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PharmaCompass offers a list of Losartan Potassium 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 Losartan Potassium manufacturer or Losartan Potassium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Losartan Potassium manufacturer or Losartan Potassium supplier.
PharmaCompass also assists you with knowing the Losartan Potassium API Price utilized in the formulation of products. Losartan Potassium API Price is not always fixed or binding as the Losartan Potassium Price is obtained through a variety of data sources. The Losartan Potassium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Trityl Losartan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Trityl Losartan, including repackagers and relabelers. The FDA regulates Trityl Losartan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Trityl Losartan 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 Trityl Losartan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Trityl Losartan supplier is an individual or a company that provides Trityl Losartan active pharmaceutical ingredient (API) or Trityl Losartan finished formulations upon request. The Trityl Losartan suppliers may include Trityl Losartan API manufacturers, exporters, distributors and traders.
click here to find a list of Trityl Losartan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Trityl Losartan DMF (Drug Master File) is a document detailing the whole manufacturing process of Trityl Losartan active pharmaceutical ingredient (API) in detail. Different forms of Trityl Losartan DMFs exist exist since differing nations have different regulations, such as Trityl Losartan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Trityl Losartan DMF submitted to regulatory agencies in the US is known as a USDMF. Trityl Losartan USDMF includes data on Trityl Losartan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Trityl Losartan USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Trityl Losartan Drug Master File in Japan (Trityl Losartan JDMF) empowers Trityl Losartan 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 Trityl Losartan JDMF during the approval evaluation for pharmaceutical products. At the time of Trityl Losartan JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Trityl Losartan Drug Master File in Korea (Trityl Losartan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Trityl Losartan. The MFDS reviews the Trityl Losartan KDMF as part of the drug registration process and uses the information provided in the Trityl Losartan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Trityl Losartan 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 Trityl Losartan API can apply through the Korea Drug Master File (KDMF).
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A Trityl Losartan CEP of the European Pharmacopoeia monograph is often referred to as a Trityl Losartan Certificate of Suitability (COS). The purpose of a Trityl Losartan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Trityl Losartan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Trityl Losartan to their clients by showing that a Trityl Losartan CEP has been issued for it. The manufacturer submits a Trityl Losartan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Trityl Losartan CEP holder for the record. Additionally, the data presented in the Trityl Losartan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Trityl Losartan DMF.
A Trityl Losartan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Trityl Losartan 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 Trityl Losartan suppliers with CEP (COS) on PharmaCompass.
A Trityl Losartan written confirmation (Trityl Losartan WC) is an official document issued by a regulatory agency to a Trityl Losartan manufacturer, verifying that the manufacturing facility of a Trityl Losartan active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Trityl Losartan APIs or Trityl Losartan finished pharmaceutical products to another nation, regulatory agencies frequently require a Trityl Losartan WC (written confirmation) as part of the regulatory process.
click here to find a list of Trityl Losartan 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 Trityl Losartan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Trityl Losartan 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 Trityl Losartan 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 Trityl Losartan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Trityl Losartan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Trityl Losartan suppliers with NDC on PharmaCompass.
Trityl Losartan 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 Trityl Losartan 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 Trityl Losartan GMP manufacturer or Trityl Losartan GMP API supplier for your needs.
A Trityl Losartan CoA (Certificate of Analysis) is a formal document that attests to Trityl Losartan's compliance with Trityl Losartan specifications and serves as a tool for batch-level quality control.
Trityl Losartan CoA mostly includes findings from lab analyses of a specific batch. For each Trityl Losartan 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.
Trityl Losartan may be tested according to a variety of international standards, such as European Pharmacopoeia (Trityl Losartan EP), Trityl Losartan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Trityl Losartan USP).
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