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

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01 MSD International GmbH (1)

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01 MSD Korea Co., Ltd. (1)

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01 Boceprevir (1)

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01 U.S.A (1)

URL Supplier Web Content
MSD Korea Co., Ltd.
2014-06-24
Number 3281-14-ND
MSD International GmbH
Singapore
50 Tuas West Drive Singap...
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Looking for 394730-60-0 / Boceprevir API manufacturers, exporters & distributors?

Boceprevir manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Boceprevir

Synonyms

394730-60-0, Victrelis, Sch 503034, Ebp 520, Sch-503034, Sch503034

Cas Number

394730-60-0

Unique Ingredient Identifier (UNII)

89BT58KELH

About Boceprevir

Boceprevir is an orally bioavailable, synthetic tripeptide inhibitor of the nonstructural protein 3 and 4A complex (NS3/NS4A), with potential activity against hepatitis C virus (HCV) genotype 1. Upon administration, boceprevir reversibly binds to the active center of the HCV NS3/NS4A and prevents NS3/NS4A protease-mediated polyprotein maturation. This disrupts the processing of viral proteins and the formation of a viral replication complex, which inhibits viral replication in HCV genotrype 1-infected host cells. NS3, a serine protease, is essential for the proteolytic cleavages within the HCV polyprotein and plays a key role during HCV viral RNA replication. NS4A is an activating factor for NS3. HCV is a small, enveloped, single-stranded RNA virus belonging to the Flaviviridae family.

Boceprevir Manufacturers

A Boceprevir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Boceprevir, including repackagers and relabelers. The FDA regulates Boceprevir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Boceprevir API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Boceprevir Suppliers

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

Boceprevir KDMF

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

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

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

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

Boceprevir Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. Merck & Co
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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