Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
CEP/COS
NDC
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
With Virupaksha, you get a quality product with on-time delivery.
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
SNJ Labs: WHO-GMP certified API leader in India, specializing in bulk drugs & intermediates with unmatched expertise.
Together we can improve the quality of life
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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 : 38789
Submission : 2023-09-28
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 : 2013-03-14
Pay. Date : 2012-10-25
DMF Number : 26381
Submission : 2012-09-27
Status :
Type : II
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Shandong Loncom is an R&D-focused manufacturer of Anti-cancer APIs.
Certificate Number : R0-CEP 2021-451 - Rev 01
Status : Valid
Issue Date : 2023-05-16
Type : Chemical
Substance Number : 2992
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Certificate Number : CEP 2023-365 - Rev 01
Status : Valid
Issue Date : 2025-01-14
Type : Chemical
Substance Number : 2992
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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
Lead Product(s) : Lacosamide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Aucta Launches MOTPOLY XR, the First Once-Daily Lacosamide Formulation
Details : Motpoly (lacosamide) is an antiepileptic drug that works by blocking sodium channel alpha subunit. It is being evaluated for partial-onset seizures in adults and in pediatric patients.
Product Name : Motpoly XR
Product Type : Controlled Substance
Upfront Cash : Inapplicable
February 26, 2024
Lead Product(s) : Lacosamide,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Lacosamide is a functionalized amino acid that has activity in the maximal electroshock seizure test, and is indicated for the adjunctive treatment of partial-onset seizures and diabetic neuropathic pain.
Product Name : Lacosamide-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
March 22, 2022
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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 - 100MG
USFDA APPLICATION NUMBER - 22253
DOSAGE - TABLET;ORAL - 150MG
USFDA APPLICATION NUMBER - 22253
DOSAGE - TABLET;ORAL - 200MG
USFDA APPLICATION NUMBER - 22253
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 22253
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Fillers, Diluents & Binders
Thickeners and Stabilizers
Controlled & Modified Release
Film Formers & Plasticizers
Topical
Parenteral
Lubricants & Glidants
Taste Masking
Solubilizers
Direct Compression
Rheology Modifiers
Co-Processed Excipients
Disintegrants & Superdisintegrants
Granulation
Chewable & Orodispersible Aids
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Coloring Agents
Vegetarian Capsules
Soft Gelatin
Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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US Patents
Aucta is a global brand that creates better products from proven molecules.
Patent Expiration Date : 2040-06-05
US Patent Number : 12042474
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216185
Patent Use Code : U-3660
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-05
Aucta is a global brand that creates better products from proven molecules.
Patent Expiration Date : 2040-06-05
US Patent Number : 11337943
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216185
Patent Use Code : U-3954
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-05
Aucta is a global brand that creates better products from proven molecules.
Patent Expiration Date : 2040-06-05
US Patent Number : 11883374
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216185
Patent Use Code : U-3660
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-05
Aucta is a global brand that creates better products from proven molecules.
Patent Expiration Date : 2040-06-05
US Patent Number : 12042474
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216185
Patent Use Code : U-3954
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-05
Aucta is a global brand that creates better products from proven molecules.
Patent Expiration Date : 2040-06-05
US Patent Number : 11337943
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216185
Patent Use Code : U-3954
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-05
Aucta is a global brand that creates better products from proven molecules.
Patent Expiration Date : 2040-06-05
US Patent Number : 12042474
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216185
Patent Use Code : U-3954
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-05
Aucta is a global brand that creates better products from proven molecules.
Patent Expiration Date : 2040-06-05
US Patent Number : 11337943
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216185
Patent Use Code : U-3954
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-05
Aucta is a global brand that creates better products from proven molecules.
Patent Expiration Date : 2040-06-05
US Patent Number : 12042474
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216185
Patent Use Code : U-3954
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-05
Aucta is a global brand that creates better products from proven molecules.
Patent Expiration Date : 2040-06-05
US Patent Number : 12042474
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216185
Patent Use Code : U-3660
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-05
Aucta is a global brand that creates better products from proven molecules.
