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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Others
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
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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.
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
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : Complete
Rev. Date : 2025-05-30
Pay. Date : 2025-05-15
DMF Number : 41737
Submission : 2025-05-17
Status :
Type : II
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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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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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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Application : Fillers, Diluents & Binders, Granulation, Solubilizers
Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
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.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Brand Name : GELATIN BOVINE 140B 6M
Application : Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Gelatin bovine 140B 6M is used as a stabilizer in parenteral drug products and as a binder and filler in capsules, tablets, granules, and pellets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
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 used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : D-Mannitol
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.
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.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Gelita RXL R² 115B BB TB Ph is used as a stabilizer in parenteral formulations and as a filler and binder in tablets, capsules, granules, and pellets.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Lactose Monohydrate
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet, Injectable / Parenteral
Grade : Parenteral, Oral
Brand Name : PIG SKIN GELATIN 100B 20M
Application : Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : Pig skin gelatin 100B 20M is used as a filler and binder in capsules, tablets, pellets, and granules and as a stabilizer in parenteral formulations.
Direct Compression
Disintegrants & Superdisintegrants
Thickeners and Stabilizers
Taste Masking
Chewable & Orodispersible Aids
Granulation
Lubricants & Glidants
Co-Processed Excipients
Empty Capsules
Coating Systems & Additives
Parenteral
Film Formers & Plasticizers
Coloring Agents
Controlled & Modified Release
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
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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).
