Synopsis
0
CEP/COS
0
VMF
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Click Us!
NDC
Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.
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
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
EU-WC
NDC
With Virupaksha, you get a quality product with on-time delivery.
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.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
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
Related Excipient Companies
Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175 µm, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170 µm, Tapped Density: 0.80
Ingredient(s) : Magnesium Hydroxide Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Keval Exports
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]Nitika Pharmaceutical Specialities
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Disintegrants & Superdisintegrants
Direct Compression
Chewable & Orodispersible Aids
Taste Masking
Co-Processed Excipients
Lubricants & Glidants
Granulation
Parenteral
Thickeners and Stabilizers
Solubilizers
Controlled & Modified Release
Rheology Modifiers
Emulsifying Agents
Coating Systems & Additives
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
APIs
Reply
14 Dec 2022
Reply
31 Oct 2022
Reply
29 Jul 2022
Reply
24 Jun 2022
Reply
13 Dec 2021
Reply
28 Mar 2020
Reply
01 Oct 2019
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
USP
ANALYTICAL
ABOUT THIS PAGE
19
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 Latuda (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Latuda (TN), including repackagers and relabelers. The FDA regulates Latuda (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Latuda (TN) 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 (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Latuda (TN) supplier is an individual or a company that provides Latuda (TN) active pharmaceutical ingredient (API) or Latuda (TN) finished formulations upon request. The Latuda (TN) suppliers may include Latuda (TN) API manufacturers, exporters, distributors and traders.
click here to find a list of Latuda (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Latuda (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Latuda (TN) active pharmaceutical ingredient (API) in detail. Different forms of Latuda (TN) DMFs exist exist since differing nations have different regulations, such as Latuda (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Latuda (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Latuda (TN) USDMF includes data on Latuda (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Latuda (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Latuda (TN) 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 (TN) Drug Master File in Japan (Latuda (TN) JDMF) empowers Latuda (TN) 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 (TN) JDMF during the approval evaluation for pharmaceutical products. At the time of Latuda (TN) 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 (TN) 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 (TN) Drug Master File in Korea (Latuda (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Latuda (TN). The MFDS reviews the Latuda (TN) KDMF as part of the drug registration process and uses the information provided in the Latuda (TN) KDMF to evaluate the safety and efficacy of the drug.
After submitting a Latuda (TN) 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 (TN) API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Latuda (TN) suppliers with KDMF on PharmaCompass.
A Latuda (TN) written confirmation (Latuda (TN) WC) is an official document issued by a regulatory agency to a Latuda (TN) manufacturer, verifying that the manufacturing facility of a Latuda (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Latuda (TN) APIs or Latuda (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Latuda (TN) WC (written confirmation) as part of the regulatory process.
click here to find a list of Latuda (TN) 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 (TN) as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Latuda (TN) 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 (TN) 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 (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Latuda (TN) NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Latuda (TN) suppliers with NDC on PharmaCompass.
Latuda (TN) 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 (TN) 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 (TN) GMP manufacturer or Latuda (TN) GMP API supplier for your needs.
A Latuda (TN) CoA (Certificate of Analysis) is a formal document that attests to Latuda (TN)'s compliance with Latuda (TN) specifications and serves as a tool for batch-level quality control.
Latuda (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Latuda (TN) 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 (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Latuda (TN) EP), Latuda (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Latuda (TN) USP).
Comment (7)
