Synopsis
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CEP/COS
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JDMF
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KDMF
0
VMF
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EDQM
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USP
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JP
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Others
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC 
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
BR
Temad- We think of world-class quality.
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Veranova: A CDMO that manages complexity with confidence.
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2020-01-28
Pay. Date : 2020-01-21
DMF Number : 22442
Submission : 2009-01-27
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2023-11-21
Pay. Date : 2023-10-12
DMF Number : 38874
Submission : 2023-10-20
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2021-12-30
Pay. Date : 2021-11-18
DMF Number : 35645
Submission : 2021-11-23
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 : 42282
Submission : 2025-07-11
Status :
Type : II
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Noramco, founded in 1979, specializes in developing and manufacturing APIs for opioid and non-opioid products. It excels in controlled substance development, offering supply-chain ...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited, established in 1987 and headquartered in Mumbai, is a globally recognized, technology-driven manufacturer of APIs, CDMO, and formulations. Its faciliti...
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...
Temad- We think of world-class quality.
About the Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. It complies with Ira...
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
About the Company : Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top API manufacturer in th...
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
About the Company : Since 1962, MOEHS has produced high-quality Active Pharmaceutical Ingredients (APIs) for the global market. With decades of technical expertise, Moehs Group delivers pharmaceutical...
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
About the Company : Siegfried is a global Contract Development and Manufacturing Organization providing integrated services for pharmaceutical ingredients & finished dosage forms. With 13 production s...
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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) : Lisdexamfetamine Dimesylate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules Strengthens ADHD Portfolio with FDA Approval for Lisdexamfetamine Dimesylate
Details : FDA approved Lisdexamfetamine Dimesylate Capsules, a bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder.
Product Name : Vyvanse-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
January 30, 2025
Lead Product(s) : Lisdexamfetamine Dimesylate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Limited Announces FDA Approval for ADHD Treatment
Details : FDA approved Lisdexamfetamine Dimesylate Tablets, a bioequivalent and therapeutically equivalent to the reference listed drug, Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder.
Product Name : Vyvanse-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
December 17, 2024
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Suanfarma, at the Core of a Better Life.
CAS Number : 2592-19-0
End Use API : Lisdexamfetamine Dimesylate
About The Company : Suanfarma is a B2B life sciences company focused on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an i...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Lisdexamfetamin Orion Pharma
Dosage Form : Capsule
Dosage Strength : 20mg
Packaging :
Approval Date : 04/01/2024
Application Number : 20221130000140
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Lisdexamfetamin Orion Pharma
Dosage Form : Capsule
Dosage Strength : 50mg
Packaging :
Approval Date : 04/01/2024
Application Number : 20221130000171
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Lisdexamfetamine Orion
Dosage Form : Capsule
Dosage Strength : 20mg
Packaging :
Approval Date : 30/01/2023
Application Number : 20210831000115
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Lisdexamfetamine Orion
Dosage Form : Capsule
Dosage Strength : 30mg
Packaging :
Approval Date : 30/01/2023
Application Number : 20210831000122
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Lisdexamfetamine Orion
Dosage Form : Capsule
Dosage Strength : 50mg
Packaging :
Approval Date : 30/01/2023
Application Number : 20210831000146
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Lisdexamfetamine Orion
Dosage Form : Capsule
Dosage Strength : 60mg
Packaging :
Approval Date : 30/01/2023
Application Number : 20210831000153
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lisdexamfetamindimesylate \"Orion Pharma\"
Dosage Form : Hard Capsules
Dosage Strength : 20mg
Packaging :
Approval Date : 15-04-2024
Application Number : 28106882422
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lisdexamfetamine \"Orion\"
Dosage Form : Hard Capsules
Dosage Strength : 20mg
Packaging :
Approval Date : 24-05-2023
Application Number : 28106668921
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lisdexamfetamindimesylate \"Orion Pharma\"
Dosage Form : Hard Capsules
Dosage Strength : 40mg
Packaging :
Approval Date : 15-04-2024
Application Number : 28106882622
Regulatory Info : Prescription
Registration Country : Denmark
Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Lisdexamfetamine \"Orion\"
Dosage Form : Hard Capsules
Dosage Strength : 50mg
Packaging :
Approval Date : 24-05-2023
Application Number : 28106669221
Regulatory Info : Prescription
Registration Country : Denmark
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DOSAGE - CAPSULE;ORAL - 10MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 20MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 30MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 40MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 50MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 60MG
USFDA APPLICATION NUMBER - 21977
DOSAGE - CAPSULE;ORAL - 70MG
USFDA APPLICATION NUMBER - 21977
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Granulation
Co-Processed Excipients
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ABOUT THIS PAGE
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PharmaCompass offers a list of Lisdexamfetamine Dimesylate 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 Lisdexamfetamine Dimesylate manufacturer or Lisdexamfetamine Dimesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lisdexamfetamine Dimesylate manufacturer or Lisdexamfetamine Dimesylate supplier.
PharmaCompass also assists you with knowing the Lisdexamfetamine Dimesylate API Price utilized in the formulation of products. Lisdexamfetamine Dimesylate API Price is not always fixed or binding as the Lisdexamfetamine Dimesylate Price is obtained through a variety of data sources. The Lisdexamfetamine Dimesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A elvanse manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of elvanse, including repackagers and relabelers. The FDA regulates elvanse manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. elvanse 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 elvanse manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A elvanse supplier is an individual or a company that provides elvanse active pharmaceutical ingredient (API) or elvanse finished formulations upon request. The elvanse suppliers may include elvanse API manufacturers, exporters, distributors and traders.
click here to find a list of elvanse suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A elvanse DMF (Drug Master File) is a document detailing the whole manufacturing process of elvanse active pharmaceutical ingredient (API) in detail. Different forms of elvanse DMFs exist exist since differing nations have different regulations, such as elvanse USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A elvanse DMF submitted to regulatory agencies in the US is known as a USDMF. elvanse USDMF includes data on elvanse's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The elvanse USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of elvanse suppliers with USDMF on PharmaCompass.
A elvanse written confirmation (elvanse WC) is an official document issued by a regulatory agency to a elvanse manufacturer, verifying that the manufacturing facility of a elvanse active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting elvanse APIs or elvanse finished pharmaceutical products to another nation, regulatory agencies frequently require a elvanse WC (written confirmation) as part of the regulatory process.
click here to find a list of elvanse 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 elvanse as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for elvanse 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 elvanse 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 elvanse and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a elvanse NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of elvanse suppliers with NDC on PharmaCompass.
elvanse 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 elvanse 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 elvanse GMP manufacturer or elvanse GMP API supplier for your needs.
A elvanse CoA (Certificate of Analysis) is a formal document that attests to elvanse's compliance with elvanse specifications and serves as a tool for batch-level quality control.
elvanse CoA mostly includes findings from lab analyses of a specific batch. For each elvanse 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.
elvanse may be tested according to a variety of international standards, such as European Pharmacopoeia (elvanse EP), elvanse JP (Japanese Pharmacopeia) and the US Pharmacopoeia (elvanse USP).
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