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API SUPPLIERS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
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USDMF
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
GDUFA
DMF Review : Complete
Rev. Date : 2022-04-18
Pay. Date : 2022-03-23
DMF Number : 36413
Submission : 2022-03-16
Status :
Type : II
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PharmaCompass offers a list of Sodium Zirconium Cyclosilicate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sodium Zirconium Cyclosilicate manufacturer or Sodium Zirconium Cyclosilicate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sodium Zirconium Cyclosilicate manufacturer or Sodium Zirconium Cyclosilicate supplier.
A Sodium Zirconium Cyclosilicate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Zirconium Cyclosilicate, including repackagers and relabelers. The FDA regulates Sodium Zirconium Cyclosilicate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Zirconium Cyclosilicate 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 Sodium Zirconium Cyclosilicate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Sodium Zirconium Cyclosilicate supplier is an individual or a company that provides Sodium Zirconium Cyclosilicate active pharmaceutical ingredient (API) or Sodium Zirconium Cyclosilicate finished formulations upon request. The Sodium Zirconium Cyclosilicate suppliers may include Sodium Zirconium Cyclosilicate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Zirconium Cyclosilicate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Sodium Zirconium Cyclosilicate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Zirconium Cyclosilicate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Zirconium Cyclosilicate DMFs exist exist since differing nations have different regulations, such as Sodium Zirconium Cyclosilicate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Zirconium Cyclosilicate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Zirconium Cyclosilicate USDMF includes data on Sodium Zirconium Cyclosilicate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Zirconium Cyclosilicate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Zirconium Cyclosilicate 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 Sodium Zirconium Cyclosilicate Drug Master File in Korea (Sodium Zirconium Cyclosilicate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sodium Zirconium Cyclosilicate. The MFDS reviews the Sodium Zirconium Cyclosilicate KDMF as part of the drug registration process and uses the information provided in the Sodium Zirconium Cyclosilicate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sodium Zirconium Cyclosilicate 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 Sodium Zirconium Cyclosilicate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sodium Zirconium Cyclosilicate suppliers with KDMF on PharmaCompass.
A Sodium Zirconium Cyclosilicate written confirmation (Sodium Zirconium Cyclosilicate WC) is an official document issued by a regulatory agency to a Sodium Zirconium Cyclosilicate manufacturer, verifying that the manufacturing facility of a Sodium Zirconium Cyclosilicate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sodium Zirconium Cyclosilicate APIs or Sodium Zirconium Cyclosilicate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sodium Zirconium Cyclosilicate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sodium Zirconium Cyclosilicate 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 Sodium Zirconium Cyclosilicate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Zirconium Cyclosilicate 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 Sodium Zirconium Cyclosilicate 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 Sodium Zirconium Cyclosilicate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Zirconium Cyclosilicate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Zirconium Cyclosilicate suppliers with NDC on PharmaCompass.
Sodium Zirconium Cyclosilicate 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 Sodium Zirconium Cyclosilicate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sodium Zirconium Cyclosilicate GMP manufacturer or Sodium Zirconium Cyclosilicate GMP API supplier for your needs.
A Sodium Zirconium Cyclosilicate CoA (Certificate of Analysis) is a formal document that attests to Sodium Zirconium Cyclosilicate's compliance with Sodium Zirconium Cyclosilicate specifications and serves as a tool for batch-level quality control.
Sodium Zirconium Cyclosilicate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Zirconium Cyclosilicate 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.
Sodium Zirconium Cyclosilicate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Zirconium Cyclosilicate EP), Sodium Zirconium Cyclosilicate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Zirconium Cyclosilicate USP).
