Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
FDF
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
CEP/COS 
EU-WC
NDC
KDMF
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
NDC
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
JDMF
ASMF
Axplora is your partner of choice for complex APIs.
EU
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
EU-WC
NDC
ASMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
CEP/COS
NDC
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
ASMF
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USDMF
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36316
Submission : 2021-10-22
Status :
Type : II
Coral's API range includes Corticosteroids, Antihistamines. Hormones and Antineoplastics.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32040
Submission : 2017-10-02
Status :
Type : II
Vamsi Labs is one of the major manufacturers of Anti-asthmatic, Anti-migraine & Anti-psychotic APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40418
Submission : 2024-08-26
Status :
Type : II
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2015-01-29
Pay. Date : 2014-09-30
DMF Number : 28554
Submission : 2014-09-30
Status :
Type : II
Axplora is your partner of choice for complex APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40090
Submission : 2024-06-13
Status :
Type : II
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33955
Submission : 2020-07-14
Status :
Type : II
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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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
DOSAGE - POWDER;INHALATION - 0.05MG/INH
USFDA APPLICATION NUMBER - 205625
DOSAGE - POWDER;INHALATION - 0.1MG/INH
USFDA APPLICATION NUMBER - 205625
DOSAGE - POWDER;INHALATION - 0.2MG/INH
USFDA APPLICATION NUMBER - 205625
DOSAGE - SPRAY, METERED;NASAL - 0.0275MG/SPRA...DOSAGE - SPRAY, METERED;NASAL - 0.0275MG/SPRAY
USFDA APPLICATION NUMBER - 22051
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Bold Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Thickeners and Stabilizers
Solubilizers
Direct Compression
Lubricants & Glidants
Co-Processed Excipients
Granulation
Parenteral
Rheology Modifiers
Disintegrants & Superdisintegrants
Film Formers & Plasticizers
Emulsifying Agents
Coating Systems & Additives
Topical
Controlled & Modified Release
Taste Masking
Surfactant & Foaming Agents
Chewable & Orodispersible Aids
API Stability Enhancers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
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PharmaCompass offers a list of Fluticasone Furoate 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 Fluticasone Furoate manufacturer or Fluticasone Furoate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Fluticasone Furoate manufacturer or Fluticasone Furoate supplier.
PharmaCompass also assists you with knowing the Fluticasone Furoate API Price utilized in the formulation of products. Fluticasone Furoate API Price is not always fixed or binding as the Fluticasone Furoate Price is obtained through a variety of data sources. The Fluticasone Furoate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A BREO ELLIPTA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BREO ELLIPTA, including repackagers and relabelers. The FDA regulates BREO ELLIPTA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BREO ELLIPTA 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 BREO ELLIPTA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BREO ELLIPTA supplier is an individual or a company that provides BREO ELLIPTA active pharmaceutical ingredient (API) or BREO ELLIPTA finished formulations upon request. The BREO ELLIPTA suppliers may include BREO ELLIPTA API manufacturers, exporters, distributors and traders.
click here to find a list of BREO ELLIPTA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BREO ELLIPTA DMF (Drug Master File) is a document detailing the whole manufacturing process of BREO ELLIPTA active pharmaceutical ingredient (API) in detail. Different forms of BREO ELLIPTA DMFs exist exist since differing nations have different regulations, such as BREO ELLIPTA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BREO ELLIPTA DMF submitted to regulatory agencies in the US is known as a USDMF. BREO ELLIPTA USDMF includes data on BREO ELLIPTA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BREO ELLIPTA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BREO ELLIPTA 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 BREO ELLIPTA Drug Master File in Japan (BREO ELLIPTA JDMF) empowers BREO ELLIPTA 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 BREO ELLIPTA JDMF during the approval evaluation for pharmaceutical products. At the time of BREO ELLIPTA 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 BREO ELLIPTA 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 BREO ELLIPTA Drug Master File in Korea (BREO ELLIPTA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BREO ELLIPTA. The MFDS reviews the BREO ELLIPTA KDMF as part of the drug registration process and uses the information provided in the BREO ELLIPTA KDMF to evaluate the safety and efficacy of the drug.
After submitting a BREO ELLIPTA 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 BREO ELLIPTA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BREO ELLIPTA suppliers with KDMF on PharmaCompass.
A BREO ELLIPTA CEP of the European Pharmacopoeia monograph is often referred to as a BREO ELLIPTA Certificate of Suitability (COS). The purpose of a BREO ELLIPTA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of BREO ELLIPTA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of BREO ELLIPTA to their clients by showing that a BREO ELLIPTA CEP has been issued for it. The manufacturer submits a BREO ELLIPTA CEP (COS) as part of the market authorization procedure, and it takes on the role of a BREO ELLIPTA CEP holder for the record. Additionally, the data presented in the BREO ELLIPTA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the BREO ELLIPTA DMF.
A BREO ELLIPTA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. BREO ELLIPTA 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 BREO ELLIPTA suppliers with CEP (COS) on PharmaCompass.
A BREO ELLIPTA written confirmation (BREO ELLIPTA WC) is an official document issued by a regulatory agency to a BREO ELLIPTA manufacturer, verifying that the manufacturing facility of a BREO ELLIPTA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BREO ELLIPTA APIs or BREO ELLIPTA finished pharmaceutical products to another nation, regulatory agencies frequently require a BREO ELLIPTA WC (written confirmation) as part of the regulatory process.
click here to find a list of BREO ELLIPTA 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 BREO ELLIPTA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BREO ELLIPTA 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 BREO ELLIPTA 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 BREO ELLIPTA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BREO ELLIPTA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BREO ELLIPTA suppliers with NDC on PharmaCompass.
BREO ELLIPTA 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 BREO ELLIPTA 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 BREO ELLIPTA GMP manufacturer or BREO ELLIPTA GMP API supplier for your needs.
A BREO ELLIPTA CoA (Certificate of Analysis) is a formal document that attests to BREO ELLIPTA's compliance with BREO ELLIPTA specifications and serves as a tool for batch-level quality control.
BREO ELLIPTA CoA mostly includes findings from lab analyses of a specific batch. For each BREO ELLIPTA 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.
BREO ELLIPTA may be tested according to a variety of international standards, such as European Pharmacopoeia (BREO ELLIPTA EP), BREO ELLIPTA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BREO ELLIPTA USP).
