Close
4

Quotient Sciences Quotient Sciences

X

Find Pibrentasvir 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

0

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

0

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 1353900-92-1 / Pibrentasvir API manufacturers, exporters & distributors?

Pibrentasvir manufacturers, exporters & distributors 1

76

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

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

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

API | Excipient name

Pibrentasvir

Synonyms

1353900-92-1, Abt-530, Pibrentasvir [usan], Abt 530, A-1325912.0, Abt530

Cas Number

1353900-92-1

Unique Ingredient Identifier (UNII)

2WU922TK3L

About Pibrentasvir

Pibrentasvir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS5A inhibitor that targets the the viral RNA replication and viron assembly. In combination with [DB13879], pibrentastiv is a useful therapy for patients who experienced therapeutic failure from other NS5A inhibitors. In cell cultures, the emergence of amino acid substitutions at known NS5A inhibitor resistance-associated positions in HCV genotype 1a, 2a or 3a replicons led to reduced susceptibility and resistance to pibrentasvir. These resistance-associated amino acid substitutions included Q30D/deletion, Y93D/H/N or H58D +Y93H in genotype 1a replicons, F28S + M31I or P29S + K30G in genotype 2a replicons, and Y93H in genotype 3a replicons. Individual NS5A amino acid substitutions that reduced susceptibility to pibrentasvir include M28G or Q30D in a genotype 1a replicon and P32-deletion in a genotype 1b replicon. Pibrentasvir is available as an oral combination therapy with [DB13879] 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.

Pibrentasvir Manufacturers

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

Pibrentasvir Suppliers

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

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

Pibrentasvir KDMF

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

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

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

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

Pibrentasvir GMP

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

Pibrentasvir CoA

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

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

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