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