Synopsis
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CEP/COS
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JDMF
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KDMF
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VMF
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EDQM
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USP
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JP
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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.
With Fermion, start the journey of your innovative API.
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.
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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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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...
With Fermion, start the journey of your innovative API.
About the Company : Fermion, a wholly owned subsidiary of Orion Corporation and headquartered in Espoo, Finland, is a fully integrated CDMO offering API and formulation services. Its API portfolio inc...
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Tert-butyl N-[(2S)-6-[(2-methylpropan-2-yl)oxycarb...
CAS Number : 819871-13-1
End Use API : Lisdexamfetamine Dimesylate
About The Company : Cohance Lifesciences is a leading CDMO and API platform delivering products and services across the full molecule lifecycle, from development to commercializati...
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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Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name : Lisdexamfetamine
Dosage Form : Oral-Dispersible Table...
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.
Regulatory Info :
Registration Country : France
Brand Name : Lisdexamfetamine
Dosage Form : Oral-Dispersible Table...
Dosage Strength : 70MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Temad- We think of world-class quality.
Regulatory Info :
Registration Country : Iran
Brand Name :
Dosage Form : Syrup
Dosage Strength : 10MG/1ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Lisdexamfetamine Dimes...
Dosage Form : Immediate Release Chew...
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Lisdexamfetamine Dimes...
Dosage Form : Immediate Release Chew...
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Lisdexamfetamine Dimes...
Dosage Form : Immediate Release Chew...
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Lisdexamfetamine Dimes...
Dosage Form : Immediate Release Chew...
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Lisdexamfetamine Dimes...
Dosage Form : Immediate Release Caps...
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Lisdexamfetamine Dimes...
Dosage Form : Immediate Release Caps...
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info :
Registration Country : India
Brand Name : Lisdexamfetamine Dimes...
Dosage Form : Immediate Release Caps...
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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ABOUT THIS PAGE
21
PharmaCompass offers a list of Lisdexamfetamine Dimesylate 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 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.
A Vyvanse manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vyvanse, including repackagers and relabelers. The FDA regulates Vyvanse manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vyvanse 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 Vyvanse manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Vyvanse supplier is an individual or a company that provides Vyvanse active pharmaceutical ingredient (API) or Vyvanse finished formulations upon request. The Vyvanse suppliers may include Vyvanse API manufacturers, exporters, distributors and traders.
click here to find a list of Vyvanse suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Vyvanse DMF (Drug Master File) is a document detailing the whole manufacturing process of Vyvanse active pharmaceutical ingredient (API) in detail. Different forms of Vyvanse DMFs exist exist since differing nations have different regulations, such as Vyvanse USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vyvanse DMF submitted to regulatory agencies in the US is known as a USDMF. Vyvanse USDMF includes data on Vyvanse's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vyvanse USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vyvanse suppliers with USDMF on PharmaCompass.
A Vyvanse written confirmation (Vyvanse WC) is an official document issued by a regulatory agency to a Vyvanse manufacturer, verifying that the manufacturing facility of a Vyvanse active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vyvanse APIs or Vyvanse finished pharmaceutical products to another nation, regulatory agencies frequently require a Vyvanse WC (written confirmation) as part of the regulatory process.
click here to find a list of Vyvanse 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 Vyvanse as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vyvanse 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 Vyvanse 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 Vyvanse and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vyvanse NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vyvanse suppliers with NDC on PharmaCompass.
Vyvanse 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 Vyvanse GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Vyvanse GMP manufacturer or Vyvanse GMP API supplier for your needs.
A Vyvanse CoA (Certificate of Analysis) is a formal document that attests to Vyvanse's compliance with Vyvanse specifications and serves as a tool for batch-level quality control.
Vyvanse CoA mostly includes findings from lab analyses of a specific batch. For each Vyvanse 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.
Vyvanse may be tested according to a variety of international standards, such as European Pharmacopoeia (Vyvanse EP), Vyvanse JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vyvanse USP).
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