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PharmaCompass offers a list of Aripiprazole 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 Aripiprazole manufacturer or Aripiprazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Aripiprazole manufacturer or Aripiprazole supplier.
PharmaCompass also assists you with knowing the Aripiprazole API Price utilized in the formulation of products. Aripiprazole API Price is not always fixed or binding as the Aripiprazole Price is obtained through a variety of data sources. The Aripiprazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Abilify manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Abilify, including repackagers and relabelers. The FDA regulates Abilify manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Abilify 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 Abilify manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Abilify supplier is an individual or a company that provides Abilify active pharmaceutical ingredient (API) or Abilify finished formulations upon request. The Abilify suppliers may include Abilify API manufacturers, exporters, distributors and traders.
click here to find a list of Abilify suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Abilify DMF (Drug Master File) is a document detailing the whole manufacturing process of Abilify active pharmaceutical ingredient (API) in detail. Different forms of Abilify DMFs exist exist since differing nations have different regulations, such as Abilify USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Abilify DMF submitted to regulatory agencies in the US is known as a USDMF. Abilify USDMF includes data on Abilify's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Abilify USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Abilify suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Abilify Drug Master File in Japan (Abilify JDMF) empowers Abilify API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Abilify JDMF during the approval evaluation for pharmaceutical products. At the time of Abilify JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Abilify suppliers with JDMF 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 Abilify Drug Master File in Korea (Abilify KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Abilify. The MFDS reviews the Abilify KDMF as part of the drug registration process and uses the information provided in the Abilify KDMF to evaluate the safety and efficacy of the drug.
After submitting a Abilify 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 Abilify API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Abilify suppliers with KDMF on PharmaCompass.
A Abilify CEP of the European Pharmacopoeia monograph is often referred to as a Abilify Certificate of Suitability (COS). The purpose of a Abilify CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Abilify EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Abilify to their clients by showing that a Abilify CEP has been issued for it. The manufacturer submits a Abilify CEP (COS) as part of the market authorization procedure, and it takes on the role of a Abilify CEP holder for the record. Additionally, the data presented in the Abilify CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Abilify DMF.
A Abilify CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Abilify CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Abilify suppliers with CEP (COS) on PharmaCompass.
A Abilify written confirmation (Abilify WC) is an official document issued by a regulatory agency to a Abilify manufacturer, verifying that the manufacturing facility of a Abilify active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Abilify APIs or Abilify finished pharmaceutical products to another nation, regulatory agencies frequently require a Abilify WC (written confirmation) as part of the regulatory process.
click here to find a list of Abilify 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 Abilify as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Abilify 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 Abilify 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 Abilify and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Abilify NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Abilify suppliers with NDC on PharmaCompass.
Abilify 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 Abilify 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 Abilify GMP manufacturer or Abilify GMP API supplier for your needs.
A Abilify CoA (Certificate of Analysis) is a formal document that attests to Abilify's compliance with Abilify specifications and serves as a tool for batch-level quality control.
Abilify CoA mostly includes findings from lab analyses of a specific batch. For each Abilify 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.
Abilify may be tested according to a variety of international standards, such as European Pharmacopoeia (Abilify EP), Abilify JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Abilify USP).
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