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