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