Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
US Medicaid
NA
Regulatory FDF Prices
NA
0
FDF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers


1. Schembl1030967
| Molecular Weight | 268.31 g/mol |
|---|---|
| Molecular Formula | C13H20N2O4 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 5 |
| Exact Mass | 268.14230712 g/mol |
| Monoisotopic Mass | 268.14230712 g/mol |
| Topological Polar Surface Area | 127 Ų |
| Heavy Atom Count | 19 |
| Formal Charge | 0 |
| Complexity | 217 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16020
Submission : 2002-06-21
Status : Active
Type : II
NDC Package Code : 65392-0117
Start Marketing Date : 2018-05-02
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-10
Pay. Date : 2013-04-03
DMF Number : 24072
Submission : 2010-08-16
Status : Active
Type : II
NDC Package Code : 49812-0295
Start Marketing Date : 2021-09-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : CA |
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-05-24
Pay. Date : 2015-08-27
DMF Number : 29602
Submission : 2016-02-25
Status : Active
Type : II
NDC Package Code : 0792-3937
Start Marketing Date : 2023-07-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-03
Pay. Date : 2013-11-21
DMF Number : 17692
Submission : 2004-09-22
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-02-26
Pay. Date : 2019-11-07
DMF Number : 34292
Submission : 2020-01-31
Status : Active
Type : II
NDC Package Code : 49812-0061
Start Marketing Date : 1999-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : CA |
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-08
Pay. Date : 2013-05-31
DMF Number : 15435
Submission : 2001-05-15
Status : Active
Type : II
NDC Package Code : 0406-3993
Start Marketing Date : 2013-11-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2024-10-10
Pay. Date : 2024-07-17
DMF Number : 37626
Submission : 2024-06-28
Status : Active
Type : II
NDC Package Code : 61960-0180
Start Marketing Date : 2023-06-23
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-11
Pay. Date : 2012-12-12
DMF Number : 15306
Submission : 2001-02-26
Status : Active
Type : II
NDC Package Code : 59116-1964
Start Marketing Date : 2015-09-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-28
Pay. Date : 2015-09-28
DMF Number : 29810
Submission : 2015-09-16
Status : Active
Type : II
NDC Package Code : 59116-4990
Start Marketing Date : 2015-08-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 59116-1960
Start Marketing Date : 2012-10-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
AMPHETAMINE ASPARTATE MONOHYDRATE
NDC Package Code : 65392-0117
Start Marketing Date : 2018-05-02
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49812-0061
Start Marketing Date : 1999-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
AMPHETAMINE ASPARTATE MONOHYDRATE
NDC Package Code : 49812-0295
Start Marketing Date : 2021-09-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
AMPHETAMINE ASPARTATE MONOHYDRATE
NDC Package Code : 0792-3937
Start Marketing Date : 2023-07-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
AMPHETAMINE ASPARTATE MONOHYDRATE
NDC Package Code : 59116-1960
Start Marketing Date : 2012-10-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

AMPHETAMINE ASPARTATE MONOHYDRATE
NDC Package Code : 59116-1962
Start Marketing Date : 2012-10-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

AMPHETAMINE ASPARTATE MONOHYDRATE
NDC Package Code : 59116-1961
Start Marketing Date : 2012-10-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

AMPHETAMINE ASPARTATE MONOHYDRATE
NDC Package Code : 59116-1964
Start Marketing Date : 2015-09-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

AMPHETAMINE ASPARTATE MONOHYDRATE
NDC Package Code : 59116-1963
Start Marketing Date : 2013-11-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 59116-4990
Start Marketing Date : 2015-08-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
About the Company : Curia is a leading global CDMO with over 30 years of experience supporting clients across drug discovery, development, and commercial manufacturing. Leveraging deep scientific expe...
About the Company : Veranova is a global leader in developing and manufacturing specialist and complex APIs for pharma and biotech customers, with over 50 years of experience supporting the healthcare...
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
About the Company : Siegfried is a global Contract Development and Manufacturing Organization providing integrated services for pharmaceutical ingredients & finished dosage forms. With 13 production s...
About the Company : Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years...

