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API SUPPLIERS
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Veranova: A CDMO that manages complexity with confidence.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Neuland Laboratories- A dedicated 100% API provider.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
NDC 
ASMF
Maithri Drugs: Dedicated to your API needs.
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USDMF
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European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Polur
Dosage Form : Film Coated Tablet
Dosage Strength : 18.5mg
Packaging :
Approval Date : 14-05-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Polur
Dosage Form : Film Coated Tablet
Dosage Strength : 37mg
Packaging :
Approval Date : 14-05-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
European CDMO and Gx manufacturer with 75 years of experience in delivering premium APIs to pharmaceutical partners worldwide.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Polur
Dosage Form : Film Coated Tablet
Dosage Strength : 74mg
Packaging :
Approval Date : 14-05-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden
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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
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ABOUT THIS PAGE
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PharmaCompass offers a list of Lurasidone Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Lurasidone Hydrochloride manufacturer or Lurasidone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lurasidone Hydrochloride manufacturer or Lurasidone Hydrochloride supplier.
A Lurasidone hydrochloride [USAN] manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lurasidone hydrochloride [USAN], including repackagers and relabelers. The FDA regulates Lurasidone hydrochloride [USAN] manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lurasidone hydrochloride [USAN] 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 [USAN] manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Lurasidone hydrochloride [USAN] supplier is an individual or a company that provides Lurasidone hydrochloride [USAN] active pharmaceutical ingredient (API) or Lurasidone hydrochloride [USAN] finished formulations upon request. The Lurasidone hydrochloride [USAN] suppliers may include Lurasidone hydrochloride [USAN] API manufacturers, exporters, distributors and traders.
click here to find a list of Lurasidone hydrochloride [USAN] suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Lurasidone hydrochloride [USAN] DMF (Drug Master File) is a document detailing the whole manufacturing process of Lurasidone hydrochloride [USAN] active pharmaceutical ingredient (API) in detail. Different forms of Lurasidone hydrochloride [USAN] DMFs exist exist since differing nations have different regulations, such as Lurasidone hydrochloride [USAN] USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lurasidone hydrochloride [USAN] DMF submitted to regulatory agencies in the US is known as a USDMF. Lurasidone hydrochloride [USAN] USDMF includes data on Lurasidone hydrochloride [USAN]'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lurasidone hydrochloride [USAN] USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lurasidone hydrochloride [USAN] 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 [USAN] Drug Master File in Japan (Lurasidone hydrochloride [USAN] JDMF) empowers Lurasidone hydrochloride [USAN] 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 [USAN] JDMF during the approval evaluation for pharmaceutical products. At the time of Lurasidone hydrochloride [USAN] 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 [USAN] 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 [USAN] Drug Master File in Korea (Lurasidone hydrochloride [USAN] KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lurasidone hydrochloride [USAN]. The MFDS reviews the Lurasidone hydrochloride [USAN] KDMF as part of the drug registration process and uses the information provided in the Lurasidone hydrochloride [USAN] KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lurasidone hydrochloride [USAN] 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 [USAN] API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lurasidone hydrochloride [USAN] suppliers with KDMF on PharmaCompass.
A Lurasidone hydrochloride [USAN] written confirmation (Lurasidone hydrochloride [USAN] WC) is an official document issued by a regulatory agency to a Lurasidone hydrochloride [USAN] manufacturer, verifying that the manufacturing facility of a Lurasidone hydrochloride [USAN] active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lurasidone hydrochloride [USAN] APIs or Lurasidone hydrochloride [USAN] finished pharmaceutical products to another nation, regulatory agencies frequently require a Lurasidone hydrochloride [USAN] WC (written confirmation) as part of the regulatory process.
click here to find a list of Lurasidone hydrochloride [USAN] 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 [USAN] as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lurasidone hydrochloride [USAN] 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 [USAN] 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 [USAN] and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lurasidone hydrochloride [USAN] NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lurasidone hydrochloride [USAN] suppliers with NDC on PharmaCompass.
Lurasidone hydrochloride [USAN] 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 [USAN] GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Lurasidone hydrochloride [USAN] GMP manufacturer or Lurasidone hydrochloride [USAN] GMP API supplier for your needs.
A Lurasidone hydrochloride [USAN] CoA (Certificate of Analysis) is a formal document that attests to Lurasidone hydrochloride [USAN]'s compliance with Lurasidone hydrochloride [USAN] specifications and serves as a tool for batch-level quality control.
Lurasidone hydrochloride [USAN] CoA mostly includes findings from lab analyses of a specific batch. For each Lurasidone hydrochloride [USAN] 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 [USAN] may be tested according to a variety of international standards, such as European Pharmacopoeia (Lurasidone hydrochloride [USAN] EP), Lurasidone hydrochloride [USAN] JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lurasidone hydrochloride [USAN] USP).
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