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Looking for 1356446-42-8 / Grazoprevir API manufacturers, exporters & distributors?

Grazoprevir manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Grazoprevir

Synonyms

1350514-68-9, Mk-5172, Mk5172, Grazoprevir [inn], Mk-5172 anhydrous, Grazoprevir anhydrous

Cas Number

1356446-42-8

Unique Ingredient Identifier (UNII)

8YE81R1X1J

About Grazoprevir

Grazoprevir is a direct acting antiviral medication used as part of combination therapy to treat chronic Hepatitis C, an infectious liver disease caused by infection with Hepatitis C Virus (HCV). HCV is a single-stranded RNA virus that is categorized into nine distinct genotypes, with genotype 1 being the most common in the United States, and affecting 72% of all chronic HCV patients. Treatment options for chronic Hepatitis C have advanced significantly since 2011, with the development of Direct Acting Antivirals (DAAs) such as Grazoprevir. Grazoprevir is an inhibitor of NS3/4A, a serine protease enzyme, encoded by HCV genotypes 1 and 4 [synthesis]. These enzymes are essential for viral replication and serve to cleave the virally encoded polyprotein into mature proteins like NS3, NS4A, NS4B, NS5A and NS5B. The barrier for develoment of resistance to NS3/4A inhibitors is lower than that of NS5B inhibitors, another class of DAAs. Subtitutions at amino acid positions 155, 156, or 168 are known to confer resistance. The substitutions of the enzyme's catalytic triad consisting of H58, D82, and S139 are also likely to alter the affinity of the drug for NS3/4A or the activity of the enzyme itself. Despite this disadvantage Grazoprevir is still effective against HCV particularly when paired with [DB11574]. In a joint recommendation published in 2016, the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) recommend Grazoprevir as first line therapy in combination with [DB11574] for genotypes 1a, 1b, and 4 of Hepatitis C. Grazoprevir and [DB11574] are used with or without [DB00811] with the intent to cure, or achieve a sustained virologic response (SVR), after 12 weeks of daily therapy. SVR and eradication of HCV infection is associated with significant long-term health benefits including reduced liver-related damage, improved quality of life, reduced incidence of Hepatocellular Carcinoma, and reduced all-cause mortality. Grazoprevir is available as a fixed dose combination product with [DB11574] (tradename Zepatier) used for the treatment of chronic Hepatitis C. Approved in January 2016 by the FDA, Zepatier is indicated for the treatment of HCV genotypes 1 and 4 with or without [DB00811] depending on the the presence of resistance associated amino acid substitutions in the NS5A protein and previous treatment failure with [DB00811], [DB00008], [DB00022], or other NS3/4A inhibitors like [DB08873], [DB06290], or [DB05521]. When combined together, Grazoprevir and [DB11574] as the combination product Zepatier have been shown to achieve a SVR between 94% and 97% for genotype 1 and 97% and 100% for genotype 4 after 12 weeks of treatment. It can be used in patients with compensated cirrhosis, human immunodeficiency virus co-infection, or severe kidney disease.

Grazoprevir Manufacturers

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

Grazoprevir Suppliers

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

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

Grazoprevir KDMF

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

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

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

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

Grazoprevir NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Grazoprevir as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Grazoprevir API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Grazoprevir as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Grazoprevir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Grazoprevir NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Grazoprevir suppliers with NDC on PharmaCompass.

Grazoprevir GMP

Grazoprevir Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Grazoprevir GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Grazoprevir GMP manufacturer or Grazoprevir GMP API supplier for your needs.

Grazoprevir CoA

A Grazoprevir CoA (Certificate of Analysis) is a formal document that attests to Grazoprevir's compliance with Grazoprevir specifications and serves as a tool for batch-level quality control.

Grazoprevir CoA mostly includes findings from lab analyses of a specific batch. For each Grazoprevir CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Grazoprevir may be tested according to a variety of international standards, such as European Pharmacopoeia (Grazoprevir EP), Grazoprevir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Grazoprevir USP).

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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