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.
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Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
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...
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...
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
About the Company : Supriya Lifescience Ltd. specializes in API manufacturing, focusing on therapeutic segments like antihistamines, anti-allergic drugs, vitamins, anaesthetics and anti-asthmatics. Su...
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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
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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 founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the ...
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
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 10MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 20MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 30MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 60MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Capsule
Dosage Strength : 70MG
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
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
Related Excipient Companies
Rochem International Inc
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Direct Compression
Disintegrants & Superdisintegrants
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Brand Name : Croscarmellose Sodium
Application : Disintegrants & Superdisintegrants
Excipient Details : Croscarmellose sodium is used as a super disintegrant in various oral solid dosage forms, such as tablets and ODTs.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Capsule, Orodispersible Tablet, Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Sallyso (Croscarmellose Sodium) is a cross-linked polymer of carboxymethylcellulose sodium, used as a superdisintegrant in tablets and capsules.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : Sallyso 0.5 to 3.0%
Ingredient(s) : Croscarmellose Sodium
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Brand Name : Mannogem XL Mannitol
Application : Chewable & Orodispersible Aids, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Excipient Details : Mannogem® XL is a DC spray-dried mannitol used to enhance mannitol formulation tabletability & provide superior binding & quick disintegration.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Brand Name : Mannogem Granular
Application : Chewable & Orodispersible Aids, Direct Compression, Disintegrants & Superdisintegrants
Excipient Details : Mannogem Granular has larger particles, offering a softer texture for chewable tablets and excellent flow, disintegration, and compression properties.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Direct Compression, Disintegrants & Superdisintegrants
Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.
Co-Processed Excipients
Thickeners and Stabilizers
Taste Masking
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Pharmaburst® 500 is a directly compressible, co-processed pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Dosage Form : Capsule, Liquid, Suspension, Syrup, Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Sucralose is used as a taste-masking and sweetening agent in various formulations such as tablets, capsules, and liquids, including suspensions.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Sucrex (Sucralose) is used as a sweetener and a taste masking agent in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...
Technical Specs : NA
Ingredient(s) : Sucralose
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Sucralose is an immediate-release polymer used as a taste masking & coating agent to improve swallowability of tablets and ODTs.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Capsule, Liquid, Suspension, Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Sucralose is a nonnutritive, zero-calorie sweetener, used as taste masking agent in various formulations such as tablets, capsules & suspensions.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet, Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids, Taste Masking
Excipient Details : Pharmasperse® 416 is a versatile DDS comprised of mannitol excipients and is specifically engineered for orally dispersible powder (ODP) formulations.
Chewable & Orodispersible Aids
Granulation
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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
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Application : Lubricants & Glidants
Excipient Details : Magnesium stearate is the magnesium salt of stearic acid. It acts as a lubricating agent in tablet manufacturing.
Empty Capsules
Coating Systems & Additives
Parenteral
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
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Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral, Tablet
Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.
Film Formers & Plasticizers
Coloring Agents
Controlled & Modified Release
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.
Emulsifying Agents
Rheology Modifiers
API Stability Enhancers
Solubilizers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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ABOUT THIS PAGE
41
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 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, COA and API Price 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, COA and API Price 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, API price, 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).
