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VMF
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South Africa
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DRUG PRODUCT COMPOSITIONS0
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Weekly News Recap #Phispers
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
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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 Eklira genuair (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eklira genuair (TN), including repackagers and relabelers. The FDA regulates Eklira genuair (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eklira genuair (TN) 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 Eklira genuair (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eklira genuair (TN) supplier is an individual or a company that provides Eklira genuair (TN) active pharmaceutical ingredient (API) or Eklira genuair (TN) finished formulations upon request. The Eklira genuair (TN) suppliers may include Eklira genuair (TN) API manufacturers, exporters, distributors and traders.
click here to find a list of Eklira genuair (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eklira genuair (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Eklira genuair (TN) active pharmaceutical ingredient (API) in detail. Different forms of Eklira genuair (TN) DMFs exist exist since differing nations have different regulations, such as Eklira genuair (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eklira genuair (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Eklira genuair (TN) USDMF includes data on Eklira genuair (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eklira genuair (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eklira genuair (TN) 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 Eklira genuair (TN) Drug Master File in Japan (Eklira genuair (TN) JDMF) empowers Eklira genuair (TN) 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 Eklira genuair (TN) JDMF during the approval evaluation for pharmaceutical products. At the time of Eklira genuair (TN) 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 Eklira genuair (TN) 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 Eklira genuair (TN) Drug Master File in Korea (Eklira genuair (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eklira genuair (TN). The MFDS reviews the Eklira genuair (TN) KDMF as part of the drug registration process and uses the information provided in the Eklira genuair (TN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eklira genuair (TN) 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 Eklira genuair (TN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eklira genuair (TN) suppliers with KDMF on PharmaCompass.
A Eklira genuair (TN) written confirmation (Eklira genuair (TN) WC) is an official document issued by a regulatory agency to a Eklira genuair (TN) manufacturer, verifying that the manufacturing facility of a Eklira genuair (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eklira genuair (TN) APIs or Eklira genuair (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Eklira genuair (TN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Eklira genuair (TN) 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 Eklira genuair (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eklira genuair (TN) 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 Eklira genuair (TN) 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 Eklira genuair (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eklira genuair (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eklira genuair (TN) suppliers with NDC on PharmaCompass.
Eklira genuair (TN) 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 Eklira genuair (TN) 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 Eklira genuair (TN) GMP manufacturer or Eklira genuair (TN) GMP API supplier for your needs.
A Eklira genuair (TN) CoA (Certificate of Analysis) is a formal document that attests to Eklira genuair (TN)'s compliance with Eklira genuair (TN) specifications and serves as a tool for batch-level quality control.
Eklira genuair (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Eklira genuair (TN) 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.
Eklira genuair (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Eklira genuair (TN) EP), Eklira genuair (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eklira genuair (TN) USP).
