2018-01-10
2018-01-10
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Looking for 74863-84-6 / Argatroban Monohydrate API manufacturers, exporters & distributors?

Argatroban Monohydrate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Argatroban Monohydrate

Synonyms

Argatroban, 141396-28-3, Argatroban hydrate, Argatroban (monohydrate), Argipidine, Gn1600

Cas Number

74863-84-6

Unique Ingredient Identifier (UNII)

IY90U61Z3S

About Argatroban Monohydrate

Argatroban is a synthetic derivative of L-arginine with antithrombotic activity. Argatroban is a univalent and direct inhibitor of fibrin-bound thrombin. This agent reversibly binds to the thrombin active site thereby preventing the thrombin-dependent reactions, which include conversion of fibrinogen to fibrin; the activation of factors V, VIII and XI; the activation of protein C; and platelet aggregation. Argatroban is highly selective for thrombin and is able to inhibit the action of both free and clot-associated thrombin. As a result, stabilization of blood clots and coagulation is inhibited.

Argatroban Monohydrate Manufacturers

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

Argatroban Monohydrate Suppliers

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

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

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

Argatroban Monohydrate Manufacturers | Traders | Suppliers

Argatroban Monohydrate Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Argatroban Monohydrate

Get in contact with the supplier of your choice:

  1. H. Lundbeck AS
  2. Mitsubishi Tanabe Pharma
  3. Tianjin Weijie Pharmaceutical 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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