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PharmaCompass offers a list of Candesartan Cilexetil 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 Candesartan Cilexetil manufacturer or Candesartan Cilexetil supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Candesartan Cilexetil manufacturer or Candesartan Cilexetil supplier.
PharmaCompass also assists you with knowing the Candesartan Cilexetil API Price utilized in the formulation of products. Candesartan Cilexetil API Price is not always fixed or binding as the Candesartan Cilexetil Price is obtained through a variety of data sources. The Candesartan Cilexetil Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER), including repackagers and relabelers. The FDA regulates (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) supplier is an individual or a company that provides (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) active pharmaceutical ingredient (API) or (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) finished formulations upon request. The (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) suppliers may include (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) API manufacturers, exporters, distributors and traders.
click here to find a list of (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) DMF (Drug Master File) is a document detailing the whole manufacturing process of (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) active pharmaceutical ingredient (API) in detail. Different forms of (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) DMFs exist exist since differing nations have different regulations, such as (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) DMF submitted to regulatory agencies in the US is known as a USDMF. (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) USDMF includes data on (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) Drug Master File in Japan ((+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) JDMF) empowers (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) JDMF during the approval evaluation for pharmaceutical products. At the time of (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) Drug Master File in Korea ((+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER). The MFDS reviews the (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) KDMF as part of the drug registration process and uses the information provided in the (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) KDMF to evaluate the safety and efficacy of the drug.
After submitting a (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) API can apply through the Korea Drug Master File (KDMF).
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A (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) CEP of the European Pharmacopoeia monograph is often referred to as a (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) Certificate of Suitability (COS). The purpose of a (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) to their clients by showing that a (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) CEP has been issued for it. The manufacturer submits a (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) CEP (COS) as part of the market authorization procedure, and it takes on the role of a (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) CEP holder for the record. Additionally, the data presented in the (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) DMF.
A (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) written confirmation ((+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) WC) is an official document issued by a regulatory agency to a (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) manufacturer, verifying that the manufacturing facility of a (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) APIs or (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) finished pharmaceutical products to another nation, regulatory agencies frequently require a (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) WC (written confirmation) as part of the regulatory process.
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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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) NDC to their finished compounded human drug products, they may choose to do so.
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(+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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 (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) GMP manufacturer or (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) GMP API supplier for your needs.
A (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) CoA (Certificate of Analysis) is a formal document that attests to (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER)'s compliance with (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) specifications and serves as a tool for batch-level quality control.
(+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) CoA mostly includes findings from lab analyses of a specific batch. For each (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) 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.
(+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) may be tested according to a variety of international standards, such as European Pharmacopoeia ((+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) EP), (+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) JP (Japanese Pharmacopeia) and the US Pharmacopoeia ((+/-)1-HYDROXYETHYL 2-ETHOXY-1-(P-(O-1H-TETRAZOL-5-YLPHENYL)BENZYL)-7-BENZIMIDAZOLECARBOXYLATE, CYCLOHEXYL CARBONATE (ESTER) USP).