API Suppliers
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
Other Suppliers
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
61
PharmaCompass offers a list of Tenofovir Disoproxil Succinate 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 Tenofovir Disoproxil Succinate manufacturer or Tenofovir Disoproxil Succinate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tenofovir Disoproxil Succinate manufacturer or Tenofovir Disoproxil Succinate supplier.
PharmaCompass also assists you with knowing the Tenofovir Disoproxil Succinate API Price utilized in the formulation of products. Tenofovir Disoproxil Succinate API Price is not always fixed or binding as the Tenofovir Disoproxil Succinate Price is obtained through a variety of data sources. The Tenofovir Disoproxil Succinate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tenofovir Disoproxil Orotate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tenofovir Disoproxil Orotate, including repackagers and relabelers. The FDA regulates Tenofovir Disoproxil Orotate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tenofovir Disoproxil Orotate 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 Tenofovir Disoproxil Orotate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tenofovir Disoproxil Orotate supplier is an individual or a company that provides Tenofovir Disoproxil Orotate active pharmaceutical ingredient (API) or Tenofovir Disoproxil Orotate finished formulations upon request. The Tenofovir Disoproxil Orotate suppliers may include Tenofovir Disoproxil Orotate API manufacturers, exporters, distributors and traders.
click here to find a list of Tenofovir Disoproxil Orotate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Tenofovir Disoproxil Orotate Drug Master File in Korea (Tenofovir Disoproxil Orotate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Tenofovir Disoproxil Orotate. The MFDS reviews the Tenofovir Disoproxil Orotate KDMF as part of the drug registration process and uses the information provided in the Tenofovir Disoproxil Orotate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Tenofovir Disoproxil Orotate 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 Tenofovir Disoproxil Orotate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Tenofovir Disoproxil Orotate suppliers with KDMF on PharmaCompass.
A Tenofovir Disoproxil Orotate written confirmation (Tenofovir Disoproxil Orotate WC) is an official document issued by a regulatory agency to a Tenofovir Disoproxil Orotate manufacturer, verifying that the manufacturing facility of a Tenofovir Disoproxil Orotate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tenofovir Disoproxil Orotate APIs or Tenofovir Disoproxil Orotate finished pharmaceutical products to another nation, regulatory agencies frequently require a Tenofovir Disoproxil Orotate WC (written confirmation) as part of the regulatory process.
click here to find a list of Tenofovir Disoproxil Orotate 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 Tenofovir Disoproxil Orotate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tenofovir Disoproxil Orotate 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 Tenofovir Disoproxil Orotate 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 Tenofovir Disoproxil Orotate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tenofovir Disoproxil Orotate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tenofovir Disoproxil Orotate suppliers with NDC on PharmaCompass.
Tenofovir Disoproxil Orotate 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 Tenofovir Disoproxil Orotate 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 Tenofovir Disoproxil Orotate GMP manufacturer or Tenofovir Disoproxil Orotate GMP API supplier for your needs.
A Tenofovir Disoproxil Orotate CoA (Certificate of Analysis) is a formal document that attests to Tenofovir Disoproxil Orotate's compliance with Tenofovir Disoproxil Orotate specifications and serves as a tool for batch-level quality control.
Tenofovir Disoproxil Orotate CoA mostly includes findings from lab analyses of a specific batch. For each Tenofovir Disoproxil Orotate 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.
Tenofovir Disoproxil Orotate may be tested according to a variety of international standards, such as European Pharmacopoeia (Tenofovir Disoproxil Orotate EP), Tenofovir Disoproxil Orotate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tenofovir Disoproxil Orotate USP).