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1. 863031-24-7
2. Azilsartan (medoxomil Monopotassium)
3. Azilsartan Kamedoxomil
4. Azilsartan Medoxomil Monopotassium
5. Bcp11249
6. Sb19561
7. Hy-17458
8. Potassium;(5-methyl-2-oxo-1,3-dioxol-4-yl)methyl 2-ethoxy-3-[[4-[2-(5-oxo-1-oxa-4-aza-2-azanidacyclopent-3-en-3-yl)phenyl]phenyl]methyl]benzimidazole-4-carboxylate
9. Potassium 3-(4'-((2-ethoxy-7-(((5-methyl-2-oxo-1,3-dioxol-4-yl)methoxy)carbonyl)-1h-benzo[d]imidazol-1-yl)methyl)-[1,1'-biphenyl]-2-yl)-5-oxo-5h-1,2,4-oxadiazol-2-ide
Molecular Weight | 606.6 g/mol |
---|---|
Molecular Formula | C30H23KN4O8 |
Hydrogen Bond Donor Count | 0 |
Hydrogen Bond Acceptor Count | 10 |
Rotatable Bond Count | 10 |
Exact Mass | 606.11529519 g/mol |
Monoisotopic Mass | 606.11529519 g/mol |
Topological Polar Surface Area | 129 Ų |
Heavy Atom Count | 43 |
Formal Charge | 0 |
Complexity | 1110 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-03-14
Registration Number : Su289-30-ND
Manufacturer Name : Shandong Loncom Pharmaceutical Co., Ltd.
Manufacturer Address : No 127, Qizhong Avenue, Yanbei Subdistrict, Qihe County, Dezhou City, Shandong Province,China
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2021-07-13
Registration Number : Su434-15-ND(1)
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-01-04
Pay. Date : 2017-08-08
DMF Number : 31895
Submission : 2017-11-28
Status : Active
Type : II
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0362
Address of the Firm :
NDC Package Code : 69037-0001
Start Marketing Date : 2011-02-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2020-07-09
Registration Number : Su434-15-ND
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City: Karakhadi-391 450, Dist. Vadodara Gujarat State India
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
NDC Package Code : 69037-0032
Start Marketing Date : 2011-02-25
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : Established in May 2012, Shandong Loncom Pharmaceutical operates as a fully owned subsidiary of Shandong Bestcomm Pharmaceutical Co., Ltd. Situated in the Qihe Economic Development...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Azilsartan Medoxomil Potassium
About the Company : Ami Lifesciences, established in 2006, is one of the fastest growing API manufacturing companies in India. Specializing in cardiovascular, anti-diabetic, CNS, and respiratory thera...
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
About the Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our core services include c...
Honour is a leading global CDMO and specialty chemicals manufacturer with seven world-class sites delivering quality-driven solutions.
About the Company : Honour is a leading global CDMO and a trusted manufacturer of specialty chemicals and ingredients. With seven world-class facilities built to meet global safety and quality standar...
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
About the Company : Lupin Manufacturing Solutions (LMS), a wholly owned Lupin subsidiary, offers high-quality APIs and end-to-end CDMO services from R&D to commercial scale. Backed by five decades of ...
About the Company : Chromo Laboratories India Pvt. Ltd, is a Hyderabad based Manufacturer of Intermediates and Active Pharmaceutical Ingredients. The manufacturing facility is located at Pashamylaram...
About the Company : Smilax Laboratories Limited is a research-driven, vertically integrated pharmaceutical company manufacturing Active Pharmaceutical Ingredients, API Intermediates and NDDS/Pellets f...
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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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azilsartan Medoxomil, including repackagers and relabelers. The FDA regulates Azilsartan Medoxomil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azilsartan 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 Azilsartan Medoxomil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Azilsartan Medoxomil supplier is an individual or a company that provides Azilsartan Medoxomil active pharmaceutical ingredient (API) or Azilsartan Medoxomil finished formulations upon request. The Azilsartan Medoxomil suppliers may include Azilsartan Medoxomil API manufacturers, exporters, distributors and traders.
click here to find a list of Azilsartan Medoxomil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Azilsartan Medoxomil DMF (Drug Master File) is a document detailing the whole manufacturing process of Azilsartan Medoxomil active pharmaceutical ingredient (API) in detail. Different forms of Azilsartan Medoxomil DMFs exist exist since differing nations have different regulations, such as Azilsartan Medoxomil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Azilsartan Medoxomil DMF submitted to regulatory agencies in the US is known as a USDMF. Azilsartan Medoxomil USDMF includes data on Azilsartan Medoxomil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Azilsartan Medoxomil 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 Azilsartan Medoxomil Drug Master File in Japan (Azilsartan Medoxomil JDMF) empowers Azilsartan 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 Azilsartan Medoxomil JDMF during the approval evaluation for pharmaceutical products. At the time of Azilsartan 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 Azilsartan 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 Azilsartan Medoxomil Drug Master File in Korea (Azilsartan Medoxomil KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Azilsartan Medoxomil. The MFDS reviews the Azilsartan Medoxomil KDMF as part of the drug registration process and uses the information provided in the Azilsartan Medoxomil KDMF to evaluate the safety and efficacy of the drug.
After submitting a Azilsartan 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 Azilsartan Medoxomil API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Azilsartan Medoxomil suppliers with KDMF on PharmaCompass.
A Azilsartan Medoxomil written confirmation (Azilsartan Medoxomil WC) is an official document issued by a regulatory agency to a Azilsartan Medoxomil manufacturer, verifying that the manufacturing facility of a Azilsartan Medoxomil active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Azilsartan Medoxomil APIs or Azilsartan Medoxomil finished pharmaceutical products to another nation, regulatory agencies frequently require a Azilsartan Medoxomil WC (written confirmation) as part of the regulatory process.
click here to find a list of Azilsartan 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 Azilsartan Medoxomil as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Azilsartan 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 Azilsartan 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 Azilsartan Medoxomil and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Azilsartan Medoxomil NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Azilsartan Medoxomil suppliers with NDC on PharmaCompass.
Azilsartan 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 Azilsartan 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 Azilsartan Medoxomil GMP manufacturer or Azilsartan Medoxomil GMP API supplier for your needs.
A Azilsartan Medoxomil CoA (Certificate of Analysis) is a formal document that attests to Azilsartan Medoxomil's compliance with Azilsartan Medoxomil specifications and serves as a tool for batch-level quality control.
Azilsartan Medoxomil CoA mostly includes findings from lab analyses of a specific batch. For each Azilsartan 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.
Azilsartan Medoxomil may be tested according to a variety of international standards, such as European Pharmacopoeia (Azilsartan Medoxomil EP), Azilsartan Medoxomil JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Azilsartan Medoxomil USP).