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ABOUT THIS PAGE
17
PharmaCompass offers a list of Umeclidinium Bromide 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 Umeclidinium Bromide manufacturer or Umeclidinium Bromide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Umeclidinium Bromide manufacturer or Umeclidinium Bromide supplier.
PharmaCompass also assists you with knowing the Umeclidinium Bromide API Price utilized in the formulation of products. Umeclidinium Bromide API Price is not always fixed or binding as the Umeclidinium Bromide Price is obtained through a variety of data sources. The Umeclidinium Bromide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A ANORO ELLIPTA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ANORO ELLIPTA, including repackagers and relabelers. The FDA regulates ANORO ELLIPTA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ANORO 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 ANORO ELLIPTA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ANORO ELLIPTA supplier is an individual or a company that provides ANORO ELLIPTA active pharmaceutical ingredient (API) or ANORO ELLIPTA finished formulations upon request. The ANORO ELLIPTA suppliers may include ANORO ELLIPTA API manufacturers, exporters, distributors and traders.
click here to find a list of ANORO ELLIPTA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ANORO ELLIPTA DMF (Drug Master File) is a document detailing the whole manufacturing process of ANORO ELLIPTA active pharmaceutical ingredient (API) in detail. Different forms of ANORO ELLIPTA DMFs exist exist since differing nations have different regulations, such as ANORO ELLIPTA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ANORO ELLIPTA DMF submitted to regulatory agencies in the US is known as a USDMF. ANORO ELLIPTA USDMF includes data on ANORO ELLIPTA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ANORO ELLIPTA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ANORO ELLIPTA 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 ANORO ELLIPTA Drug Master File in Korea (ANORO ELLIPTA KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ANORO ELLIPTA. The MFDS reviews the ANORO ELLIPTA KDMF as part of the drug registration process and uses the information provided in the ANORO ELLIPTA KDMF to evaluate the safety and efficacy of the drug.
After submitting a ANORO 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 ANORO ELLIPTA API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ANORO ELLIPTA suppliers with KDMF 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 ANORO ELLIPTA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ANORO 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 ANORO 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 ANORO ELLIPTA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ANORO ELLIPTA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ANORO ELLIPTA suppliers with NDC on PharmaCompass.
ANORO 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 ANORO 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 ANORO ELLIPTA GMP manufacturer or ANORO ELLIPTA GMP API supplier for your needs.
A ANORO ELLIPTA CoA (Certificate of Analysis) is a formal document that attests to ANORO ELLIPTA's compliance with ANORO ELLIPTA specifications and serves as a tool for batch-level quality control.
ANORO ELLIPTA CoA mostly includes findings from lab analyses of a specific batch. For each ANORO 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.
ANORO ELLIPTA may be tested according to a variety of international standards, such as European Pharmacopoeia (ANORO ELLIPTA EP), ANORO ELLIPTA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ANORO ELLIPTA USP).
