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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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NDC API
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VMF
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FDF
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FDA Orange Book
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Europe
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Canada
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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EDQM
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USP
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JP
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US Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
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US Medicaid
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API SUPPLIERS
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USDMF
Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37812
Submission : 2022-12-30
Status :
Type : II
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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.
About the Company : Bloomage Biotechnology Corporation Limited, formerly Bloomage Freda Biopharm, was established by Bloomage International Investment Group. It is a global leader in bioactive materia...
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API Imports and Exports
Drugs in Development
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ectoine 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 Ectoine manufacturer or Ectoine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ectoine manufacturer or Ectoine supplier.
PharmaCompass also assists you with knowing the Ectoine API Price utilized in the formulation of products. Ectoine API Price is not always fixed or binding as the Ectoine Price is obtained through a variety of data sources. The Ectoine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ectoine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ectoine, including repackagers and relabelers. The FDA regulates Ectoine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ectoine 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 Ectoine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ectoine supplier is an individual or a company that provides Ectoine active pharmaceutical ingredient (API) or Ectoine finished formulations upon request. The Ectoine suppliers may include Ectoine API manufacturers, exporters, distributors and traders.
click here to find a list of Ectoine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ectoine DMF (Drug Master File) is a document detailing the whole manufacturing process of Ectoine active pharmaceutical ingredient (API) in detail. Different forms of Ectoine DMFs exist exist since differing nations have different regulations, such as Ectoine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ectoine DMF submitted to regulatory agencies in the US is known as a USDMF. Ectoine USDMF includes data on Ectoine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ectoine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ectoine suppliers with USDMF on PharmaCompass.
Ectoine 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 Ectoine 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 Ectoine GMP manufacturer or Ectoine GMP API supplier for your needs.
A Ectoine CoA (Certificate of Analysis) is a formal document that attests to Ectoine's compliance with Ectoine specifications and serves as a tool for batch-level quality control.
Ectoine CoA mostly includes findings from lab analyses of a specific batch. For each Ectoine 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.
Ectoine may be tested according to a variety of international standards, such as European Pharmacopoeia (Ectoine EP), Ectoine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ectoine USP).
