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
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API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
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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.
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.
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 : 2023-11-21
Pay. Date : 2023-10-12
DMF Number : 38874
Submission : 2023-10-20
Status :
Type : II
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
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
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Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Limited is a globally recognized, technology-driven manufacturer of APIs , CDMO & formulations, established in 1987. Headquartered in Mumbai, India, we operate ...
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, offering products and services across all phases of a molecule’s lifecycle from development to commercialzation. With our...
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...
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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
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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 dedicated to health and advancement. To achieve this, the company focuses on developing, manufacturing, and distributin...
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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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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 Lisdexamfetamine Dimesylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lisdexamfetamine Dimesylate, including repackagers and relabelers. The FDA regulates Lisdexamfetamine Dimesylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lisdexamfetamine Dimesylate 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 Lisdexamfetamine Dimesylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lisdexamfetamine Dimesylate supplier is an individual or a company that provides Lisdexamfetamine Dimesylate active pharmaceutical ingredient (API) or Lisdexamfetamine Dimesylate finished formulations upon request. The Lisdexamfetamine Dimesylate suppliers may include Lisdexamfetamine Dimesylate API manufacturers, exporters, distributors and traders.
click here to find a list of Lisdexamfetamine Dimesylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lisdexamfetamine Dimesylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Lisdexamfetamine Dimesylate active pharmaceutical ingredient (API) in detail. Different forms of Lisdexamfetamine Dimesylate DMFs exist exist since differing nations have different regulations, such as Lisdexamfetamine Dimesylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lisdexamfetamine Dimesylate DMF submitted to regulatory agencies in the US is known as a USDMF. Lisdexamfetamine Dimesylate USDMF includes data on Lisdexamfetamine Dimesylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lisdexamfetamine Dimesylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lisdexamfetamine Dimesylate suppliers with USDMF on PharmaCompass.
A Lisdexamfetamine Dimesylate written confirmation (Lisdexamfetamine Dimesylate WC) is an official document issued by a regulatory agency to a Lisdexamfetamine Dimesylate manufacturer, verifying that the manufacturing facility of a Lisdexamfetamine Dimesylate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lisdexamfetamine Dimesylate APIs or Lisdexamfetamine Dimesylate finished pharmaceutical products to another nation, regulatory agencies frequently require a Lisdexamfetamine Dimesylate WC (written confirmation) as part of the regulatory process.
click here to find a list of Lisdexamfetamine Dimesylate 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 Lisdexamfetamine Dimesylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lisdexamfetamine Dimesylate 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 Lisdexamfetamine Dimesylate 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 Lisdexamfetamine Dimesylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lisdexamfetamine Dimesylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lisdexamfetamine Dimesylate suppliers with NDC on PharmaCompass.
Lisdexamfetamine Dimesylate 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 Lisdexamfetamine Dimesylate 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 Lisdexamfetamine Dimesylate GMP manufacturer or Lisdexamfetamine Dimesylate GMP API supplier for your needs.
A Lisdexamfetamine Dimesylate CoA (Certificate of Analysis) is a formal document that attests to Lisdexamfetamine Dimesylate's compliance with Lisdexamfetamine Dimesylate specifications and serves as a tool for batch-level quality control.
Lisdexamfetamine Dimesylate CoA mostly includes findings from lab analyses of a specific batch. For each Lisdexamfetamine Dimesylate 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.
Lisdexamfetamine Dimesylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Lisdexamfetamine Dimesylate EP), Lisdexamfetamine Dimesylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lisdexamfetamine Dimesylate USP).
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