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PharmaCompass offers a list of Ensifentrine 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 Ensifentrine manufacturer or Ensifentrine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ensifentrine manufacturer or Ensifentrine supplier.
PharmaCompass also assists you with knowing the Ensifentrine API Price utilized in the formulation of products. Ensifentrine API Price is not always fixed or binding as the Ensifentrine Price is obtained through a variety of data sources. The Ensifentrine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A RPL 554 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of RPL 554, including repackagers and relabelers. The FDA regulates RPL 554 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. RPL 554 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 RPL 554 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A RPL 554 supplier is an individual or a company that provides RPL 554 active pharmaceutical ingredient (API) or RPL 554 finished formulations upon request. The RPL 554 suppliers may include RPL 554 API manufacturers, exporters, distributors and traders.
click here to find a list of RPL 554 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A RPL 554 DMF (Drug Master File) is a document detailing the whole manufacturing process of RPL 554 active pharmaceutical ingredient (API) in detail. Different forms of RPL 554 DMFs exist exist since differing nations have different regulations, such as RPL 554 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A RPL 554 DMF submitted to regulatory agencies in the US is known as a USDMF. RPL 554 USDMF includes data on RPL 554's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The RPL 554 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of RPL 554 suppliers with USDMF 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 RPL 554 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for RPL 554 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 RPL 554 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 RPL 554 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a RPL 554 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of RPL 554 suppliers with NDC on PharmaCompass.
RPL 554 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 RPL 554 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 RPL 554 GMP manufacturer or RPL 554 GMP API supplier for your needs.
A RPL 554 CoA (Certificate of Analysis) is a formal document that attests to RPL 554's compliance with RPL 554 specifications and serves as a tool for batch-level quality control.
RPL 554 CoA mostly includes findings from lab analyses of a specific batch. For each RPL 554 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.
RPL 554 may be tested according to a variety of international standards, such as European Pharmacopoeia (RPL 554 EP), RPL 554 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (RPL 554 USP).
