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DRUG PRODUCT COMPOSITIONS0
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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**Fe...DOSAGE - POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Formoterol Fumarate, including repackagers and relabelers. The FDA regulates Formoterol Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Formoterol Fumarate 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Formoterol Fumarate supplier is an individual or a company that provides Formoterol Fumarate active pharmaceutical ingredient (API) or Formoterol Fumarate finished formulations upon request. The Formoterol Fumarate suppliers may include Formoterol Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Formoterol Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Formoterol Fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Formoterol Fumarate active pharmaceutical ingredient (API) in detail. Different forms of Formoterol Fumarate DMFs exist exist since differing nations have different regulations, such as Formoterol Fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Formoterol Fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Formoterol Fumarate USDMF includes data on Formoterol Fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Formoterol Fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Formoterol Fumarate 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 Drug Master File in Japan (Formoterol Fumarate JDMF) empowers Formoterol Fumarate 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Formoterol Fumarate 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 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 Drug Master File in Korea (Formoterol Fumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Formoterol Fumarate. The MFDS reviews the Formoterol Fumarate KDMF as part of the drug registration process and uses the information provided in the Formoterol Fumarate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Formoterol Fumarate 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Formoterol Fumarate suppliers with KDMF on PharmaCompass.
A Formoterol Fumarate CEP of the European Pharmacopoeia monograph is often referred to as a Formoterol Fumarate Certificate of Suitability (COS). The purpose of a Formoterol Fumarate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Formoterol Fumarate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Formoterol Fumarate to their clients by showing that a Formoterol Fumarate CEP has been issued for it. The manufacturer submits a Formoterol Fumarate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Formoterol Fumarate CEP holder for the record. Additionally, the data presented in the Formoterol Fumarate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Formoterol Fumarate DMF.
A Formoterol Fumarate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Formoterol Fumarate 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 suppliers with CEP (COS) on PharmaCompass.
A Formoterol Fumarate written confirmation (Formoterol Fumarate WC) is an official document issued by a regulatory agency to a Formoterol Fumarate manufacturer, verifying that the manufacturing facility of a Formoterol Fumarate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Formoterol Fumarate APIs or Formoterol Fumarate finished pharmaceutical products to another nation, regulatory agencies frequently require a Formoterol Fumarate WC (written confirmation) as part of the regulatory process.
click here to find a list of Formoterol Fumarate 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Formoterol Fumarate 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Formoterol Fumarate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Formoterol Fumarate suppliers with NDC on PharmaCompass.
Formoterol Fumarate 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 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 GMP manufacturer or Formoterol Fumarate GMP API supplier for your needs.
A Formoterol Fumarate CoA (Certificate of Analysis) is a formal document that attests to Formoterol Fumarate's compliance with Formoterol Fumarate specifications and serves as a tool for batch-level quality control.
Formoterol Fumarate CoA mostly includes findings from lab analyses of a specific batch. For each Formoterol Fumarate 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Formoterol Fumarate EP), Formoterol Fumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Formoterol Fumarate USP).
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