About the Company : Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to addr...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1.25MG;1.25MG;1.25MG;1.25MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1.875MG;1.875MG;1.875MG;1.875MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 2.5MG;2.5MG;2.5MG;2.5MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 3.125MG;3.125MG;3.125MG;3.125MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 3.75MG;3.75MG;3.75MG;3.75MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG;5MG;5MG;5MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 7.5MG;7.5MG;7.5MG;7.5MG
Packaging :
Approval Date : 2021-12-28
Application Number : 215771
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 1.25MG;1.25MG;1.25MG;1.25MG
Packaging :
Approval Date : 2023-01-23
Application Number : 217027
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 2.5MG;2.5MG;2.5MG;2.5MG
Packaging :
Approval Date : 2023-01-23
Application Number : 217027
Regulatory Info : RX
Registration Country : USA
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Regulatory Info : RX
Registration Country : USA
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 3.75MG;3.75MG;3.75MG;3.75MG
Packaging :
Approval Date : 2023-01-23
Application Number : 217027
Regulatory Info : RX
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 1.875MG;1.875MG;1.875MG;1.875MG
Approval Date : 2021-12-28
Application Number : 215771
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 2.5MG;2.5MG;2.5MG;2.5MG
Approval Date : 2021-12-28
Application Number : 215771
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 3.125MG;3.125MG;3.125MG;3.125MG
Approval Date : 2021-12-28
Application Number : 215771
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 3.75MG;3.75MG;3.75MG;3.75MG
Approval Date : 2021-12-28
Application Number : 215771
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG;5MG;5MG;5MG
Approval Date : 2021-12-28
Application Number : 215771
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 7.5MG;7.5MG;7.5MG;7.5MG
Approval Date : 2021-12-28
Application Number : 215771
RX/OTC/DISCN : RX
RLD : No
TE Code : AB
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB1
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 1.25MG;1.25MG;1.25MG;1.25MG
Approval Date : 2023-01-23
Application Number : 217027
RX/OTC/DISCN : RX
RLD : No
TE Code : AB1
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB1
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 2.5MG;2.5MG;2.5MG;2.5MG
Approval Date : 2023-01-23
Application Number : 217027
RX/OTC/DISCN : RX
RLD : No
TE Code : AB1
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB1
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 3.75MG;3.75MG;3.75MG;3.75MG
Approval Date : 2023-01-23
Application Number : 217027
RX/OTC/DISCN : RX
RLD : No
TE Code : AB1
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AB1
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Brand Name : DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 6.25MG;6.25MG;6.25MG;6.25MG
Approval Date : 2023-01-23
Application Number : 217027
RX/OTC/DISCN : RX
RLD : No
TE Code : AB1
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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PharmaCompass offers a list of Amphetamine Aspartate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, 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.
A Amphetamine Aspartate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amphetamine Aspartate, including repackagers and relabelers. The FDA regulates Amphetamine Aspartate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amphetamine Aspartate 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Amphetamine Aspartate supplier is an individual or a company that provides Amphetamine Aspartate active pharmaceutical ingredient (API) or Amphetamine Aspartate finished formulations upon request. The Amphetamine Aspartate suppliers may include Amphetamine Aspartate API manufacturers, exporters, distributors and traders.
click here to find a list of Amphetamine Aspartate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Amphetamine Aspartate DMF (Drug Master File) is a document detailing the whole manufacturing process of Amphetamine Aspartate active pharmaceutical ingredient (API) in detail. Different forms of Amphetamine Aspartate DMFs exist exist since differing nations have different regulations, such as Amphetamine Aspartate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amphetamine Aspartate DMF submitted to regulatory agencies in the US is known as a USDMF. Amphetamine Aspartate USDMF includes data on Amphetamine Aspartate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amphetamine Aspartate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amphetamine Aspartate 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Amphetamine Aspartate 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amphetamine Aspartate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Amphetamine Aspartate suppliers with NDC on PharmaCompass.
Amphetamine Aspartate 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 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Amphetamine Aspartate GMP manufacturer or Amphetamine Aspartate GMP API supplier for your needs.
A Amphetamine Aspartate CoA (Certificate of Analysis) is a formal document that attests to Amphetamine Aspartate's compliance with Amphetamine Aspartate specifications and serves as a tool for batch-level quality control.
Amphetamine Aspartate CoA mostly includes findings from lab analyses of a specific batch. For each Amphetamine Aspartate 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Amphetamine Aspartate EP), Amphetamine Aspartate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amphetamine Aspartate USP).