API Suppliers
US DMFs Filed
CEP/COS Certifications
JDMFs Filed
Other Certificates
Other Suppliers
0
USA (Orange Book)
0
Europe
Canada
0
Australia
0
South Africa
Uploaded Dossiers
U.S. Medicaid
0
Annual Reports
0
0
26
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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Chondroitin Sulfate manufacturer or Chondroitin Sulfate supplier.
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 Calcium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chondroitin Sulfate Calcium, including repackagers and relabelers. The FDA regulates Chondroitin Sulfate Calcium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chondroitin Sulfate Calcium 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 Chondroitin Sulfate Calcium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chondroitin Sulfate Calcium supplier is an individual or a company that provides Chondroitin Sulfate Calcium active pharmaceutical ingredient (API) or Chondroitin Sulfate Calcium finished formulations upon request. The Chondroitin Sulfate Calcium suppliers may include Chondroitin Sulfate Calcium API manufacturers, exporters, distributors and traders.
click here to find a list of Chondroitin Sulfate Calcium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chondroitin Sulfate Calcium DMF (Drug Master File) is a document detailing the whole manufacturing process of Chondroitin Sulfate Calcium active pharmaceutical ingredient (API) in detail. Different forms of Chondroitin Sulfate Calcium DMFs exist exist since differing nations have different regulations, such as Chondroitin Sulfate Calcium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chondroitin Sulfate Calcium DMF submitted to regulatory agencies in the US is known as a USDMF. Chondroitin Sulfate Calcium USDMF includes data on Chondroitin Sulfate Calcium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chondroitin Sulfate Calcium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chondroitin Sulfate Calcium 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 Chondroitin Sulfate Calcium Drug Master File in Japan (Chondroitin Sulfate Calcium JDMF) empowers Chondroitin Sulfate Calcium 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 Calcium JDMF during the approval evaluation for pharmaceutical products. At the time of Chondroitin Sulfate Calcium 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 Chondroitin Sulfate Calcium 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 Chondroitin Sulfate Calcium Drug Master File in Korea (Chondroitin Sulfate Calcium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chondroitin Sulfate Calcium. The MFDS reviews the Chondroitin Sulfate Calcium KDMF as part of the drug registration process and uses the information provided in the Chondroitin Sulfate Calcium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chondroitin Sulfate Calcium 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 Calcium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Chondroitin Sulfate Calcium suppliers with KDMF on PharmaCompass.
A Chondroitin Sulfate Calcium CEP of the European Pharmacopoeia monograph is often referred to as a Chondroitin Sulfate Calcium Certificate of Suitability (COS). The purpose of a Chondroitin Sulfate Calcium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chondroitin Sulfate Calcium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chondroitin Sulfate Calcium to their clients by showing that a Chondroitin Sulfate Calcium CEP has been issued for it. The manufacturer submits a Chondroitin Sulfate Calcium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chondroitin Sulfate Calcium CEP holder for the record. Additionally, the data presented in the Chondroitin Sulfate Calcium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chondroitin Sulfate Calcium DMF.
A Chondroitin Sulfate Calcium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chondroitin Sulfate Calcium 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 Chondroitin Sulfate Calcium suppliers with CEP (COS) on PharmaCompass.
A Chondroitin Sulfate Calcium written confirmation (Chondroitin Sulfate Calcium WC) is an official document issued by a regulatory agency to a Chondroitin Sulfate Calcium manufacturer, verifying that the manufacturing facility of a Chondroitin Sulfate Calcium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chondroitin Sulfate Calcium APIs or Chondroitin Sulfate Calcium finished pharmaceutical products to another nation, regulatory agencies frequently require a Chondroitin Sulfate Calcium WC (written confirmation) as part of the regulatory process.
click here to find a list of Chondroitin Sulfate Calcium suppliers with Written Confirmation (WC) on PharmaCompass.
Chondroitin Sulfate Calcium 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 Calcium 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 Calcium GMP manufacturer or Chondroitin Sulfate Calcium GMP API supplier for your needs.
A Chondroitin Sulfate Calcium CoA (Certificate of Analysis) is a formal document that attests to Chondroitin Sulfate Calcium's compliance with Chondroitin Sulfate Calcium specifications and serves as a tool for batch-level quality control.
Chondroitin Sulfate Calcium CoA mostly includes findings from lab analyses of a specific batch. For each Chondroitin Sulfate Calcium 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 Calcium may be tested according to a variety of international standards, such as European Pharmacopoeia (Chondroitin Sulfate Calcium EP), Chondroitin Sulfate Calcium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chondroitin Sulfate Calcium USP).