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

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01 FORMOSA LABORATORIES, INC. (1)

02 Kyongbo Pharmaceutical Co. , Ltd. (1)

03 Shiratori Pharmaceutical Co., Ltd. (1)

04 Sumitomo Chemical Co., Ltd. (1)

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01 Oteracil potassium (3)

02 Oteracil potassium production dedicated (1)

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01 Japan (2)

02 South Korea (1)

03 Taiwan (1)

URL Supplier Web Content
224MF10134
36 Hoping Street, Louchu, Taoyuan 3...
2013-05-22
2012-07-19
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224MF10034
174, Sirok-ro, Asan-si, Chungcheong...
2012-02-15
2012-02-15
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225MF10004
6-11-24 Tsudanuma, Narashino City, ...
2013-01-18
2013-01-18
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219MF10375
2-27-1 Shinkawa, Chuo-ku, Tokyo
2007-12-19
2007-12-19
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Looking for 2207-75-2 / Oteracil Potassium API manufacturers, exporters & distributors?

Oteracil Potassium manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Oteracil Potassium

Synonyms

2207-75-2, Oxonic acid potassium salt, Allantoxanic acid potassium salt, Potassium azaorotate, Oxonic acid, potassium salt, Potassium 4,6-dioxo-1,4,5,6-tetrahydro-1,3,5-triazine-2-carboxylate

Cas Number

2207-75-2

Unique Ingredient Identifier (UNII)

4R7FFA00RX

About Oteracil Potassium

Oteracil Potassium is the potassium salt of oxonate, an enzyme inhibitor that modulates 5- fluorouracil (5-FU) toxicity. Potassium oxonate inhibits orotate phosphoribosyltransferase, which catalyzes the conversion of 5-FU to its active or phosphorylated form, FUMP. Upon oral administration, Oxonate is selectively distributed to the intracellular sites of tissues lining the small intestines, producing localized inhibitory effects within the gastrointestinal tract. As a result, 5-FU associated gastrointestinal toxic effects are reduced and the incidence of diarrhea or mucositis is decreased in 5-FU related therapy.

Oteracil Potassium Manufacturers

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

Oteracil Potassium Suppliers

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

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

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

Oteracil Potassium Manufacturers | Traders | Suppliers

Oteracil Potassium Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Oteracil Potassium

Get in contact with the supplier of your choice:

  1. Formosa Laboratories
  2. Kyongbo Pharmaceutical Co., Ltd
  3. Shiratori Pharmaceutical
  4. Sumitomo Chemical
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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