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PharmaCompass offers a list of Sodium Alginate 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 Alginate manufacturer or Sodium Alginate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Alginate manufacturer or Sodium Alginate supplier.
PharmaCompass also assists you with knowing the Sodium Alginate API Price utilized in the formulation of products. Sodium Alginate API Price is not always fixed or binding as the Sodium Alginate Price is obtained through a variety of data sources. The Sodium Alginate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A calcium alginate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of calcium alginate, including repackagers and relabelers. The FDA regulates calcium alginate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. calcium alginate 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 calcium alginate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A calcium alginate supplier is an individual or a company that provides calcium alginate active pharmaceutical ingredient (API) or calcium alginate finished formulations upon request. The calcium alginate suppliers may include calcium alginate API manufacturers, exporters, distributors and traders.
click here to find a list of calcium alginate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A calcium alginate DMF (Drug Master File) is a document detailing the whole manufacturing process of calcium alginate active pharmaceutical ingredient (API) in detail. Different forms of calcium alginate DMFs exist exist since differing nations have different regulations, such as calcium alginate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A calcium alginate DMF submitted to regulatory agencies in the US is known as a USDMF. calcium alginate USDMF includes data on calcium alginate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The calcium alginate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of calcium alginate suppliers with USDMF 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 calcium alginate Drug Master File in Korea (calcium alginate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of calcium alginate. The MFDS reviews the calcium alginate KDMF as part of the drug registration process and uses the information provided in the calcium alginate KDMF to evaluate the safety and efficacy of the drug.
After submitting a calcium alginate 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 calcium alginate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of calcium alginate suppliers with KDMF on PharmaCompass.
A calcium alginate written confirmation (calcium alginate WC) is an official document issued by a regulatory agency to a calcium alginate manufacturer, verifying that the manufacturing facility of a calcium alginate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting calcium alginate APIs or calcium alginate finished pharmaceutical products to another nation, regulatory agencies frequently require a calcium alginate WC (written confirmation) as part of the regulatory process.
click here to find a list of calcium alginate suppliers with Written Confirmation (WC) on PharmaCompass.
calcium alginate 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 calcium alginate 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 calcium alginate GMP manufacturer or calcium alginate GMP API supplier for your needs.
A calcium alginate CoA (Certificate of Analysis) is a formal document that attests to calcium alginate's compliance with calcium alginate specifications and serves as a tool for batch-level quality control.
calcium alginate CoA mostly includes findings from lab analyses of a specific batch. For each calcium alginate 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.
calcium alginate may be tested according to a variety of international standards, such as European Pharmacopoeia (calcium alginate EP), calcium alginate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (calcium alginate USP).
