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API SUPPLIERS
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
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KDMF
Topscience Biotech specializes in R&D, production, sales of Sodium Hyaluronate, focusing on Cosmetics, Medical, Pharmaceutical Grade HA
Basic Nutrition, your expert for sourcing from China, India and Europe.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
KDMF
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
KDMF
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
KDMF
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
KDMF
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
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USDMF
Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37583
Submission : 2022-10-28
Status :
Type : IV
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Bioiberica is a global life science company committed to improving the health & wellbeing of people, animals & plants.
About the Company : Bioiberica is a global Life Science company with more than 45 years' experience in the production and development of molecules of high biological and therapeutic value for the phar...
Topscience Biotech specializes in R&D, production, sales of Sodium Hyaluronate, focusing on Cosmetics, Medical, Pharmaceutical Grade HA
About the Company : Established in 2005, Topscience located in Lanshan, Rizhao of PRC and covers an area of 100,000m². Products include Sodium Hyaluronate, Chondroitin Sulfate, Alpha-Arbutin, L-Ascor...
Basic Nutrition, your expert for sourcing from China, India and Europe.
About the Company : As an ISO9001, ISO22000 certificated supplier, Basic Nutrition supply high-quality ingredients for nutraceuticals. We can offer a range of products from small to large quantites: h...
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Chondroitin Sulfate Sodium 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 Sodium manufacturer or Chondroitin Sulfate Sodium supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Chondroitin Sulfate Sodium manufacturer or Chondroitin Sulfate Sodium supplier.
PharmaCompass also assists you with knowing the Chondroitin Sulfate Sodium API Price utilized in the formulation of products. Chondroitin Sulfate Sodium API Price is not always fixed or binding as the Chondroitin Sulfate Sodium Price is obtained through a variety of data sources. The Chondroitin Sulfate Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Chondroitin Sulphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Chondroitin Sulphate, including repackagers and relabelers. The FDA regulates Chondroitin Sulphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Chondroitin Sulphate 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 Sulphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Chondroitin Sulphate supplier is an individual or a company that provides Chondroitin Sulphate active pharmaceutical ingredient (API) or Chondroitin Sulphate finished formulations upon request. The Chondroitin Sulphate suppliers may include Chondroitin Sulphate API manufacturers, exporters, distributors and traders.
click here to find a list of Chondroitin Sulphate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Chondroitin Sulphate DMF (Drug Master File) is a document detailing the whole manufacturing process of Chondroitin Sulphate active pharmaceutical ingredient (API) in detail. Different forms of Chondroitin Sulphate DMFs exist exist since differing nations have different regulations, such as Chondroitin Sulphate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Chondroitin Sulphate DMF submitted to regulatory agencies in the US is known as a USDMF. Chondroitin Sulphate USDMF includes data on Chondroitin Sulphate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Chondroitin Sulphate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Chondroitin Sulphate 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 Sulphate Drug Master File in Japan (Chondroitin Sulphate JDMF) empowers Chondroitin Sulphate 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 Sulphate JDMF during the approval evaluation for pharmaceutical products. At the time of Chondroitin Sulphate 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 Sulphate 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 Sulphate Drug Master File in Korea (Chondroitin Sulphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Chondroitin Sulphate. The MFDS reviews the Chondroitin Sulphate KDMF as part of the drug registration process and uses the information provided in the Chondroitin Sulphate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Chondroitin Sulphate 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 Sulphate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Chondroitin Sulphate suppliers with KDMF on PharmaCompass.
A Chondroitin Sulphate CEP of the European Pharmacopoeia monograph is often referred to as a Chondroitin Sulphate Certificate of Suitability (COS). The purpose of a Chondroitin Sulphate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Chondroitin Sulphate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Chondroitin Sulphate to their clients by showing that a Chondroitin Sulphate CEP has been issued for it. The manufacturer submits a Chondroitin Sulphate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Chondroitin Sulphate CEP holder for the record. Additionally, the data presented in the Chondroitin Sulphate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Chondroitin Sulphate DMF.
A Chondroitin Sulphate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Chondroitin Sulphate 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 Sulphate suppliers with CEP (COS) on PharmaCompass.
A Chondroitin Sulphate written confirmation (Chondroitin Sulphate WC) is an official document issued by a regulatory agency to a Chondroitin Sulphate manufacturer, verifying that the manufacturing facility of a Chondroitin Sulphate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Chondroitin Sulphate APIs or Chondroitin Sulphate finished pharmaceutical products to another nation, regulatory agencies frequently require a Chondroitin Sulphate WC (written confirmation) as part of the regulatory process.
click here to find a list of Chondroitin Sulphate suppliers with Written Confirmation (WC) on PharmaCompass.
Chondroitin Sulphate 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 Sulphate 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 Sulphate GMP manufacturer or Chondroitin Sulphate GMP API supplier for your needs.
A Chondroitin Sulphate CoA (Certificate of Analysis) is a formal document that attests to Chondroitin Sulphate's compliance with Chondroitin Sulphate specifications and serves as a tool for batch-level quality control.
Chondroitin Sulphate CoA mostly includes findings from lab analyses of a specific batch. For each Chondroitin Sulphate 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 Sulphate may be tested according to a variety of international standards, such as European Pharmacopoeia (Chondroitin Sulphate EP), Chondroitin Sulphate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Chondroitin Sulphate USP).
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