Patent Expiration Date : 2040-06-05
US Patent Number : 11883374
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 216185
Patent Use Code : U-3660
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2040-06-05
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
USP
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
CAS Number : 388619-64-5
Quantity Per Vial :
Price ($) : 450
Catalog Number : 1A02310
Current Lot : 25 mg
Previous Lot :
NDC Code :
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
CAS Number : 2295925-90-3
Quantity Per Vial :
Price ($) : 1900
Catalog Number : 1A01820
Current Lot : 25 mg
Previous Lot :
NDC Code :
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
N-Benzylacetamide (N-Acetylbenzylamine)
CAS Number : 588-46-5
Quantity Per Vial :
Price ($) : 700
Catalog Number : 1A01810
Current Lot : 25 mg
Previous Lot :
NDC Code :
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
CAS Number : 86921-49-5
Quantity Per Vial :
Price ($) : 700
Catalog Number : 1A01800
Current Lot : 25 mg
Previous Lot :
NDC Code :
USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.
CAS Number : 2742962-60-1
Quantity Per Vial :
Price ($) : 2000
Catalog Number : 1A01790
Current Lot : 25 mg
Previous Lot :
NDC Code :
ABOUT THIS PAGE
83
PharmaCompass offers a list of Lacosamide 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 Lacosamide manufacturer or Lacosamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lacosamide manufacturer or Lacosamide supplier.
PharmaCompass also assists you with knowing the Lacosamide API Price utilized in the formulation of products. Lacosamide API Price is not always fixed or binding as the Lacosamide Price is obtained through a variety of data sources. The Lacosamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lacosamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lacosamide, including repackagers and relabelers. The FDA regulates Lacosamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lacosamide 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 Lacosamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lacosamide supplier is an individual or a company that provides Lacosamide active pharmaceutical ingredient (API) or Lacosamide finished formulations upon request. The Lacosamide suppliers may include Lacosamide API manufacturers, exporters, distributors and traders.
click here to find a list of Lacosamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lacosamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Lacosamide active pharmaceutical ingredient (API) in detail. Different forms of Lacosamide DMFs exist exist since differing nations have different regulations, such as Lacosamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lacosamide DMF submitted to regulatory agencies in the US is known as a USDMF. Lacosamide USDMF includes data on Lacosamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lacosamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lacosamide 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 Lacosamide Drug Master File in Japan (Lacosamide JDMF) empowers Lacosamide 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 Lacosamide JDMF during the approval evaluation for pharmaceutical products. At the time of Lacosamide 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 Lacosamide 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 Lacosamide Drug Master File in Korea (Lacosamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lacosamide. The MFDS reviews the Lacosamide KDMF as part of the drug registration process and uses the information provided in the Lacosamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lacosamide 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 Lacosamide API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lacosamide suppliers with KDMF on PharmaCompass.
A Lacosamide CEP of the European Pharmacopoeia monograph is often referred to as a Lacosamide Certificate of Suitability (COS). The purpose of a Lacosamide CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lacosamide EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lacosamide to their clients by showing that a Lacosamide CEP has been issued for it. The manufacturer submits a Lacosamide CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lacosamide CEP holder for the record. Additionally, the data presented in the Lacosamide CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lacosamide DMF.
A Lacosamide CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lacosamide CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Lacosamide suppliers with CEP (COS) on PharmaCompass.
A Lacosamide written confirmation (Lacosamide WC) is an official document issued by a regulatory agency to a Lacosamide manufacturer, verifying that the manufacturing facility of a Lacosamide active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lacosamide APIs or Lacosamide finished pharmaceutical products to another nation, regulatory agencies frequently require a Lacosamide WC (written confirmation) as part of the regulatory process.
click here to find a list of Lacosamide 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 Lacosamide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lacosamide 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 Lacosamide 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 Lacosamide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lacosamide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lacosamide suppliers with NDC on PharmaCompass.
Lacosamide 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 Lacosamide 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 Lacosamide GMP manufacturer or Lacosamide GMP API supplier for your needs.
A Lacosamide CoA (Certificate of Analysis) is a formal document that attests to Lacosamide's compliance with Lacosamide specifications and serves as a tool for batch-level quality control.
Lacosamide CoA mostly includes findings from lab analyses of a specific batch. For each Lacosamide 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.
Lacosamide may be tested according to a variety of international standards, such as European Pharmacopoeia (Lacosamide EP), Lacosamide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lacosamide USP).
