X
API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
Other Suppliers
USA (Orange Book)
Europe
Canada
Australia
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
77
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.
A Emtricitabine and tenofovir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Emtricitabine and tenofovir, including repackagers and relabelers. The FDA regulates Emtricitabine and tenofovir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Emtricitabine and tenofovir 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 Emtricitabine and tenofovir manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Emtricitabine and tenofovir supplier is an individual or a company that provides Emtricitabine and tenofovir active pharmaceutical ingredient (API) or Emtricitabine and tenofovir finished formulations upon request. The Emtricitabine and tenofovir suppliers may include Emtricitabine and tenofovir API manufacturers, exporters, distributors and traders.
click here to find a list of Emtricitabine and tenofovir suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Emtricitabine and tenofovir DMF (Drug Master File) is a document detailing the whole manufacturing process of Emtricitabine and tenofovir active pharmaceutical ingredient (API) in detail. Different forms of Emtricitabine and tenofovir DMFs exist exist since differing nations have different regulations, such as Emtricitabine and tenofovir USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Emtricitabine and tenofovir DMF submitted to regulatory agencies in the US is known as a USDMF. Emtricitabine and tenofovir USDMF includes data on Emtricitabine and tenofovir's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Emtricitabine and tenofovir USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Emtricitabine and tenofovir suppliers with USDMF on PharmaCompass.
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 Emtricitabine and tenofovir Drug Master File in Japan (Emtricitabine and tenofovir JDMF) empowers Emtricitabine and tenofovir 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 Emtricitabine and tenofovir JDMF during the approval evaluation for pharmaceutical products. At the time of Emtricitabine and tenofovir 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 Emtricitabine and tenofovir suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Emtricitabine and tenofovir Drug Master File in Korea (Emtricitabine and tenofovir KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Emtricitabine and tenofovir. The MFDS reviews the Emtricitabine and tenofovir KDMF as part of the drug registration process and uses the information provided in the Emtricitabine and tenofovir KDMF to evaluate the safety and efficacy of the drug.
After submitting a Emtricitabine and tenofovir 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 Emtricitabine and tenofovir API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Emtricitabine and tenofovir suppliers with KDMF on PharmaCompass.
A Emtricitabine and tenofovir written confirmation (Emtricitabine and tenofovir WC) is an official document issued by a regulatory agency to a Emtricitabine and tenofovir manufacturer, verifying that the manufacturing facility of a Emtricitabine and tenofovir active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Emtricitabine and tenofovir APIs or Emtricitabine and tenofovir finished pharmaceutical products to another nation, regulatory agencies frequently require a Emtricitabine and tenofovir WC (written confirmation) as part of the regulatory process.
click here to find a list of Emtricitabine and tenofovir suppliers with Written Confirmation (WC) on PharmaCompass.
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 Emtricitabine and tenofovir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Emtricitabine and tenofovir API and other APIs are published in this directory by the FDA.
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 Emtricitabine and tenofovir 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.
The NDC directory also contains data on finished compounded human drug products that contain Emtricitabine and tenofovir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Emtricitabine and tenofovir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Emtricitabine and tenofovir suppliers with NDC on PharmaCompass.
Emtricitabine and tenofovir 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 Emtricitabine and tenofovir 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 Emtricitabine and tenofovir GMP manufacturer or Emtricitabine and tenofovir GMP API supplier for your needs.
A Emtricitabine and tenofovir CoA (Certificate of Analysis) is a formal document that attests to Emtricitabine and tenofovir's compliance with Emtricitabine and tenofovir specifications and serves as a tool for batch-level quality control.
Emtricitabine and tenofovir CoA mostly includes findings from lab analyses of a specific batch. For each Emtricitabine and tenofovir 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.
Emtricitabine and tenofovir may be tested according to a variety of international standards, such as European Pharmacopoeia (Emtricitabine and tenofovir EP), Emtricitabine and tenofovir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Emtricitabine and tenofovir USP).
Market Place
