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