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

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01 Shanghai SyntheAll Pharmaceutical Co., Ltd (1)

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01 AstraZeneca Korea Co., Ltd. (1)

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01 Roxadustat (1)

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01 China (1)

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AstraZeneca Korea Co., Ltd.
2021-07-09
Wed248-16-ND
Shanghai SyntheAll Pharma...
China
No.9, Yuegong Road, Jinsh...
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Looking for 808118-40-3 / Roxadustat API manufacturers, exporters & distributors?

Roxadustat manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Roxadustat

Synonyms

Fg-4592, 808118-40-3, Fg4592, Roxadustat (fg-4592), Asp1517, N-[(4-hydroxy-1-methyl-7-phenoxy-3-isoquinolinyl)carbonyl]glycine

Cas Number

808118-40-3

Unique Ingredient Identifier (UNII)

X3O30D9YMX

About Roxadustat

Roxadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), with potential anti-anemic activity. Upon administration, roxadustat binds to and inhibits HIF-PHI, an enzyme responsible for the degradation of transcription factors in the HIF family under normal oxygen conditions. This prevents HIF breakdown and promotes HIF activity. Increased HIF activity leads to an increase in endogenous erythropoietin production, thereby enhancing erythropoiesis. It also reduces the expression of the peptide hormone hepcidin, improves iron availability, and boosts hemoglobin (Hb) levels. HIF regulates the expression of genes in response to reduced oxygen levels, including genes required for erythropoiesis and iron metabolism.

Roxadustat Manufacturers

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

Roxadustat Suppliers

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

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

Roxadustat KDMF

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

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

After submitting a Roxadustat 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 Roxadustat API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Roxadustat suppliers with KDMF on PharmaCompass.

Roxadustat Manufacturers | Traders | Suppliers

Roxadustat Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Roxadustat

Get in contact with the supplier of your choice:

  1. WuXi AppTec Inc.
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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