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1. Mls001401438
2. Chembl1895091
3. Hms2051p14
4. Hms2233m10
5. Ccg-101038
6. Nc00288
7. Smr000471620
| Molecular Weight | 478.5 g/mol |
|---|---|
| Molecular Formula | C23H30N2O9 |
| Hydrogen Bond Donor Count | 7 |
| Hydrogen Bond Acceptor Count | 10 |
| Rotatable Bond Count | 10 |
| Exact Mass | 478.19513054 g/mol |
| Monoisotopic Mass | 478.19513054 g/mol |
| Topological Polar Surface Area | 166 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 507 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
API SUPPLIERS
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USDMF
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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DOSAGE - POWDER;INHALATION - 0.012MG/INH **Fe...DOSAGE - POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20831
DOSAGE - POWDER, METERED;INHALATION - 0.4MG/I...DOSAGE - POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH
USFDA APPLICATION NUMBER - 210595
DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.08MG/INH;0.0045MG/INH
USFDA APPLICATION NUMBER - 21929
DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG...DOSAGE - AEROSOL, METERED;INHALATION - 0.16MG/INH;0.0045MG/INH
USFDA APPLICATION NUMBER - 21929
DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.05MG/INH
USFDA APPLICATION NUMBER - 22518
DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.1MG/INH
USFDA APPLICATION NUMBER - 22518
DOSAGE - AEROSOL, METERED;INHALATION - 0.005M...DOSAGE - AEROSOL, METERED;INHALATION - 0.005MG/INH;0.2MG/INH
USFDA APPLICATION NUMBER - 22518
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Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Formoterol Fumarate Dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Formoterol Fumarate Dihydrate, including repackagers and relabelers. The FDA regulates Formoterol Fumarate Dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Formoterol Fumarate Dihydrate supplier is an individual or a company that provides Formoterol Fumarate Dihydrate active pharmaceutical ingredient (API) or Formoterol Fumarate Dihydrate finished formulations upon request. The Formoterol Fumarate Dihydrate suppliers may include Formoterol Fumarate Dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Formoterol Fumarate Dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Formoterol Fumarate Dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Formoterol Fumarate Dihydrate active pharmaceutical ingredient (API) in detail. Different forms of Formoterol Fumarate Dihydrate DMFs exist exist since differing nations have different regulations, such as Formoterol Fumarate Dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Formoterol Fumarate Dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Formoterol Fumarate Dihydrate USDMF includes data on Formoterol Fumarate Dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Formoterol Fumarate Dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate Drug Master File in Japan (Formoterol Fumarate Dihydrate JDMF) empowers Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate Drug Master File in Korea (Formoterol Fumarate Dihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Formoterol Fumarate Dihydrate. The MFDS reviews the Formoterol Fumarate Dihydrate KDMF as part of the drug registration process and uses the information provided in the Formoterol Fumarate Dihydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Formoterol Fumarate Dihydrate suppliers with KDMF on PharmaCompass.
A Formoterol Fumarate Dihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Formoterol Fumarate Dihydrate Certificate of Suitability (COS). The purpose of a Formoterol Fumarate Dihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Formoterol Fumarate Dihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Formoterol Fumarate Dihydrate to their clients by showing that a Formoterol Fumarate Dihydrate CEP has been issued for it. The manufacturer submits a Formoterol Fumarate Dihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Formoterol Fumarate Dihydrate CEP holder for the record. Additionally, the data presented in the Formoterol Fumarate Dihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Formoterol Fumarate Dihydrate DMF.
A Formoterol Fumarate Dihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate suppliers with CEP (COS) on PharmaCompass.
A Formoterol Fumarate Dihydrate written confirmation (Formoterol Fumarate Dihydrate WC) is an official document issued by a regulatory agency to a Formoterol Fumarate Dihydrate manufacturer, verifying that the manufacturing facility of a Formoterol Fumarate Dihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Formoterol Fumarate Dihydrate APIs or Formoterol Fumarate Dihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Formoterol Fumarate Dihydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Formoterol Fumarate Dihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Formoterol Fumarate Dihydrate suppliers with NDC on PharmaCompass.
Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate 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 Formoterol Fumarate Dihydrate GMP manufacturer or Formoterol Fumarate Dihydrate GMP API supplier for your needs.
A Formoterol Fumarate Dihydrate CoA (Certificate of Analysis) is a formal document that attests to Formoterol Fumarate Dihydrate's compliance with Formoterol Fumarate Dihydrate specifications and serves as a tool for batch-level quality control.
Formoterol Fumarate Dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Formoterol Fumarate Dihydrate 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.
Formoterol Fumarate Dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Formoterol Fumarate Dihydrate EP), Formoterol Fumarate Dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Formoterol Fumarate Dihydrate USP).
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