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API SUPPLIERS
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USDMF
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DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH
USFDA APPLICATION NUMBER - 20503
DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE...DOSAGE - SOLUTION;INHALATION - EQ 0.083% BASE;0.017% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20950
DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH
USFDA APPLICATION NUMBER - 20983
DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.0...DOSAGE - AEROSOL, METERED;INHALATION - EQ 0.09MG BASE/INH
USFDA APPLICATION NUMBER - 21457
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Salbutamol Sulphate 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 Salbutamol Sulphate manufacturer or Salbutamol Sulphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Salbutamol Sulphate manufacturer or Salbutamol Sulphate supplier.
PharmaCompass also assists you with knowing the Salbutamol Sulphate API Price utilized in the formulation of products. Salbutamol Sulphate API Price is not always fixed or binding as the Salbutamol Sulphate Price is obtained through a variety of data sources. The Salbutamol Sulphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Aerolin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aerolin, including repackagers and relabelers. The FDA regulates Aerolin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aerolin 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 Aerolin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aerolin supplier is an individual or a company that provides Aerolin active pharmaceutical ingredient (API) or Aerolin finished formulations upon request. The Aerolin suppliers may include Aerolin API manufacturers, exporters, distributors and traders.
click here to find a list of Aerolin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aerolin DMF (Drug Master File) is a document detailing the whole manufacturing process of Aerolin active pharmaceutical ingredient (API) in detail. Different forms of Aerolin DMFs exist exist since differing nations have different regulations, such as Aerolin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aerolin DMF submitted to regulatory agencies in the US is known as a USDMF. Aerolin USDMF includes data on Aerolin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aerolin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Aerolin 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 Aerolin Drug Master File in Japan (Aerolin JDMF) empowers Aerolin 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 Aerolin JDMF during the approval evaluation for pharmaceutical products. At the time of Aerolin 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 Aerolin 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 Aerolin Drug Master File in Korea (Aerolin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aerolin. The MFDS reviews the Aerolin KDMF as part of the drug registration process and uses the information provided in the Aerolin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aerolin 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 Aerolin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Aerolin suppliers with KDMF on PharmaCompass.
A Aerolin CEP of the European Pharmacopoeia monograph is often referred to as a Aerolin Certificate of Suitability (COS). The purpose of a Aerolin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aerolin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aerolin to their clients by showing that a Aerolin CEP has been issued for it. The manufacturer submits a Aerolin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aerolin CEP holder for the record. Additionally, the data presented in the Aerolin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aerolin DMF.
A Aerolin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aerolin 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 Aerolin suppliers with CEP (COS) on PharmaCompass.
A Aerolin written confirmation (Aerolin WC) is an official document issued by a regulatory agency to a Aerolin manufacturer, verifying that the manufacturing facility of a Aerolin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aerolin APIs or Aerolin finished pharmaceutical products to another nation, regulatory agencies frequently require a Aerolin WC (written confirmation) as part of the regulatory process.
click here to find a list of Aerolin 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 Aerolin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aerolin 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 Aerolin 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 Aerolin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aerolin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Aerolin suppliers with NDC on PharmaCompass.
Aerolin 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 Aerolin 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 Aerolin GMP manufacturer or Aerolin GMP API supplier for your needs.
A Aerolin CoA (Certificate of Analysis) is a formal document that attests to Aerolin's compliance with Aerolin specifications and serves as a tool for batch-level quality control.
Aerolin CoA mostly includes findings from lab analyses of a specific batch. For each Aerolin 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.
Aerolin may be tested according to a variety of international standards, such as European Pharmacopoeia (Aerolin EP), Aerolin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aerolin USP).
