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 |
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 : 1.25MG;1.25MG;1.25MG;1.25MG
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 : 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 : 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 : 5MG;5MG;5MG;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 : 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
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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 ADDERALL XR 10 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ADDERALL XR 10, including repackagers and relabelers. The FDA regulates ADDERALL XR 10 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ADDERALL XR 10 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 ADDERALL XR 10 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A ADDERALL XR 10 supplier is an individual or a company that provides ADDERALL XR 10 active pharmaceutical ingredient (API) or ADDERALL XR 10 finished formulations upon request. The ADDERALL XR 10 suppliers may include ADDERALL XR 10 API manufacturers, exporters, distributors and traders.
click here to find a list of ADDERALL XR 10 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A ADDERALL XR 10 DMF (Drug Master File) is a document detailing the whole manufacturing process of ADDERALL XR 10 active pharmaceutical ingredient (API) in detail. Different forms of ADDERALL XR 10 DMFs exist exist since differing nations have different regulations, such as ADDERALL XR 10 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ADDERALL XR 10 DMF submitted to regulatory agencies in the US is known as a USDMF. ADDERALL XR 10 USDMF includes data on ADDERALL XR 10's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ADDERALL XR 10 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ADDERALL XR 10 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 ADDERALL XR 10 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ADDERALL XR 10 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 ADDERALL XR 10 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 ADDERALL XR 10 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ADDERALL XR 10 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ADDERALL XR 10 suppliers with NDC on PharmaCompass.
ADDERALL XR 10 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 ADDERALL XR 10 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right ADDERALL XR 10 GMP manufacturer or ADDERALL XR 10 GMP API supplier for your needs.
A ADDERALL XR 10 CoA (Certificate of Analysis) is a formal document that attests to ADDERALL XR 10's compliance with ADDERALL XR 10 specifications and serves as a tool for batch-level quality control.
ADDERALL XR 10 CoA mostly includes findings from lab analyses of a specific batch. For each ADDERALL XR 10 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.
ADDERALL XR 10 may be tested according to a variety of international standards, such as European Pharmacopoeia (ADDERALL XR 10 EP), ADDERALL XR 10 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ADDERALL XR 10 USP).