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CEP/COS
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JDMF
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32347
Submission : 2017-12-21
Status :
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Complete
Rev. Date : 2019-04-16
Pay. Date : 2019-03-22
DMF Number : 33704
Submission : 2019-03-20
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2019-03-18
Pay. Date : 2018-10-01
DMF Number : 33450
Submission : 2019-02-12
Status :
Type : II
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DOSAGE - TABLET;ORAL - 0.25MG
USFDA APPLICATION NUMBER - 205422
DOSAGE - TABLET;ORAL - 0.5MG
USFDA APPLICATION NUMBER - 205422
DOSAGE - TABLET;ORAL - 1MG
USFDA APPLICATION NUMBER - 205422
DOSAGE - TABLET;ORAL - 2MG
USFDA APPLICATION NUMBER - 205422
DOSAGE - TABLET;ORAL - 3MG
USFDA APPLICATION NUMBER - 205422
DOSAGE - TABLET;ORAL - 4MG
USFDA APPLICATION NUMBER - 205422
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REF. STANDARDS & IMPURITIES
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PharmaCompass offers a list of Brexpiprazole 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 Brexpiprazole manufacturer or Brexpiprazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Brexpiprazole manufacturer or Brexpiprazole supplier.
PharmaCompass also assists you with knowing the Brexpiprazole API Price utilized in the formulation of products. Brexpiprazole API Price is not always fixed or binding as the Brexpiprazole Price is obtained through a variety of data sources. The Brexpiprazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A REXULTI manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of REXULTI, including repackagers and relabelers. The FDA regulates REXULTI manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. REXULTI 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 REXULTI manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A REXULTI supplier is an individual or a company that provides REXULTI active pharmaceutical ingredient (API) or REXULTI finished formulations upon request. The REXULTI suppliers may include REXULTI API manufacturers, exporters, distributors and traders.
click here to find a list of REXULTI suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A REXULTI DMF (Drug Master File) is a document detailing the whole manufacturing process of REXULTI active pharmaceutical ingredient (API) in detail. Different forms of REXULTI DMFs exist exist since differing nations have different regulations, such as REXULTI USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A REXULTI DMF submitted to regulatory agencies in the US is known as a USDMF. REXULTI USDMF includes data on REXULTI's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The REXULTI USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of REXULTI 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 REXULTI Drug Master File in Korea (REXULTI KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of REXULTI. The MFDS reviews the REXULTI KDMF as part of the drug registration process and uses the information provided in the REXULTI KDMF to evaluate the safety and efficacy of the drug.
After submitting a REXULTI 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 REXULTI API can apply through the Korea Drug Master File (KDMF).
click here to find a list of REXULTI suppliers with KDMF on PharmaCompass.
A REXULTI written confirmation (REXULTI WC) is an official document issued by a regulatory agency to a REXULTI manufacturer, verifying that the manufacturing facility of a REXULTI active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting REXULTI APIs or REXULTI finished pharmaceutical products to another nation, regulatory agencies frequently require a REXULTI WC (written confirmation) as part of the regulatory process.
click here to find a list of REXULTI 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 REXULTI as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for REXULTI 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 REXULTI 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 REXULTI and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a REXULTI NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of REXULTI suppliers with NDC on PharmaCompass.
REXULTI 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 REXULTI 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 REXULTI GMP manufacturer or REXULTI GMP API supplier for your needs.
A REXULTI CoA (Certificate of Analysis) is a formal document that attests to REXULTI's compliance with REXULTI specifications and serves as a tool for batch-level quality control.
REXULTI CoA mostly includes findings from lab analyses of a specific batch. For each REXULTI 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.
REXULTI may be tested according to a variety of international standards, such as European Pharmacopoeia (REXULTI EP), REXULTI JP (Japanese Pharmacopeia) and the US Pharmacopoeia (REXULTI USP).
