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