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Looking for 1809249-37-3 / Remdesivir API manufacturers, exporters & distributors?

Remdesivir manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Remdesivir

Synonyms

1809249-37-3, 3qki37eehe, Gs 5734, Gs 5734 [who-dd], Gs-5734, Gs5734

Cas Number

1809249-37-3

Unique Ingredient Identifier (UNII)

3QKI37EEHE

About Remdesivir

Remdesivir is a prodrug of an adenosine triphosphate (ATP) analog, with potential antiviral activity against a variety of RNA viruses. Upon administration, remdesivir, being a prodrug, is metabolized into its active form GS-441524. As an ATP analog, GS-441524 competes with ATP for incorporation into RNA and inhibits the action of viral RNA-dependent RNA polymerase. This results in the termination of RNA transcription and decreases viral RNA production.

Remdesivir Manufacturers

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

Remdesivir Suppliers

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

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

Remdesivir USDMF

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

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

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

Remdesivir KDMF

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

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

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

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

Remdesivir 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 Remdesivir as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Remdesivir GMP

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

Remdesivir CoA

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

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

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