Synopsis
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CEP/COS
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JDMF
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VMF
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EDQM
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USP
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JP
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Others
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Canada
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Suanfarma, at the Core of a Better Life.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC 
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
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USDMF
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36174
Submission : 2021-11-30
Status :
Type : II
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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Regulatory Info :
Registration Country : Hungary
Brand Name :
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Hungary
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Coating Systems & Additives
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Direct Compression
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Granulation
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Co-Processed Excipients
Chewable & Orodispersible Aids
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Topical
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Parenteral
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ribociclib 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 Ribociclib manufacturer or Ribociclib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ribociclib manufacturer or Ribociclib supplier.
PharmaCompass also assists you with knowing the Ribociclib API Price utilized in the formulation of products. Ribociclib API Price is not always fixed or binding as the Ribociclib Price is obtained through a variety of data sources. The Ribociclib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ribociclib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ribociclib, including repackagers and relabelers. The FDA regulates Ribociclib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ribociclib 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 Ribociclib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ribociclib supplier is an individual or a company that provides Ribociclib active pharmaceutical ingredient (API) or Ribociclib finished formulations upon request. The Ribociclib suppliers may include Ribociclib API manufacturers, exporters, distributors and traders.
click here to find a list of Ribociclib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ribociclib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ribociclib active pharmaceutical ingredient (API) in detail. Different forms of Ribociclib DMFs exist exist since differing nations have different regulations, such as Ribociclib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ribociclib DMF submitted to regulatory agencies in the US is known as a USDMF. Ribociclib USDMF includes data on Ribociclib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ribociclib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ribociclib 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 Ribociclib Drug Master File in Korea (Ribociclib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ribociclib. The MFDS reviews the Ribociclib KDMF as part of the drug registration process and uses the information provided in the Ribociclib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ribociclib 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 Ribociclib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ribociclib suppliers with KDMF on PharmaCompass.
A Ribociclib written confirmation (Ribociclib WC) is an official document issued by a regulatory agency to a Ribociclib manufacturer, verifying that the manufacturing facility of a Ribociclib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ribociclib APIs or Ribociclib finished pharmaceutical products to another nation, regulatory agencies frequently require a Ribociclib WC (written confirmation) as part of the regulatory process.
click here to find a list of Ribociclib 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 Ribociclib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ribociclib 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 Ribociclib 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 Ribociclib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ribociclib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ribociclib suppliers with NDC on PharmaCompass.
Ribociclib 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 Ribociclib 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 Ribociclib GMP manufacturer or Ribociclib GMP API supplier for your needs.
A Ribociclib CoA (Certificate of Analysis) is a formal document that attests to Ribociclib's compliance with Ribociclib specifications and serves as a tool for batch-level quality control.
Ribociclib CoA mostly includes findings from lab analyses of a specific batch. For each Ribociclib 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.
Ribociclib may be tested according to a variety of international standards, such as European Pharmacopoeia (Ribociclib EP), Ribociclib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ribociclib USP).
