Close
4

Seqens Seqens

X

Find Glecaprevir manufacturers, exporters & distributors on PharmaCompass

PharmaCompass
API SUPPLIERS
API Suppliers

API Suppliers

US DMFs Filed

US DMFs Filed

0

CEP/COS Certifications

CEP/COS Certifications

0

JDMFs Filed

JDMFs Filed

0

Other Certificates

Other Certificates

0

Other Suppliers

Other Suppliers

API REF. PRICE (USD / KG)
INTERMEDIATES
DOSSIERS // FDF
USA (Orange Book)

USA (Orange Book)

Europe

Europe

0

Canada

Canada

Australia

Australia

South Africa

South Africa

0

Uploaded Dossiers

Uploaded Dossiers

0

GLOBAL SALES (USD Million)

U.S. Medicaid

0

Annual Reports

EXCIPIENTS
PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

USFDA Exclusivities

DIGITAL CONTENT

Blog #PharmaFlow

News

REF STANDARD

EDQM

0

USP

0

JP

0

Other Listed Suppliers

0

SERVICES

0

Looking for 1365970-03-1 / Glecaprevir API manufacturers, exporters & distributors?

Glecaprevir manufacturers, exporters & distributors 1

53

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

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

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

API | Excipient name

Glecaprevir

Synonyms

Abt-493, Glecaprevir [usan], 1365970-03-1, A-1282576.0, K6buu8j72p, A-1282576

Cas Number

1365970-03-1

Unique Ingredient Identifier (UNII)

K6BUU8J72P

About Glecaprevir

Glecaprevir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS3/4A protease inhibitor that targets the the viral RNA replication. In combination with [DB13878], glecaprevir is a useful therapy for patients who experienced therapeutic failure from other NS3/4A protease inhibitors. It demonstrates a high genetic barrier against resistance mutations of the virus. In cell cultures, the emergence of amino acid substitutions at NS3 resistance-associated positions A156 or D/Q168 in HCV genotype 1a, 2a or 3a replicons led to reduced susceptibility to glecaprevir. The combinations of amino acid substitutions at NS3 position Y65H and D/Q168 also results in greater reductions in glecaprevir susceptibility, and NS3 Q80R in genotype 3a patients also leads to glecaprevir resistance. Glecaprevir is available as an oral combination therapy with [DB13878] under the brand name Mavyret. This fixed-dose combination therapy was FDA-approved in August 2017 to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also indicated for HCV genotype 1-infected patients who have been previously treated with regimens either containing an NS5A inhibitor or an NS3/4A protease inhibitor, but not both. Hepatitis C viral infection often leads to decreased liver function and subsequent liver failure, causing a significantly negative impact on the patients' quality of life. The ultimate goal of the combination treatment is to achieve sustained virologic response (SVR) and cure the patients from the infection. In clinical trials, this combination therapy achieved SVR12 rate, or undetectable Hepatitis C for twelve or more weeks after the end of treatment, of 93% across genotypes 1a, 2a, 3a, 4, 5 and 6.

Glecaprevir Manufacturers

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

Glecaprevir Suppliers

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

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

Glecaprevir KDMF

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

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

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

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

Glecaprevir GMP

Glecaprevir 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 Glecaprevir 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 Glecaprevir GMP manufacturer or Glecaprevir GMP API supplier for your needs.

Glecaprevir CoA

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

Glecaprevir CoA mostly includes findings from lab analyses of a specific batch. For each Glecaprevir 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.

Glecaprevir may be tested according to a variety of international standards, such as European Pharmacopoeia (Glecaprevir EP), Glecaprevir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Glecaprevir 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty
Post Enquiry
POST ENQUIRY