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API SUPPLIERS
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USDMF
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DOSAGE - POWDER, METERED;INHALATION - 0.4MG/I...DOSAGE - POWDER, METERED;INHALATION - 0.4MG/INH
USFDA APPLICATION NUMBER - 202450
DOSAGE - POWDER, METERED;INHALATION - 0.4MG/I...DOSAGE - POWDER, METERED;INHALATION - 0.4MG/INH;0.012MG/INH
USFDA APPLICATION NUMBER - 210595
Related Excipient Companies
Faran Shimi Pharmaceutical
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
61
PharmaCompass offers a list of Aclidinium Bromide 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 Aclidinium Bromide manufacturer or Aclidinium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aclidinium Bromide manufacturer or Aclidinium Bromide supplier.
PharmaCompass also assists you with knowing the Aclidinium Bromide API Price utilized in the formulation of products. Aclidinium Bromide API Price is not always fixed or binding as the Aclidinium Bromide Price is obtained through a variety of data sources. The Aclidinium Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Bretaris manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bretaris, including repackagers and relabelers. The FDA regulates Bretaris manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bretaris 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 Bretaris manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bretaris supplier is an individual or a company that provides Bretaris active pharmaceutical ingredient (API) or Bretaris finished formulations upon request. The Bretaris suppliers may include Bretaris API manufacturers, exporters, distributors and traders.
click here to find a list of Bretaris suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Bretaris DMF (Drug Master File) is a document detailing the whole manufacturing process of Bretaris active pharmaceutical ingredient (API) in detail. Different forms of Bretaris DMFs exist exist since differing nations have different regulations, such as Bretaris USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Bretaris DMF submitted to regulatory agencies in the US is known as a USDMF. Bretaris USDMF includes data on Bretaris's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bretaris USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Bretaris 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 Bretaris Drug Master File in Japan (Bretaris JDMF) empowers Bretaris 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 Bretaris JDMF during the approval evaluation for pharmaceutical products. At the time of Bretaris 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 Bretaris 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 Bretaris Drug Master File in Korea (Bretaris KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bretaris. The MFDS reviews the Bretaris KDMF as part of the drug registration process and uses the information provided in the Bretaris KDMF to evaluate the safety and efficacy of the drug.
After submitting a Bretaris 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 Bretaris API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Bretaris suppliers with KDMF on PharmaCompass.
A Bretaris written confirmation (Bretaris WC) is an official document issued by a regulatory agency to a Bretaris manufacturer, verifying that the manufacturing facility of a Bretaris active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bretaris APIs or Bretaris finished pharmaceutical products to another nation, regulatory agencies frequently require a Bretaris WC (written confirmation) as part of the regulatory process.
click here to find a list of Bretaris 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 Bretaris as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Bretaris 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 Bretaris 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 Bretaris and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bretaris NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Bretaris suppliers with NDC on PharmaCompass.
Bretaris 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 Bretaris 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 Bretaris GMP manufacturer or Bretaris GMP API supplier for your needs.
A Bretaris CoA (Certificate of Analysis) is a formal document that attests to Bretaris's compliance with Bretaris specifications and serves as a tool for batch-level quality control.
Bretaris CoA mostly includes findings from lab analyses of a specific batch. For each Bretaris 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.
Bretaris may be tested according to a variety of international standards, such as European Pharmacopoeia (Bretaris EP), Bretaris JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bretaris USP).
