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List of Drug Master Files (KDMF) for Oteracil Potassium Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Formosa Laboratories, Inc. (1)

02 Kyungbo Pharmaceutical Co., Ltd. (1)

03 Qilu Pharmaceutical Co. Ltd. (1)

04 Sumitomo Chemicals Co., Ltd. Gifu Plant, Oita Works (1)

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01 Jeil Pharmaceutical Co., Ltd. (1)

02 Kyungbo Pharmaceutical Co., Ltd. (1)

03 Myungmoon Pharmaceutical Co., Ltd. (1)

04 Sampoong Pharmachem Co., Ltd. (1)

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01 Otheracil Potassium (4)

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01 China (1)

02 Japan (1)

03 South Korea (1)

04 Taiwan (1)

URL Supplier Web Content
Myungmoon Pharmaceutical Co., Ltd.
2016-01-20
Number 2400-1-ND
Formosa Laboratories, Inc...
Taiwan
36, Hoping Street, Louchu...
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Kyungbo Pharmaceutical Co., Ltd.
2009-11-25
459-2-ND
Kyungbo Pharmaceutical Co...
South Korea
174, Silok-ro, Asan-si, C...
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Sampoong Pharmachem Co., Ltd.
2013-04-09
Number 5643-2-ND
Qilu Pharmaceutical Co. L...
China
No. 243 Gong Ye Bei Road,...
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Jeil Pharmaceutical Co., Ltd.
2003-07-22
21-2-ND
Sumitomo Chemicals Co., L...
Japan
3750, Aza Juhachicho, Mak...
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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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Oteracil Potassium Drug Master File in Korea (Oteracil Potassium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oteracil Potassium. The MFDS reviews the Oteracil Potassium KDMF as part of the drug registration process and uses the information provided in the Oteracil Potassium KDMF to evaluate the safety and efficacy of the drug.

After submitting a Oteracil Potassium KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Oteracil Potassium API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Oteracil Potassium suppliers with KDMF 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. Qilu Antibiotics Pharmaceutical Co., Ltd.
  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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