Synopsis
Synopsis
0
VMF
DRUG PRODUCT COMPOSITIONS0
FDF
0
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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**Fe...DOSAGE - POWDER;INHALATION - 0.012MG/INH **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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PharmaCompass offers a list of Formoterol Fumarate 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 Formoterol Fumarate manufacturer or Formoterol Fumarate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Formoterol Fumarate manufacturer or Formoterol Fumarate supplier.
PharmaCompass also assists you with knowing the Formoterol Fumarate API Price utilized in the formulation of products. Formoterol Fumarate API Price is not always fixed or binding as the Formoterol Fumarate Price is obtained through a variety of data sources. The Formoterol Fumarate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dulera manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dulera, including repackagers and relabelers. The FDA regulates Dulera manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dulera 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 Dulera manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dulera supplier is an individual or a company that provides Dulera active pharmaceutical ingredient (API) or Dulera finished formulations upon request. The Dulera suppliers may include Dulera API manufacturers, exporters, distributors and traders.
click here to find a list of Dulera suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dulera DMF (Drug Master File) is a document detailing the whole manufacturing process of Dulera active pharmaceutical ingredient (API) in detail. Different forms of Dulera DMFs exist exist since differing nations have different regulations, such as Dulera USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dulera DMF submitted to regulatory agencies in the US is known as a USDMF. Dulera USDMF includes data on Dulera's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dulera USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dulera 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 Dulera Drug Master File in Japan (Dulera JDMF) empowers Dulera 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 Dulera JDMF during the approval evaluation for pharmaceutical products. At the time of Dulera 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 Dulera 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 Dulera Drug Master File in Korea (Dulera KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dulera. The MFDS reviews the Dulera KDMF as part of the drug registration process and uses the information provided in the Dulera KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dulera 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 Dulera API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dulera suppliers with KDMF on PharmaCompass.
A Dulera CEP of the European Pharmacopoeia monograph is often referred to as a Dulera Certificate of Suitability (COS). The purpose of a Dulera CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dulera EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dulera to their clients by showing that a Dulera CEP has been issued for it. The manufacturer submits a Dulera CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dulera CEP holder for the record. Additionally, the data presented in the Dulera CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dulera DMF.
A Dulera CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dulera 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 Dulera suppliers with CEP (COS) on PharmaCompass.
A Dulera written confirmation (Dulera WC) is an official document issued by a regulatory agency to a Dulera manufacturer, verifying that the manufacturing facility of a Dulera active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Dulera APIs or Dulera finished pharmaceutical products to another nation, regulatory agencies frequently require a Dulera WC (written confirmation) as part of the regulatory process.
click here to find a list of Dulera 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 Dulera as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dulera 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 Dulera 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 Dulera and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dulera NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dulera suppliers with NDC on PharmaCompass.
Dulera 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 Dulera 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 Dulera GMP manufacturer or Dulera GMP API supplier for your needs.
A Dulera CoA (Certificate of Analysis) is a formal document that attests to Dulera's compliance with Dulera specifications and serves as a tool for batch-level quality control.
Dulera CoA mostly includes findings from lab analyses of a specific batch. For each Dulera 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.
Dulera may be tested according to a variety of international standards, such as European Pharmacopoeia (Dulera EP), Dulera JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dulera USP).
