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DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL
USFDA APPLICATION NUMBER - 200796
DOSAGE - TABLET;ORAL - EQ 80MG MEDOXOMIL
USFDA APPLICATION NUMBER - 200796
DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5...DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;12.5MG
USFDA APPLICATION NUMBER - 202331
DOSAGE - TABLET;ORAL - EQ 40MG MEDOXOMIL;25MG
USFDA APPLICATION NUMBER - 202331
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PharmaCompass offers a list of Azilsartan 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 Azilsartan manufacturer or Azilsartan supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Azilsartan manufacturer or Azilsartan supplier.
PharmaCompass also assists you with knowing the Azilsartan API Price utilized in the formulation of products. Azilsartan API Price is not always fixed or binding as the Azilsartan Price is obtained through a variety of data sources. The Azilsartan Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Azilsartan Medoxomil Potassium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azilsartan Medoxomil Potassium, including repackagers and relabelers. The FDA regulates Azilsartan Medoxomil Potassium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azilsartan Medoxomil Potassium supplier is an individual or a company that provides Azilsartan Medoxomil Potassium active pharmaceutical ingredient (API) or Azilsartan Medoxomil Potassium finished formulations upon request. The Azilsartan Medoxomil Potassium suppliers may include Azilsartan Medoxomil Potassium API manufacturers, exporters, distributors and traders.
click here to find a list of Azilsartan Medoxomil Potassium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azilsartan Medoxomil Potassium DMF (Drug Master File) is a document detailing the whole manufacturing process of Azilsartan Medoxomil Potassium active pharmaceutical ingredient (API) in detail. Different forms of Azilsartan Medoxomil Potassium DMFs exist exist since differing nations have different regulations, such as Azilsartan Medoxomil Potassium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azilsartan Medoxomil Potassium DMF submitted to regulatory agencies in the US is known as a USDMF. Azilsartan Medoxomil Potassium USDMF includes data on Azilsartan Medoxomil Potassium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azilsartan Medoxomil Potassium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium Drug Master File in Japan (Azilsartan Medoxomil Potassium JDMF) empowers Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium JDMF during the approval evaluation for pharmaceutical products. At the time of Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium Drug Master File in Korea (Azilsartan Medoxomil Potassium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Azilsartan Medoxomil Potassium. The MFDS reviews the Azilsartan Medoxomil Potassium KDMF as part of the drug registration process and uses the information provided in the Azilsartan Medoxomil Potassium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Azilsartan Medoxomil Potassium suppliers with KDMF on PharmaCompass.
A Azilsartan Medoxomil Potassium written confirmation (Azilsartan Medoxomil Potassium WC) is an official document issued by a regulatory agency to a Azilsartan Medoxomil Potassium manufacturer, verifying that the manufacturing facility of a Azilsartan Medoxomil Potassium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Azilsartan Medoxomil Potassium APIs or Azilsartan Medoxomil Potassium finished pharmaceutical products to another nation, regulatory agencies frequently require a Azilsartan Medoxomil Potassium WC (written confirmation) as part of the regulatory process.
click here to find a list of Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azilsartan Medoxomil Potassium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Azilsartan Medoxomil Potassium suppliers with NDC on PharmaCompass.
Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium 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 Azilsartan Medoxomil Potassium GMP manufacturer or Azilsartan Medoxomil Potassium GMP API supplier for your needs.
A Azilsartan Medoxomil Potassium CoA (Certificate of Analysis) is a formal document that attests to Azilsartan Medoxomil Potassium's compliance with Azilsartan Medoxomil Potassium specifications and serves as a tool for batch-level quality control.
Azilsartan Medoxomil Potassium CoA mostly includes findings from lab analyses of a specific batch. For each Azilsartan Medoxomil Potassium 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.
Azilsartan Medoxomil Potassium may be tested according to a variety of international standards, such as European Pharmacopoeia (Azilsartan Medoxomil Potassium EP), Azilsartan Medoxomil Potassium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azilsartan Medoxomil Potassium USP).
