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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 Aripiprazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Aripiprazole, including repackagers and relabelers. The FDA regulates Aripiprazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Aripiprazole 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 Aripiprazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Aripiprazole supplier is an individual or a company that provides Aripiprazole active pharmaceutical ingredient (API) or Aripiprazole finished formulations upon request. The Aripiprazole suppliers may include Aripiprazole API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Aripiprazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Aripiprazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Aripiprazole active pharmaceutical ingredient (API) in detail. Different forms of Aripiprazole DMFs exist exist since differing nations have different regulations, such as Aripiprazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Aripiprazole DMF submitted to regulatory agencies in the US is known as a USDMF. Aripiprazole USDMF includes data on Aripiprazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Aripiprazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
CLICK HERE to find a list of Aripiprazole 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 Aripiprazole Drug Master File in Japan (Aripiprazole JDMF) empowers Aripiprazole 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 Aripiprazole JDMF during the approval evaluation for pharmaceutical products. At the time of Aripiprazole 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 Aripiprazole 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 Aripiprazole Drug Master File in Korea (Aripiprazole KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Aripiprazole. The MFDS reviews the Aripiprazole KDMF as part of the drug registration process and uses the information provided in the Aripiprazole KDMF to evaluate the safety and efficacy of the drug.
After submitting a Aripiprazole 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 Aripiprazole API can apply through the Korea Drug Master File (KDMF).
CLICK HERE to find a list of Aripiprazole suppliers with KDMF on PharmaCompass.
A Aripiprazole CEP of the European Pharmacopoeia monograph is often referred to as a Aripiprazole Certificate of Suitability (COS). The purpose of a Aripiprazole CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Aripiprazole EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Aripiprazole to their clients by showing that a Aripiprazole CEP has been issued for it. The manufacturer submits a Aripiprazole CEP (COS) as part of the market authorization procedure, and it takes on the role of a Aripiprazole CEP holder for the record. Additionally, the data presented in the Aripiprazole CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Aripiprazole DMF.
A Aripiprazole CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Aripiprazole 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 Aripiprazole suppliers with CEP (COS) on PharmaCompass.
A Aripiprazole written confirmation (Aripiprazole WC) is an official document issued by a regulatory agency to a Aripiprazole manufacturer, verifying that the manufacturing facility of a Aripiprazole active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Aripiprazole APIs or Aripiprazole finished pharmaceutical products to another nation, regulatory agencies frequently require a Aripiprazole WC (written confirmation) as part of the regulatory process.
CLICK HERE to find a list of Aripiprazole 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 Aripiprazole as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Aripiprazole 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 Aripiprazole 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 Aripiprazole and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Aripiprazole NDC to their finished compounded human drug products, they may choose to do so.
CLICK HERE to find a list of Aripiprazole suppliers with NDC on PharmaCompass.
Aripiprazole 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 Aripiprazole 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 Aripiprazole GMP manufacturer or Aripiprazole GMP API supplier for your needs.
A Aripiprazole CoA (Certificate of Analysis) is a formal document that attests to Aripiprazole's compliance with Aripiprazole specifications and serves as a tool for batch-level quality control.
Aripiprazole CoA mostly includes findings from lab analyses of a specific batch. For each Aripiprazole 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.
Aripiprazole may be tested according to a variety of international standards, such as European Pharmacopoeia (Aripiprazole EP), Aripiprazole JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Aripiprazole USP).
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