X
API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
Europe
Canada
0
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
Annual Reports
0
24
PharmaCompass offers a list of Tinidazole 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 Tinidazole manufacturer or Tinidazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tinidazole manufacturer or Tinidazole supplier.
PharmaCompass also assists you with knowing the Tinidazole API Price utilized in the formulation of products. Tinidazole API Price is not always fixed or binding as the Tinidazole Price is obtained through a variety of data sources. The Tinidazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 033KF7V46H manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 033KF7V46H, including repackagers and relabelers. The FDA regulates 033KF7V46H manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 033KF7V46H 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 033KF7V46H manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 033KF7V46H supplier is an individual or a company that provides 033KF7V46H active pharmaceutical ingredient (API) or 033KF7V46H finished formulations upon request. The 033KF7V46H suppliers may include 033KF7V46H API manufacturers, exporters, distributors and traders.
click here to find a list of 033KF7V46H suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 033KF7V46H DMF (Drug Master File) is a document detailing the whole manufacturing process of 033KF7V46H active pharmaceutical ingredient (API) in detail. Different forms of 033KF7V46H DMFs exist exist since differing nations have different regulations, such as 033KF7V46H USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 033KF7V46H DMF submitted to regulatory agencies in the US is known as a USDMF. 033KF7V46H USDMF includes data on 033KF7V46H's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 033KF7V46H USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 033KF7V46H 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 033KF7V46H Drug Master File in Japan (033KF7V46H JDMF) empowers 033KF7V46H 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 033KF7V46H JDMF during the approval evaluation for pharmaceutical products. At the time of 033KF7V46H 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 033KF7V46H suppliers with JDMF on PharmaCompass.
A 033KF7V46H CEP of the European Pharmacopoeia monograph is often referred to as a 033KF7V46H Certificate of Suitability (COS). The purpose of a 033KF7V46H CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of 033KF7V46H EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of 033KF7V46H to their clients by showing that a 033KF7V46H CEP has been issued for it. The manufacturer submits a 033KF7V46H CEP (COS) as part of the market authorization procedure, and it takes on the role of a 033KF7V46H CEP holder for the record. Additionally, the data presented in the 033KF7V46H CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the 033KF7V46H DMF.
A 033KF7V46H CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. 033KF7V46H CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of 033KF7V46H suppliers with CEP (COS) on PharmaCompass.
A 033KF7V46H written confirmation (033KF7V46H WC) is an official document issued by a regulatory agency to a 033KF7V46H manufacturer, verifying that the manufacturing facility of a 033KF7V46H active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 033KF7V46H APIs or 033KF7V46H finished pharmaceutical products to another nation, regulatory agencies frequently require a 033KF7V46H WC (written confirmation) as part of the regulatory process.
click here to find a list of 033KF7V46H 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 033KF7V46H as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 033KF7V46H 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 033KF7V46H 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 033KF7V46H and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 033KF7V46H NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 033KF7V46H suppliers with NDC on PharmaCompass.
033KF7V46H 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 033KF7V46H 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 033KF7V46H GMP manufacturer or 033KF7V46H GMP API supplier for your needs.
A 033KF7V46H CoA (Certificate of Analysis) is a formal document that attests to 033KF7V46H's compliance with 033KF7V46H specifications and serves as a tool for batch-level quality control.
033KF7V46H CoA mostly includes findings from lab analyses of a specific batch. For each 033KF7V46H 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.
033KF7V46H may be tested according to a variety of international standards, such as European Pharmacopoeia (033KF7V46H EP), 033KF7V46H JP (Japanese Pharmacopeia) and the US Pharmacopoeia (033KF7V46H USP).
Market Place
