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CEP/COS
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JDMF
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EU WC
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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
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Europe
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Canada
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Australia
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South Africa
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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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Veranova: A CDMO that manages complexity with confidence.
NDC
CA
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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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Drugs in Development
Lead Product(s) : Amphetamine Sulfate,Amphetamine Aspartate,Dextroamphetamine Saccharate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules Pharmaceuticals Inc., Receives ANDA Approval for Amphetamine Mixed Salts ER Capsules
Details : Dextroamphetamine Sulfate is a non-catecholamine sympathomimetic amines with CNS stimulant activity. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extr...
Product Name : Amphetamine-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
January 24, 2023
Lead Product(s) : Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine Sulfate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules Pharmaceuticals Receives ANDA Approval for Amphetamine Mixed Salts (IR Tablets)
Details : FDA approved generic of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, for Attention Deficit Hyperactivity Disorder and Narcolepsy.
Product Name : Adderall-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
December 30, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.25MG;1.25MG;1.25MG;1.25MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5MG;2.5MG;2.5MG;2.5MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.7...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.75MG;3.75MG;3.75MG;3.75MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG;5MG;5MG;5MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.25MG;6.25MG;6.25MG;6.25MG
USFDA APPLICATION NUMBER - 21303
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 7.5MG;7.5MG;7.5MG;7.5MG
USFDA APPLICATION NUMBER - 21303
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ABOUT THIS PAGE
31
PharmaCompass offers a list of Amphetamine Aspartate 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 Amphetamine Aspartate manufacturer or Amphetamine Aspartate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Amphetamine Aspartate manufacturer or Amphetamine Aspartate supplier.
PharmaCompass also assists you with knowing the Amphetamine Aspartate API Price utilized in the formulation of products. Amphetamine Aspartate API Price is not always fixed or binding as the Amphetamine Aspartate Price is obtained through a variety of data sources. The Amphetamine Aspartate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Amphetamine Aspartate Monohydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amphetamine Aspartate Monohydrate, including repackagers and relabelers. The FDA regulates Amphetamine Aspartate Monohydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amphetamine Aspartate Monohydrate 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 Amphetamine Aspartate Monohydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amphetamine Aspartate Monohydrate supplier is an individual or a company that provides Amphetamine Aspartate Monohydrate active pharmaceutical ingredient (API) or Amphetamine Aspartate Monohydrate finished formulations upon request. The Amphetamine Aspartate Monohydrate suppliers may include Amphetamine Aspartate Monohydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Amphetamine Aspartate Monohydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amphetamine Aspartate Monohydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amphetamine Aspartate Monohydrate active pharmaceutical ingredient (API) in detail. Different forms of Amphetamine Aspartate Monohydrate DMFs exist exist since differing nations have different regulations, such as Amphetamine Aspartate Monohydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amphetamine Aspartate Monohydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Amphetamine Aspartate Monohydrate USDMF includes data on Amphetamine Aspartate Monohydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amphetamine Aspartate Monohydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amphetamine Aspartate Monohydrate suppliers with USDMF 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 Amphetamine Aspartate Monohydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amphetamine Aspartate Monohydrate 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 Amphetamine Aspartate Monohydrate 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 Amphetamine Aspartate Monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amphetamine Aspartate Monohydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amphetamine Aspartate Monohydrate suppliers with NDC on PharmaCompass.
Amphetamine Aspartate Monohydrate 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 Amphetamine Aspartate Monohydrate 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 Amphetamine Aspartate Monohydrate GMP manufacturer or Amphetamine Aspartate Monohydrate GMP API supplier for your needs.
A Amphetamine Aspartate Monohydrate CoA (Certificate of Analysis) is a formal document that attests to Amphetamine Aspartate Monohydrate's compliance with Amphetamine Aspartate Monohydrate specifications and serves as a tool for batch-level quality control.
Amphetamine Aspartate Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Amphetamine Aspartate Monohydrate 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.
Amphetamine Aspartate Monohydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Amphetamine Aspartate Monohydrate EP), Amphetamine Aspartate Monohydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amphetamine Aspartate Monohydrate USP).
