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Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
Chondroitin Sulfate Sodium, Terrestrial Origin, ...
Certificate Number : CEP 2023-243 - Rev 02
Status : Valid
Issue Date : 2024-12-18
Type : Chemical and TSE
Substance Number : 2064
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
Chondroitin Sulfate Sodium, Terrestrial Porcine ...
Certificate Number : CEP 2024-106 - Rev 00
Status : Valid
Issue Date : 2024-05-14
Type : Chemical
Substance Number : 2064
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
Chondroitin Sulfate Sodium, Process A And B
Certificate Number : R1-CEP 2001-063 - Rev 06
Status : Valid
Issue Date : 2022-10-26
Type : TSE
Substance Number : 2064
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
Chondroitin Sulfate Sodium, Terrestrial Origin
Certificate Number : R1-CEP 2006-209 - Rev 04
Status : Valid
Issue Date : 2021-11-10
Type : Chemical and TSE
Substance Number : 2064
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
Chondroitin Sulfate Sodium, European Origin
Certificate Number : R1-CEP 2007-197 - Rev 02
Status : Valid
Issue Date : 2019-03-27
Type : TSE
Substance Number : 2064
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ABOUT THIS PAGE
A Chondroitin Sulfate Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chondroitin Sulfate Sodium, including repackagers and relabelers. The FDA regulates Chondroitin Sulfate Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chondroitin Sulfate Sodium 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 Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chondroitin Sulfate Sodium supplier is an individual or a company that provides Chondroitin Sulfate Sodium active pharmaceutical ingredient (API) or Chondroitin Sulfate Sodium finished formulations upon request. The Chondroitin Sulfate Sodium suppliers may include Chondroitin Sulfate Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Chondroitin Sulfate Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chondroitin Sulfate Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Chondroitin Sulfate Sodium active pharmaceutical ingredient (API) in detail. Different forms of Chondroitin Sulfate Sodium DMFs exist exist since differing nations have different regulations, such as Chondroitin Sulfate Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chondroitin Sulfate Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Chondroitin Sulfate Sodium USDMF includes data on Chondroitin Sulfate Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chondroitin Sulfate Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chondroitin Sulfate Sodium 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 Sodium Drug Master File in Japan (Chondroitin Sulfate Sodium JDMF) empowers Chondroitin Sulfate Sodium 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 Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Chondroitin Sulfate Sodium 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 Sodium 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 Sodium Drug Master File in Korea (Chondroitin Sulfate Sodium KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chondroitin Sulfate Sodium. The MFDS reviews the Chondroitin Sulfate Sodium KDMF as part of the drug registration process and uses the information provided in the Chondroitin Sulfate Sodium KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chondroitin Sulfate Sodium 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 Sodium API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Chondroitin Sulfate Sodium suppliers with KDMF on PharmaCompass.
A Chondroitin Sulfate Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Chondroitin Sulfate Sodium Certificate of Suitability (COS). The purpose of a Chondroitin Sulfate Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chondroitin Sulfate Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chondroitin Sulfate Sodium to their clients by showing that a Chondroitin Sulfate Sodium CEP has been issued for it. The manufacturer submits a Chondroitin Sulfate Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chondroitin Sulfate Sodium CEP holder for the record. Additionally, the data presented in the Chondroitin Sulfate Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chondroitin Sulfate Sodium DMF.
A Chondroitin Sulfate Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chondroitin Sulfate Sodium 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 Sodium suppliers with CEP (COS) on PharmaCompass.
A Chondroitin Sulfate Sodium written confirmation (Chondroitin Sulfate Sodium WC) is an official document issued by a regulatory agency to a Chondroitin Sulfate Sodium manufacturer, verifying that the manufacturing facility of a Chondroitin Sulfate Sodium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chondroitin Sulfate Sodium APIs or Chondroitin Sulfate Sodium finished pharmaceutical products to another nation, regulatory agencies frequently require a Chondroitin Sulfate Sodium WC (written confirmation) as part of the regulatory process.
click here to find a list of Chondroitin Sulfate Sodium 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 Chondroitin Sulfate Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Chondroitin Sulfate Sodium 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 Chondroitin Sulfate Sodium 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 Chondroitin Sulfate Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Chondroitin Sulfate Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Chondroitin Sulfate Sodium suppliers with NDC on PharmaCompass.
Chondroitin Sulfate Sodium 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 Sodium 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 Sodium GMP manufacturer or Chondroitin Sulfate Sodium GMP API supplier for your needs.
A Chondroitin Sulfate Sodium CoA (Certificate of Analysis) is a formal document that attests to Chondroitin Sulfate Sodium's compliance with Chondroitin Sulfate Sodium specifications and serves as a tool for batch-level quality control.
Chondroitin Sulfate Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Chondroitin Sulfate Sodium 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 Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Chondroitin Sulfate Sodium EP), Chondroitin Sulfate Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chondroitin Sulfate Sodium USP).
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