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
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
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USDMF
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35796
Submission : 2021-04-20
Status :
Type : II
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
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SPI Pharma
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ABOUT THIS PAGE
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PharmaCompass offers a list of Acalabrutinib 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 Acalabrutinib manufacturer or Acalabrutinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Acalabrutinib manufacturer or Acalabrutinib supplier.
PharmaCompass also assists you with knowing the Acalabrutinib API Price utilized in the formulation of products. Acalabrutinib API Price is not always fixed or binding as the Acalabrutinib Price is obtained through a variety of data sources. The Acalabrutinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Calquence manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calquence, including repackagers and relabelers. The FDA regulates Calquence manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calquence 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 Calquence manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calquence supplier is an individual or a company that provides Calquence active pharmaceutical ingredient (API) or Calquence finished formulations upon request. The Calquence suppliers may include Calquence API manufacturers, exporters, distributors and traders.
click here to find a list of Calquence suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calquence DMF (Drug Master File) is a document detailing the whole manufacturing process of Calquence active pharmaceutical ingredient (API) in detail. Different forms of Calquence DMFs exist exist since differing nations have different regulations, such as Calquence USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Calquence DMF submitted to regulatory agencies in the US is known as a USDMF. Calquence USDMF includes data on Calquence's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Calquence USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Calquence 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 Calquence Drug Master File in Korea (Calquence KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Calquence. The MFDS reviews the Calquence KDMF as part of the drug registration process and uses the information provided in the Calquence KDMF to evaluate the safety and efficacy of the drug.
After submitting a Calquence 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 Calquence API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Calquence suppliers with KDMF on PharmaCompass.
A Calquence written confirmation (Calquence WC) is an official document issued by a regulatory agency to a Calquence manufacturer, verifying that the manufacturing facility of a Calquence active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Calquence APIs or Calquence finished pharmaceutical products to another nation, regulatory agencies frequently require a Calquence WC (written confirmation) as part of the regulatory process.
click here to find a list of Calquence 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 Calquence as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Calquence 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 Calquence 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 Calquence and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Calquence NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Calquence suppliers with NDC on PharmaCompass.
Calquence 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 Calquence 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 Calquence GMP manufacturer or Calquence GMP API supplier for your needs.
A Calquence CoA (Certificate of Analysis) is a formal document that attests to Calquence's compliance with Calquence specifications and serves as a tool for batch-level quality control.
Calquence CoA mostly includes findings from lab analyses of a specific batch. For each Calquence 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.
Calquence may be tested according to a variety of international standards, such as European Pharmacopoeia (Calquence EP), Calquence JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Calquence USP).
