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FDA Orange Book
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API SUPPLIERS
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USDMF
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EUROAPI
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sodium Hyaluronate 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 Sodium Hyaluronate manufacturer or Sodium Hyaluronate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Hyaluronate manufacturer or Sodium Hyaluronate supplier.
PharmaCompass also assists you with knowing the Sodium Hyaluronate API Price utilized in the formulation of products. Sodium Hyaluronate API Price is not always fixed or binding as the Sodium Hyaluronate Price is obtained through a variety of data sources. The Sodium Hyaluronate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Equron manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Equron, including repackagers and relabelers. The FDA regulates Equron manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Equron 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 Equron manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Equron supplier is an individual or a company that provides Equron active pharmaceutical ingredient (API) or Equron finished formulations upon request. The Equron suppliers may include Equron API manufacturers, exporters, distributors and traders.
click here to find a list of Equron suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Equron DMF (Drug Master File) is a document detailing the whole manufacturing process of Equron active pharmaceutical ingredient (API) in detail. Different forms of Equron DMFs exist exist since differing nations have different regulations, such as Equron USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Equron DMF submitted to regulatory agencies in the US is known as a USDMF. Equron USDMF includes data on Equron's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Equron USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Equron 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 Equron Drug Master File in Japan (Equron JDMF) empowers Equron 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 Equron JDMF during the approval evaluation for pharmaceutical products. At the time of Equron 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 Equron 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 Equron Drug Master File in Korea (Equron KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Equron. The MFDS reviews the Equron KDMF as part of the drug registration process and uses the information provided in the Equron KDMF to evaluate the safety and efficacy of the drug.
After submitting a Equron 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 Equron API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Equron suppliers with KDMF on PharmaCompass.
A Equron CEP of the European Pharmacopoeia monograph is often referred to as a Equron Certificate of Suitability (COS). The purpose of a Equron CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Equron EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Equron to their clients by showing that a Equron CEP has been issued for it. The manufacturer submits a Equron CEP (COS) as part of the market authorization procedure, and it takes on the role of a Equron CEP holder for the record. Additionally, the data presented in the Equron CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Equron DMF.
A Equron CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Equron 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 Equron suppliers with CEP (COS) on PharmaCompass.
A Equron written confirmation (Equron WC) is an official document issued by a regulatory agency to a Equron manufacturer, verifying that the manufacturing facility of a Equron active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Equron APIs or Equron finished pharmaceutical products to another nation, regulatory agencies frequently require a Equron WC (written confirmation) as part of the regulatory process.
click here to find a list of Equron 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 Equron as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Equron 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 Equron 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 Equron and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Equron NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Equron suppliers with NDC on PharmaCompass.
Equron 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 Equron 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 Equron GMP manufacturer or Equron GMP API supplier for your needs.
A Equron CoA (Certificate of Analysis) is a formal document that attests to Equron's compliance with Equron specifications and serves as a tool for batch-level quality control.
Equron CoA mostly includes findings from lab analyses of a specific batch. For each Equron 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.
Equron may be tested according to a variety of international standards, such as European Pharmacopoeia (Equron EP), Equron JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Equron USP).
