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Looking for 1256388-51-8 / Ledipasvir API manufacturers, exporters & distributors?

Ledipasvir manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ledipasvir

Synonyms

1256388-51-8, Gs-5885, Gs5885, Ledipasvir acetonate, Gs 5885, Ledipasvir [usan]

Cas Number

1256388-51-8

Unique Ingredient Identifier (UNII)

013TE6E4WV

About Ledipasvir

Ledipasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV. Upon oral administration and after intracellular uptake, ledipasvir binds to and blocks the activity of the NS5A protein. This results in the disruption of the viral RNA replication complex, blockage of HCV RNA production, and inhibition of viral replication. NS5A, a zinc-binding and proline-rich hydrophilic phosphoprotein, plays a crucial role in HCV RNA replication. HCV is a small, enveloped, single-stranded RNA virus belonging to the Flaviviridae family; HCV infection is associated with the development of hepatocellular carcinoma (HCC).

Ledipasvir Manufacturers

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

Ledipasvir Suppliers

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

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

Ledipasvir USDMF

A Ledipasvir DMF (Drug Master File) is a document detailing the whole manufacturing process of Ledipasvir active pharmaceutical ingredient (API) in detail. Different forms of Ledipasvir DMFs exist exist since differing nations have different regulations, such as Ledipasvir USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Ledipasvir DMF submitted to regulatory agencies in the US is known as a USDMF. Ledipasvir USDMF includes data on Ledipasvir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ledipasvir USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Ledipasvir suppliers with USDMF on PharmaCompass.

Ledipasvir KDMF

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

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

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

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

Ledipasvir WC

A Ledipasvir written confirmation (Ledipasvir WC) is an official document issued by a regulatory agency to a Ledipasvir manufacturer, verifying that the manufacturing facility of a Ledipasvir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ledipasvir APIs or Ledipasvir finished pharmaceutical products to another nation, regulatory agencies frequently require a Ledipasvir WC (written confirmation) as part of the regulatory process.

click here to find a list of Ledipasvir suppliers with Written Confirmation (WC) on PharmaCompass.

Ledipasvir 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 Ledipasvir as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ledipasvir 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 Ledipasvir 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 Ledipasvir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ledipasvir NDC to their finished compounded human drug products, they may choose to do so.

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

Ledipasvir GMP

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

Ledipasvir CoA

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

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

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