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API SUPPLIERS
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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 offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2014-08-01
Pay. Date : 2014-04-08
DMF Number : 28178
Submission : 2014-04-28
Status :
Type : II
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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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REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
A Lurasidone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lurasidone, including repackagers and relabelers. The FDA regulates Lurasidone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lurasidone 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lurasidone supplier is an individual or a company that provides Lurasidone active pharmaceutical ingredient (API) or Lurasidone finished formulations upon request. The Lurasidone suppliers may include Lurasidone API manufacturers, exporters, distributors and traders.
click here to find a list of Lurasidone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lurasidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Lurasidone active pharmaceutical ingredient (API) in detail. Different forms of Lurasidone DMFs exist exist since differing nations have different regulations, such as Lurasidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lurasidone DMF submitted to regulatory agencies in the US is known as a USDMF. Lurasidone USDMF includes data on Lurasidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lurasidone USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lurasidone 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 Drug Master File in Japan (Lurasidone JDMF) empowers Lurasidone 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Lurasidone 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 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 Drug Master File in Korea (Lurasidone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lurasidone. The MFDS reviews the Lurasidone KDMF as part of the drug registration process and uses the information provided in the Lurasidone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lurasidone 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lurasidone suppliers with KDMF on PharmaCompass.
A Lurasidone written confirmation (Lurasidone WC) is an official document issued by a regulatory agency to a Lurasidone manufacturer, verifying that the manufacturing facility of a Lurasidone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lurasidone APIs or Lurasidone finished pharmaceutical products to another nation, regulatory agencies frequently require a Lurasidone WC (written confirmation) as part of the regulatory process.
click here to find a list of Lurasidone 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lurasidone 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lurasidone NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lurasidone suppliers with NDC on PharmaCompass.
Lurasidone 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 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 GMP manufacturer or Lurasidone GMP API supplier for your needs.
A Lurasidone CoA (Certificate of Analysis) is a formal document that attests to Lurasidone's compliance with Lurasidone specifications and serves as a tool for batch-level quality control.
Lurasidone CoA mostly includes findings from lab analyses of a specific batch. For each Lurasidone 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Lurasidone EP), Lurasidone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lurasidone USP).
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