US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Chondroitin Sulfate 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 Chondroitin Sulfate manufacturer or Chondroitin Sulfate supplier for your needs.
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PharmaCompass also assists you with knowing the Chondroitin Sulfate API Price utilized in the formulation of products. Chondroitin Sulfate API Price is not always fixed or binding as the Chondroitin Sulfate Price is obtained through a variety of data sources. The Chondroitin Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Chondroitin Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chondroitin Sulfate, including repackagers and relabelers. The FDA regulates Chondroitin Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chondroitin Sulfate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Chondroitin Sulfate supplier is an individual or a company that provides Chondroitin Sulfate active pharmaceutical ingredient (API) or Chondroitin Sulfate finished formulations upon request. The Chondroitin Sulfate suppliers may include Chondroitin Sulfate API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Chondroitin Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chondroitin Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Chondroitin Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Chondroitin Sulfate DMFs exist exist since differing nations have different regulations, such as Chondroitin Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chondroitin Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Chondroitin Sulfate USDMF includes data on Chondroitin Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chondroitin Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Chondroitin Sulfate Drug Master File in Japan (Chondroitin Sulfate JDMF) empowers Chondroitin Sulfate 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 Chondroitin Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Chondroitin Sulfate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Chondroitin Sulfate Drug Master File in Korea (Chondroitin Sulfate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chondroitin Sulfate. The MFDS reviews the Chondroitin Sulfate KDMF as part of the drug registration process and uses the information provided in the Chondroitin Sulfate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chondroitin Sulfate 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 Chondroitin Sulfate API can apply through the Korea Drug Master File (KDMF).
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A Chondroitin Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Chondroitin Sulfate Certificate of Suitability (COS). The purpose of a Chondroitin Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chondroitin Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chondroitin Sulfate to their clients by showing that a Chondroitin Sulfate CEP has been issued for it. The manufacturer submits a Chondroitin Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chondroitin Sulfate CEP holder for the record. Additionally, the data presented in the Chondroitin Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chondroitin Sulfate DMF.
A Chondroitin Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chondroitin Sulfate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Chondroitin Sulfate written confirmation (Chondroitin Sulfate WC) is an official document issued by a regulatory agency to a Chondroitin Sulfate manufacturer, verifying that the manufacturing facility of a Chondroitin Sulfate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chondroitin Sulfate APIs or Chondroitin Sulfate finished pharmaceutical products to another nation, regulatory agencies frequently require a Chondroitin Sulfate WC (written confirmation) as part of the regulatory process.
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Chondroitin Sulfate 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 Chondroitin Sulfate 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 Chondroitin Sulfate GMP manufacturer or Chondroitin Sulfate GMP API supplier for your needs.
A Chondroitin Sulfate CoA (Certificate of Analysis) is a formal document that attests to Chondroitin Sulfate's compliance with Chondroitin Sulfate specifications and serves as a tool for batch-level quality control.
Chondroitin Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Chondroitin Sulfate 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.
Chondroitin Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Chondroitin Sulfate EP), Chondroitin Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chondroitin Sulfate USP).