Synopsis
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CEP/COS
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South Africa
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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API SUPPLIERS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
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NDC
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Veranova: A CDMO that manages complexity with confidence.
NDC
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
EU-WC
NDC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
NDC
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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USDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34756
Submission : 2020-07-14
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-07
Pay. Date : 2019-12-03
DMF Number : 34255
Submission : 2020-01-31
Status :
Type : II
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31801
Submission : 2017-06-06
Status :
Type : II
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Complete
Rev. Date : 2014-10-06
Pay. Date : 2014-08-05
DMF Number : 26700
Submission : 2013-03-22
Status :
Type : II
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29794
Submission : 2016-05-07
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 : 2014-08-01
Pay. Date : 2014-04-08
DMF Number : 28178
Submission : 2014-04-28
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-23
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No. 34B, 40B & 60B, J.N Pharma City, Thanam (V), Parawada (M), Ana...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Date of Issue : 2022-08-25
Valid Till : 2025-07-02
Written Confirmation Number : WC-0195
Address of the Firm : Plot No. 3102/B, GIDC, Industrial Estate, Ankleshwar-393 002, Bharuch, Gujarat I...
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2022-06-17
Valid Till : 2025-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL - 120MG
USFDA APPLICATION NUMBER - 200603
DOSAGE - TABLET;ORAL - 20MG
USFDA APPLICATION NUMBER - 200603
DOSAGE - TABLET;ORAL - 40MG
USFDA APPLICATION NUMBER - 200603
DOSAGE - TABLET;ORAL - 60MG
USFDA APPLICATION NUMBER - 200603
DOSAGE - TABLET;ORAL - 80MG
USFDA APPLICATION NUMBER - 200603
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Global Sales Information
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REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
18
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 latuda manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of latuda, including repackagers and relabelers. The FDA regulates latuda manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. latuda 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 latuda manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A latuda supplier is an individual or a company that provides latuda active pharmaceutical ingredient (API) or latuda finished formulations upon request. The latuda suppliers may include latuda API manufacturers, exporters, distributors and traders.
click here to find a list of latuda suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A latuda DMF (Drug Master File) is a document detailing the whole manufacturing process of latuda active pharmaceutical ingredient (API) in detail. Different forms of latuda DMFs exist exist since differing nations have different regulations, such as latuda USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A latuda DMF submitted to regulatory agencies in the US is known as a USDMF. latuda USDMF includes data on latuda's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The latuda USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of latuda 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 latuda Drug Master File in Japan (latuda JDMF) empowers latuda 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 latuda JDMF during the approval evaluation for pharmaceutical products. At the time of latuda 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 latuda 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 latuda Drug Master File in Korea (latuda KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of latuda. The MFDS reviews the latuda KDMF as part of the drug registration process and uses the information provided in the latuda KDMF to evaluate the safety and efficacy of the drug.
After submitting a latuda 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 latuda API can apply through the Korea Drug Master File (KDMF).
click here to find a list of latuda suppliers with KDMF on PharmaCompass.
A latuda written confirmation (latuda WC) is an official document issued by a regulatory agency to a latuda manufacturer, verifying that the manufacturing facility of a latuda active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting latuda APIs or latuda finished pharmaceutical products to another nation, regulatory agencies frequently require a latuda WC (written confirmation) as part of the regulatory process.
click here to find a list of latuda 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 latuda as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for latuda 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 latuda 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 latuda and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a latuda NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of latuda suppliers with NDC on PharmaCompass.
latuda 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 latuda 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 latuda GMP manufacturer or latuda GMP API supplier for your needs.
A latuda CoA (Certificate of Analysis) is a formal document that attests to latuda's compliance with latuda specifications and serves as a tool for batch-level quality control.
latuda CoA mostly includes findings from lab analyses of a specific batch. For each latuda 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.
latuda may be tested according to a variety of international standards, such as European Pharmacopoeia (latuda EP), latuda JP (Japanese Pharmacopeia) and the US Pharmacopoeia (latuda USP).
