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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 : Cerdelga
Dosage Form : HARD CAPSULES
Dosage Strength : 84 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 : Norway
Brand Name : Cerdelga
Dosage Form : Capsule, hard
Dosage Strength : 84 mg
Packaging : Blister
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Application Number :
Regulatory Info :
Registration Country : Norway
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info :
Registration Country : Switzerland
Brand Name : Cerdelga
Dosage Form : Caps
Dosage Strength : 84mg
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Registration Country : Switzerland
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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 : Canada
ELIGLUSTAT (ELIGLUSTAT TARTRATE)
Brand Name : CERDELGA
Dosage Form : CAPSULE
Dosage Strength : 84MG
Packaging : 14/56
Approval Date :
Application Number : 2463261
Regulatory Info :
Registration Country : Canada
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US Patents
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2031-01-31
US Patent Number : 10888547
Drug Substance Claim :
Drug Product Claim :
Application Number : 205494
Patent Use Code : U-3043
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-01-31
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2038-12-13
US Patent Number : 10888544
Drug Substance Claim :
Drug Product Claim :
Application Number : 205494
Patent Use Code : U-3041
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-12-13
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2038-12-13
US Patent Number : 10888544
Drug Substance Claim :
Drug Product Claim :
Application Number : 205494
Patent Use Code : U-3040
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-12-13
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2026-06-26
US Patent Number : 7196205
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 205494
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2026-06-26
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2030-11-24
US Patent Number : 11458119
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 205494
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-11-24
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Patent Expiration Date : 2031-01-31
US Patent Number : 10888547
Drug Substance Claim :
Drug Product Claim :
Application Number : 205494
Patent Use Code : U-3042
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2031-01-31
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
A Eliglustat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eliglustat, including repackagers and relabelers. The FDA regulates Eliglustat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eliglustat 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 Eliglustat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eliglustat supplier is an individual or a company that provides Eliglustat active pharmaceutical ingredient (API) or Eliglustat finished formulations upon request. The Eliglustat suppliers may include Eliglustat API manufacturers, exporters, distributors and traders.
click here to find a list of Eliglustat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eliglustat DMF (Drug Master File) is a document detailing the whole manufacturing process of Eliglustat active pharmaceutical ingredient (API) in detail. Different forms of Eliglustat DMFs exist exist since differing nations have different regulations, such as Eliglustat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eliglustat DMF submitted to regulatory agencies in the US is known as a USDMF. Eliglustat USDMF includes data on Eliglustat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eliglustat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eliglustat 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 Eliglustat Drug Master File in Korea (Eliglustat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eliglustat. The MFDS reviews the Eliglustat KDMF as part of the drug registration process and uses the information provided in the Eliglustat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eliglustat 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 Eliglustat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eliglustat suppliers with KDMF on PharmaCompass.
A Eliglustat written confirmation (Eliglustat WC) is an official document issued by a regulatory agency to a Eliglustat manufacturer, verifying that the manufacturing facility of a Eliglustat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eliglustat APIs or Eliglustat finished pharmaceutical products to another nation, regulatory agencies frequently require a Eliglustat WC (written confirmation) as part of the regulatory process.
click here to find a list of Eliglustat 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 Eliglustat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eliglustat 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 Eliglustat 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 Eliglustat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eliglustat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eliglustat suppliers with NDC on PharmaCompass.
Eliglustat 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 Eliglustat 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 Eliglustat GMP manufacturer or Eliglustat GMP API supplier for your needs.
A Eliglustat CoA (Certificate of Analysis) is a formal document that attests to Eliglustat's compliance with Eliglustat specifications and serves as a tool for batch-level quality control.
Eliglustat CoA mostly includes findings from lab analyses of a specific batch. For each Eliglustat 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.
Eliglustat may be tested according to a variety of international standards, such as European Pharmacopoeia (Eliglustat EP), Eliglustat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eliglustat USP).
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