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