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CEP/COS
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JDMF
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EU WC
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KDMF
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FDF Dossiers
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FDA Orange Book
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Europe
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API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Hydroxy Echinocandin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydroxy Echinocandin, including repackagers and relabelers. The FDA regulates Hydroxy Echinocandin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydroxy Echinocandin 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 Hydroxy Echinocandin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydroxy Echinocandin supplier is an individual or a company that provides Hydroxy Echinocandin active pharmaceutical ingredient (API) or Hydroxy Echinocandin finished formulations upon request. The Hydroxy Echinocandin suppliers may include Hydroxy Echinocandin API manufacturers, exporters, distributors and traders.
click here to find a list of Hydroxy Echinocandin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Hydroxy Echinocandin DMF (Drug Master File) is a document detailing the whole manufacturing process of Hydroxy Echinocandin active pharmaceutical ingredient (API) in detail. Different forms of Hydroxy Echinocandin DMFs exist exist since differing nations have different regulations, such as Hydroxy Echinocandin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Hydroxy Echinocandin DMF submitted to regulatory agencies in the US is known as a USDMF. Hydroxy Echinocandin USDMF includes data on Hydroxy Echinocandin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Hydroxy Echinocandin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Hydroxy Echinocandin 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 Hydroxy Echinocandin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Hydroxy Echinocandin 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 Hydroxy Echinocandin 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 Hydroxy Echinocandin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Hydroxy Echinocandin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Hydroxy Echinocandin suppliers with NDC on PharmaCompass.
Hydroxy Echinocandin 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 Hydroxy Echinocandin 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 Hydroxy Echinocandin GMP manufacturer or Hydroxy Echinocandin GMP API supplier for your needs.
A Hydroxy Echinocandin CoA (Certificate of Analysis) is a formal document that attests to Hydroxy Echinocandin's compliance with Hydroxy Echinocandin specifications and serves as a tool for batch-level quality control.
Hydroxy Echinocandin CoA mostly includes findings from lab analyses of a specific batch. For each Hydroxy Echinocandin 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.
Hydroxy Echinocandin may be tested according to a variety of international standards, such as European Pharmacopoeia (Hydroxy Echinocandin EP), Hydroxy Echinocandin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Hydroxy Echinocandin USP).
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