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Looking for 1190307-88-0 / Sofosbuvir API manufacturers, exporters & distributors?

Sofosbuvir manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Sofosbuvir

Synonyms

Psi-7977, 1190307-88-0, Sovaldi, Gs-7977, Psi 7977, Gs7977

Cas Number

1190307-88-0

Unique Ingredient Identifier (UNII)

WJ6CA3ZU8B

About Sofosbuvir

A uridine monophosphate analog inhibitor of HEPATITIS C VIRUS (HCV) polymerase NS5B that is used as an ANTIVIRAL AGENT in the treatment of CHRONIC HEPATITIS C.

sovaldi Manufacturers

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

sovaldi Suppliers

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

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

sovaldi USDMF

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

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

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

sovaldi KDMF

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

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

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

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

sovaldi WC

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

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

sovaldi 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 sovaldi as an active pharmaceutical ingredient (API).

Finished drug products

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

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

sovaldi GMP

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

sovaldi CoA

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

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

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