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