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API SUPPLIERS
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USDMF
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
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
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
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
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-24
Pay. Date : 2014-01-24
DMF Number : 27898
Submission : 2014-04-30
Status :
Type : II
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-07
Pay. Date : 2014-04-29
DMF Number : 27963
Submission : 2014-04-11
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]JDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Date of Issue : 2025-07-15
Valid Till : 2028-07-07
Written Confirmation Number : WC-0067
Address of the Firm : Chemical Technical Operation
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-03
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), An...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]KDMF
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
About the Company : Founded in 1984, DRL is well-known for its generic APIs and its track record in drug product development. It is one of the earliest pharma API manufacturers with a diverse portfoli...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in developing and manufacturing specialist and complex APIs for pharma and biotech customers, with over 50 years of experience supporting the healthcare...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
About the Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercialization. With strong expe...
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
About the Company : HRV Pharma is a global manufacturer, seller, and exporter of APIs, intermediates, pellets, food-grade chemicals, food additives, and food ingredients. The company provides sourcing...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
About the Company : AMSA S.p.A, founded in 1953 near Italy’s iconic Lake Como, is the founding manufacturing company of the CFM Group. With a modernized facility and over six decades of experience, ...
Lupin Manufacturing Solutions – delivering high-quality APIs & end-to-end CDMO services for faster, cost-effective drug development.
About the Company : Lupin Manufacturing Solutions (LMS), a wholly owned Lupin subsidiary, offers high-quality APIs and end-to-end CDMO services from R&D to commercial scale. Backed by five decades of ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
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API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
With Virupaksha, you get a quality product with on-time delivery.
(1R,2R)-1,2-Cyclohexanedimethanol
CAS Number : 65376-05-8
End Use API : Lurasidone Hydrochloride
About The Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylar...
With Virupaksha, you get a quality product with on-time delivery.
((1R,2R)-2-{[Methyl Sulphonyl]methyl}Cyclohexyl)Me...
CAS Number : 66347-68-0
End Use API : Lurasidone Hydrochloride
About The Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylar...
With Virupaksha, you get a quality product with on-time delivery.
(3aR,4S,7R,7aS) 4,7-Methano-1H-isoindole-1,3(2H)-d...
CAS Number : 14805-29-9
End Use API : Lurasidone Hydrochloride
About The Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylar...
With Virupaksha, you get a quality product with on-time delivery.
(R,R)-1,2-Bis(methanesulfonyloxymethyl)cyclohexane
CAS Number : 186204-35-3
End Use API : Lurasidone Hydrochloride
About The Company : Virupaksha Organics, founded in 2003, is a leading manufacturer of APIs and intermediates. Its FDA-audited, ISO-certified facilities in Kazipally and Pashamylar...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Neelkanth MineChem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nitika Pharmaceutical Specialities
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
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Disintegrants & Superdisintegrants
Direct Compression
Chewable & Orodispersible Aids
Taste Masking
Lubricants & Glidants
Co-Processed Excipients
Granulation
Parenteral
Thickeners and Stabilizers
Emulsifying Agents
Solubilizers
Rheology Modifiers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
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, Price,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.
PharmaCompass also assists you with knowing the Lurasidone Hydrochloride API Price utilized in the formulation of products. Lurasidone Hydrochloride API Price is not always fixed or binding as the Lurasidone Hydrochloride Price is obtained through a variety of data sources. The Lurasidone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lurasidone HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lurasidone HCl, including repackagers and relabelers. The FDA regulates Lurasidone HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lurasidone HCl 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 HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lurasidone HCl supplier is an individual or a company that provides Lurasidone HCl active pharmaceutical ingredient (API) or Lurasidone HCl finished formulations upon request. The Lurasidone HCl suppliers may include Lurasidone HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Lurasidone HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lurasidone HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Lurasidone HCl active pharmaceutical ingredient (API) in detail. Different forms of Lurasidone HCl DMFs exist exist since differing nations have different regulations, such as Lurasidone HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lurasidone HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Lurasidone HCl USDMF includes data on Lurasidone HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lurasidone HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lurasidone HCl 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 HCl Drug Master File in Japan (Lurasidone HCl JDMF) empowers Lurasidone HCl 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 HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Lurasidone HCl 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 HCl 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 HCl Drug Master File in Korea (Lurasidone HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lurasidone HCl. The MFDS reviews the Lurasidone HCl KDMF as part of the drug registration process and uses the information provided in the Lurasidone HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lurasidone HCl 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 HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lurasidone HCl suppliers with KDMF on PharmaCompass.
A Lurasidone HCl written confirmation (Lurasidone HCl WC) is an official document issued by a regulatory agency to a Lurasidone HCl manufacturer, verifying that the manufacturing facility of a Lurasidone HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lurasidone HCl APIs or Lurasidone HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Lurasidone HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Lurasidone HCl 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 HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lurasidone HCl 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 HCl 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 HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lurasidone HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lurasidone HCl suppliers with NDC on PharmaCompass.
Lurasidone HCl 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 HCl 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 HCl GMP manufacturer or Lurasidone HCl GMP API supplier for your needs.
A Lurasidone HCl CoA (Certificate of Analysis) is a formal document that attests to Lurasidone HCl's compliance with Lurasidone HCl specifications and serves as a tool for batch-level quality control.
Lurasidone HCl CoA mostly includes findings from lab analyses of a specific batch. For each Lurasidone HCl 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 HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Lurasidone HCl EP), Lurasidone HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lurasidone HCl USP).
