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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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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API Imports and Exports
Drugs in Development
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SPI Pharma
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Direct Compression
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Taste Masking
Excipient Details : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
Lubricants & Glidants
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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 Acalabrutinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Acalabrutinib, including repackagers and relabelers. The FDA regulates Acalabrutinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Acalabrutinib 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 Acalabrutinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Acalabrutinib supplier is an individual or a company that provides Acalabrutinib active pharmaceutical ingredient (API) or Acalabrutinib finished formulations upon request. The Acalabrutinib suppliers may include Acalabrutinib API manufacturers, exporters, distributors and traders.
click here to find a list of Acalabrutinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Acalabrutinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Acalabrutinib active pharmaceutical ingredient (API) in detail. Different forms of Acalabrutinib DMFs exist exist since differing nations have different regulations, such as Acalabrutinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Acalabrutinib DMF submitted to regulatory agencies in the US is known as a USDMF. Acalabrutinib USDMF includes data on Acalabrutinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Acalabrutinib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Acalabrutinib 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 Acalabrutinib Drug Master File in Korea (Acalabrutinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Acalabrutinib. The MFDS reviews the Acalabrutinib KDMF as part of the drug registration process and uses the information provided in the Acalabrutinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Acalabrutinib 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 Acalabrutinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Acalabrutinib suppliers with KDMF on PharmaCompass.
A Acalabrutinib written confirmation (Acalabrutinib WC) is an official document issued by a regulatory agency to a Acalabrutinib manufacturer, verifying that the manufacturing facility of a Acalabrutinib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Acalabrutinib APIs or Acalabrutinib finished pharmaceutical products to another nation, regulatory agencies frequently require a Acalabrutinib WC (written confirmation) as part of the regulatory process.
click here to find a list of Acalabrutinib 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 Acalabrutinib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Acalabrutinib 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 Acalabrutinib 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 Acalabrutinib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Acalabrutinib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Acalabrutinib suppliers with NDC on PharmaCompass.
Acalabrutinib 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 Acalabrutinib 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 Acalabrutinib GMP manufacturer or Acalabrutinib GMP API supplier for your needs.
A Acalabrutinib CoA (Certificate of Analysis) is a formal document that attests to Acalabrutinib's compliance with Acalabrutinib specifications and serves as a tool for batch-level quality control.
Acalabrutinib CoA mostly includes findings from lab analyses of a specific batch. For each Acalabrutinib 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.
Acalabrutinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Acalabrutinib EP), Acalabrutinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Acalabrutinib USP).
