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Century has been an API manufacturer for over 40 years & is the partner of choice for multipurpose custom manufacturing projects.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
AMI Lifesciences is Driven by Chemistry. Powered by People.
EU-WC
KDMF
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HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
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USDMF
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Renvela
Dosage Form : PULVER TILL ORAL SUSPENSION
Dosage Strength : 2,4 G
Packaging :
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Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Renvela
Dosage Form : PULVER TILL ORAL SUSPENSION
Dosage Strength : 1,6 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Renvela
Dosage Form : FILMDRAGERAD TABLETT
Dosage Strength : 800 MG
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Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Sevelamer carbonate Zentiva
Dosage Form : FILM COATED PILL
Dosage Strength : 800 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Sweden
Brand Name : Sevelamer carbonate Zentiva
Dosage Form : POWDER FOR ORAL SUSPENSION
Dosage Strength : 2.4 G
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sevelamer Carbonate 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 Sevelamer Carbonate manufacturer or Sevelamer Carbonate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sevelamer Carbonate manufacturer or Sevelamer Carbonate supplier.
PharmaCompass also assists you with knowing the Sevelamer Carbonate API Price utilized in the formulation of products. Sevelamer Carbonate API Price is not always fixed or binding as the Sevelamer Carbonate Price is obtained through a variety of data sources. The Sevelamer Carbonate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Sevelamer Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sevelamer Carbonate, including repackagers and relabelers. The FDA regulates Sevelamer Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sevelamer Carbonate 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 Sevelamer Carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sevelamer Carbonate supplier is an individual or a company that provides Sevelamer Carbonate active pharmaceutical ingredient (API) or Sevelamer Carbonate finished formulations upon request. The Sevelamer Carbonate suppliers may include Sevelamer Carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Sevelamer Carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sevelamer Carbonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sevelamer Carbonate active pharmaceutical ingredient (API) in detail. Different forms of Sevelamer Carbonate DMFs exist exist since differing nations have different regulations, such as Sevelamer Carbonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sevelamer Carbonate DMF submitted to regulatory agencies in the US is known as a USDMF. Sevelamer Carbonate USDMF includes data on Sevelamer Carbonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sevelamer Carbonate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sevelamer Carbonate 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 Sevelamer Carbonate Drug Master File in Korea (Sevelamer Carbonate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Sevelamer Carbonate. The MFDS reviews the Sevelamer Carbonate KDMF as part of the drug registration process and uses the information provided in the Sevelamer Carbonate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Sevelamer Carbonate 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 Sevelamer Carbonate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Sevelamer Carbonate suppliers with KDMF on PharmaCompass.
A Sevelamer Carbonate written confirmation (Sevelamer Carbonate WC) is an official document issued by a regulatory agency to a Sevelamer Carbonate manufacturer, verifying that the manufacturing facility of a Sevelamer Carbonate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Sevelamer Carbonate APIs or Sevelamer Carbonate finished pharmaceutical products to another nation, regulatory agencies frequently require a Sevelamer Carbonate WC (written confirmation) as part of the regulatory process.
click here to find a list of Sevelamer Carbonate 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 Sevelamer Carbonate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sevelamer Carbonate 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 Sevelamer Carbonate 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 Sevelamer Carbonate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sevelamer Carbonate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sevelamer Carbonate suppliers with NDC on PharmaCompass.
Sevelamer Carbonate 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 Sevelamer Carbonate 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 Sevelamer Carbonate GMP manufacturer or Sevelamer Carbonate GMP API supplier for your needs.
A Sevelamer Carbonate CoA (Certificate of Analysis) is a formal document that attests to Sevelamer Carbonate's compliance with Sevelamer Carbonate specifications and serves as a tool for batch-level quality control.
Sevelamer Carbonate CoA mostly includes findings from lab analyses of a specific batch. For each Sevelamer Carbonate 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.
Sevelamer Carbonate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sevelamer Carbonate EP), Sevelamer Carbonate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sevelamer Carbonate USP).
