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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 Tinidazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tinidazole, including repackagers and relabelers. The FDA regulates Tinidazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tinidazole 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 Tinidazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tinidazole supplier is an individual or a company that provides Tinidazole active pharmaceutical ingredient (API) or Tinidazole finished formulations upon request. The Tinidazole suppliers may include Tinidazole API manufacturers, exporters, distributors and traders.
click here to find a list of Tinidazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tinidazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Tinidazole active pharmaceutical ingredient (API) in detail. Different forms of Tinidazole DMFs exist exist since differing nations have different regulations, such as Tinidazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tinidazole DMF submitted to regulatory agencies in the US is known as a USDMF. Tinidazole USDMF includes data on Tinidazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tinidazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tinidazole 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 Tinidazole Drug Master File in Japan (Tinidazole JDMF) empowers Tinidazole 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 Tinidazole JDMF during the approval evaluation for pharmaceutical products. At the time of Tinidazole 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 Tinidazole suppliers with JDMF on PharmaCompass.
A Tinidazole CEP of the European Pharmacopoeia monograph is often referred to as a Tinidazole Certificate of Suitability (COS). The purpose of a Tinidazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tinidazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tinidazole to their clients by showing that a Tinidazole CEP has been issued for it. The manufacturer submits a Tinidazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tinidazole CEP holder for the record. Additionally, the data presented in the Tinidazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tinidazole DMF.
A Tinidazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tinidazole 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 Tinidazole suppliers with CEP (COS) on PharmaCompass.
A Tinidazole written confirmation (Tinidazole WC) is an official document issued by a regulatory agency to a Tinidazole manufacturer, verifying that the manufacturing facility of a Tinidazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tinidazole APIs or Tinidazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Tinidazole WC (written confirmation) as part of the regulatory process.
click here to find a list of Tinidazole 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 Tinidazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tinidazole 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 Tinidazole 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 Tinidazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tinidazole NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tinidazole suppliers with NDC on PharmaCompass.
Tinidazole 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 Tinidazole 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 Tinidazole GMP manufacturer or Tinidazole GMP API supplier for your needs.
A Tinidazole CoA (Certificate of Analysis) is a formal document that attests to Tinidazole's compliance with Tinidazole specifications and serves as a tool for batch-level quality control.
Tinidazole CoA mostly includes findings from lab analyses of a specific batch. For each Tinidazole 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.
Tinidazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Tinidazole EP), Tinidazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tinidazole USP).