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

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01 Changzhou SynTheAll Pharmaceutical Co., Ltd (1)

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01 Mitsubishi Nabe Pharma Korea Co., Ltd. (1)

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01 badadustat (1)

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01 Japan (1)

URL Supplier Web Content
Mitsubishi Nabe Pharma Korea Co., Ltd.
2023-03-13
Number 40-2-ND
Changzhou SynTheAll Pharm...
China
No. 589 North Yulong Road...
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Looking for 1000025-07-9 / Vadadustat API manufacturers, exporters & distributors?

Vadadustat manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Vadadustat

Synonyms

1000025-07-9, Akb-6548, Pg-1016548, Vadadustat [usan], N-(5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl)glycine, B506

Cas Number

1000025-07-9

Unique Ingredient Identifier (UNII)

I60W9520VV

About Vadadustat

Vadadustat is an orally bioavailable, hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor (HIF-PHI), with potential anti-anemic and anti-inflammatory activities. Upon administration, vadadustat binds to and inhibits HIF-PH, 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. In addition, HIF 1-alpha (HIF1A) may play a role in reducing inflammation during acute lung injury (ALI) through HIF-dependent control of glucose metabolism in the alveolar epithelium.

Vadadustat Manufacturers

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

Vadadustat Suppliers

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

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

Vadadustat KDMF

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

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

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

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

Vadadustat Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. Mitsubishi Tanabe Pharma
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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