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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
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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
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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 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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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
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.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Dosage Form : Tablet
Grade : Oral
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
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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 : 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.
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.
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.
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 also used as a stabilizer in liquid formulations & as a bulking agent in 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.
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
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.
Direct Compression
Disintegrants & Superdisintegrants
Co-Processed Excipients
Taste Masking
Thickeners and Stabilizers
Chewable & Orodispersible Aids
Granulation
Lubricants & Glidants
Empty Capsules
Coating Systems & Additives
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.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX AV01FG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01FG is used as a coloring and coating agent in oral solid dosage forms such as capsules, tablets, granules, and pellets.
Pharmacopoeia Ref : Fami-QS, Kosher, Halal, OHSAS ...
Technical Specs : Ti 59.95% and O 40.05%
Ingredient(s) : Titanium Dioxide
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Brand Name : Titanium dioxide PRETIOX AV01PhG
Application : Coating Systems & Additives, Coloring Agents
Excipient Details : Titanium dioxide Pretiox AV01PhG is used as a coating and coloring agent in oral solids such as tablets, capsules, granules, and pellets.
Parenteral
Film Formers & Plasticizers
Coloring Agents
Controlled & Modified Release
Emulsifying Agents
Rheology Modifiers
API Stability Enhancers
Solubilizers
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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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