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  • TABLET;ORAL - 200MG;EQ 25MG BASE;300MG
  • TABLET;ORAL - 150MG;150MG;200MG;300MG
  • TABLET;ORAL - 150MG;150MG;200MG;EQ 10MG BASE
  • TABLET;ORAL - 120MG;EQ 15MG BASE
  • TABLET;ORAL - 200MG;EQ 25MG BASE
  • TABLET;ORAL - 200MG;EQ 25MG BASE;EQ 25MG BASE
  • TABLET;ORAL - EQ 30MG BASE;120MG;EQ 15MG BASE
  • TABLET;ORAL - EQ 50MG BASE;200MG;EQ 25MG BASE
  • CAPSULE;ORAL - 200MG
  • TABLET;ORAL - 100MG;150MG
  • TABLET;ORAL - 133MG;200MG
  • TABLET;ORAL - 167MG;250MG
  • TABLET;ORAL - 200MG;300MG

Looking for 143491-57-0 / Emtricitabine API manufacturers, exporters & distributors?

Emtricitabine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Emtricitabine

Synonyms

143491-57-0, Emtriva, Coviracil, (-)-ftc, 4-amino-5-fluoro-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1h)-one, 143491-54-7

Cas Number

143491-57-0

Unique Ingredient Identifier (UNII)

ULS8902U4O

About Emtricitabine

A deoxycytidine analog and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 and HEPATITIS B viruses. It is used to treat HIV INFECTIONS.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine Manufacturers

A 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine, including repackagers and relabelers. The FDA regulates 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine 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 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine Suppliers

A 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine supplier is an individual or a company that provides 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine active pharmaceutical ingredient (API) or 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine finished formulations upon request. The 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine suppliers may include 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine API manufacturers, exporters, distributors and traders.

click here to find a list of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine USDMF

A 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine DMF (Drug Master File) is a document detailing the whole manufacturing process of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine active pharmaceutical ingredient (API) in detail. Different forms of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine DMFs exist exist since differing nations have different regulations, such as 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine DMF submitted to regulatory agencies in the US is known as a USDMF. 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine USDMF includes data on 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine suppliers with USDMF on PharmaCompass.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine Drug Master File in Japan (1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine JDMF) empowers 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine JDMF during the approval evaluation for pharmaceutical products. At the time of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine suppliers with JDMF on PharmaCompass.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine KDMF

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

Pharmaceutical companies submit a 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine Drug Master File in Korea (1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine. The MFDS reviews the 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine KDMF as part of the drug registration process and uses the information provided in the 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine KDMF to evaluate the safety and efficacy of the drug.

After submitting a 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine 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 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine suppliers with KDMF on PharmaCompass.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine WC

A 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine written confirmation (1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine WC) is an official document issued by a regulatory agency to a 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine manufacturer, verifying that the manufacturing facility of a 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine APIs or 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine finished pharmaceutical products to another nation, regulatory agencies frequently require a 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine WC (written confirmation) as part of the regulatory process.

click here to find a list of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine suppliers with Written Confirmation (WC) on PharmaCompass.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine 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 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine 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 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine 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 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine suppliers with NDC on PharmaCompass.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine GMP

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine 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 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine 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 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine GMP manufacturer or 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine GMP API supplier for your needs.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine CoA

A 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine CoA (Certificate of Analysis) is a formal document that attests to 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine's compliance with 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine specifications and serves as a tool for batch-level quality control.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine CoA mostly includes findings from lab analyses of a specific batch. For each 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine 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.

1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine may be tested according to a variety of international standards, such as European Pharmacopoeia (1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine EP), 1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (1-(2-(Hydroxymethyl)oxathiolan-5-yl)-5-fluorocytosine 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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