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DOSAGE - POWDER;INHALATION - EQ 0.0625MG BASE...DOSAGE - POWDER;INHALATION - EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH
USFDA APPLICATION NUMBER - 203975
DOSAGE - POWDER;INHALATION - 0.05MG/INH;EQ 0....DOSAGE - POWDER;INHALATION - 0.05MG/INH;EQ 0.025MG BASE/INH
USFDA APPLICATION NUMBER - 204275
DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.1MG/INH;EQ 0.025MG BASE/INH
USFDA APPLICATION NUMBER - 204275
DOSAGE - POWDER;INHALATION - 0.2MG/INH;EQ 0.0...DOSAGE - POWDER;INHALATION - 0.2MG/INH;EQ 0.025MG BASE/INH
USFDA APPLICATION NUMBER - 204275
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ABOUT THIS PAGE
A Vilanterol Trifenatate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vilanterol Trifenatate, including repackagers and relabelers. The FDA regulates Vilanterol Trifenatate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vilanterol Trifenatate 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 Vilanterol Trifenatate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vilanterol Trifenatate supplier is an individual or a company that provides Vilanterol Trifenatate active pharmaceutical ingredient (API) or Vilanterol Trifenatate finished formulations upon request. The Vilanterol Trifenatate suppliers may include Vilanterol Trifenatate API manufacturers, exporters, distributors and traders.
click here to find a list of Vilanterol Trifenatate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vilanterol Trifenatate DMF (Drug Master File) is a document detailing the whole manufacturing process of Vilanterol Trifenatate active pharmaceutical ingredient (API) in detail. Different forms of Vilanterol Trifenatate DMFs exist exist since differing nations have different regulations, such as Vilanterol Trifenatate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vilanterol Trifenatate DMF submitted to regulatory agencies in the US is known as a USDMF. Vilanterol Trifenatate USDMF includes data on Vilanterol Trifenatate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vilanterol Trifenatate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vilanterol Trifenatate 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 Vilanterol Trifenatate Drug Master File in Korea (Vilanterol Trifenatate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vilanterol Trifenatate. The MFDS reviews the Vilanterol Trifenatate KDMF as part of the drug registration process and uses the information provided in the Vilanterol Trifenatate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vilanterol Trifenatate 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 Vilanterol Trifenatate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vilanterol Trifenatate suppliers with KDMF on PharmaCompass.
A Vilanterol Trifenatate written confirmation (Vilanterol Trifenatate WC) is an official document issued by a regulatory agency to a Vilanterol Trifenatate manufacturer, verifying that the manufacturing facility of a Vilanterol Trifenatate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vilanterol Trifenatate APIs or Vilanterol Trifenatate finished pharmaceutical products to another nation, regulatory agencies frequently require a Vilanterol Trifenatate WC (written confirmation) as part of the regulatory process.
click here to find a list of Vilanterol Trifenatate 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 Vilanterol Trifenatate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vilanterol Trifenatate 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 Vilanterol Trifenatate 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 Vilanterol Trifenatate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vilanterol Trifenatate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vilanterol Trifenatate suppliers with NDC on PharmaCompass.
Vilanterol Trifenatate 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 Vilanterol Trifenatate 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 Vilanterol Trifenatate GMP manufacturer or Vilanterol Trifenatate GMP API supplier for your needs.
A Vilanterol Trifenatate CoA (Certificate of Analysis) is a formal document that attests to Vilanterol Trifenatate's compliance with Vilanterol Trifenatate specifications and serves as a tool for batch-level quality control.
Vilanterol Trifenatate CoA mostly includes findings from lab analyses of a specific batch. For each Vilanterol Trifenatate 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.
Vilanterol Trifenatate may be tested according to a variety of international standards, such as European Pharmacopoeia (Vilanterol Trifenatate EP), Vilanterol Trifenatate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vilanterol Trifenatate USP).
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