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