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API SUPPLIERS
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USDMF
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DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5...DOSAGE - POWDER;INHALATION - 15.6MCG/INH;27.5MCG/INH
USFDA APPLICATION NUMBER - 207930
DOSAGE - POWDER;INHALATION - EQ 75MCG BASE
USFDA APPLICATION NUMBER - 22383
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ABOUT THIS PAGE
A Indacaterol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Indacaterol, including repackagers and relabelers. The FDA regulates Indacaterol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Indacaterol 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 Indacaterol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Indacaterol supplier is an individual or a company that provides Indacaterol active pharmaceutical ingredient (API) or Indacaterol finished formulations upon request. The Indacaterol suppliers may include Indacaterol API manufacturers, exporters, distributors and traders.
click here to find a list of Indacaterol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Indacaterol DMF (Drug Master File) is a document detailing the whole manufacturing process of Indacaterol active pharmaceutical ingredient (API) in detail. Different forms of Indacaterol DMFs exist exist since differing nations have different regulations, such as Indacaterol USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Indacaterol DMF submitted to regulatory agencies in the US is known as a USDMF. Indacaterol USDMF includes data on Indacaterol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Indacaterol USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Indacaterol suppliers with USDMF 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 Indacaterol Drug Master File in Korea (Indacaterol KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Indacaterol. The MFDS reviews the Indacaterol KDMF as part of the drug registration process and uses the information provided in the Indacaterol KDMF to evaluate the safety and efficacy of the drug.
After submitting a Indacaterol 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 Indacaterol API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Indacaterol suppliers with KDMF on PharmaCompass.
A Indacaterol written confirmation (Indacaterol WC) is an official document issued by a regulatory agency to a Indacaterol manufacturer, verifying that the manufacturing facility of a Indacaterol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Indacaterol APIs or Indacaterol finished pharmaceutical products to another nation, regulatory agencies frequently require a Indacaterol WC (written confirmation) as part of the regulatory process.
click here to find a list of Indacaterol 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 Indacaterol as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Indacaterol 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 Indacaterol 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 Indacaterol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Indacaterol NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Indacaterol suppliers with NDC on PharmaCompass.
Indacaterol 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 Indacaterol 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 Indacaterol GMP manufacturer or Indacaterol GMP API supplier for your needs.
A Indacaterol CoA (Certificate of Analysis) is a formal document that attests to Indacaterol's compliance with Indacaterol specifications and serves as a tool for batch-level quality control.
Indacaterol CoA mostly includes findings from lab analyses of a specific batch. For each Indacaterol 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.
Indacaterol may be tested according to a variety of international standards, such as European Pharmacopoeia (Indacaterol EP), Indacaterol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Indacaterol USP).
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