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Chemistry

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Also known as: Dextroamphetamine saccharate
Molecular Formula
C15H23NO8
Molecular Weight
345.34  g/mol
InChI Key
VHKVKWTWHZUFIA-QRPNPIFTSA-N

Dextroamphetamine Saccharate
Dextroamphetamine Saccharate is the saccharate salt form of the dextro-isomer of amphetamine, a synthetic substance related to natural sympathomimetic amines, with CNS stimulating properties. Dextroamphetamine saccharate acts by facilitating the release of catecholamines, particularly noradrenaline and dopamine, from its storage sites in nerve terminals in the brain, and inhibits their uptake within the mesocorticolimbic system, a major component of the brain reward system, thereby resulting in measurable behavioral changes such as euphoria. As a CNS stimulant, this agent may increase blood pressure and reduce appetite. Similar to other amphetamines, dextroamphetamine has a high potential for abuse, dependence, and addiction if used in large doses over extended periods of time.
1 2D Structure

Dextroamphetamine Saccharate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-1-phenylpropan-2-amine;2,3,4,5-tetrahydroxyhexanedioic acid
2.1.2 InChI
InChI=1S/C9H13N.C6H10O8/c1-8(10)7-9-5-3-2-4-6-9;7-1(3(9)5(11)12)2(8)4(10)6(13)14/h2-6,8H,7,10H2,1H3;1-4,7-10H,(H,11,12)(H,13,14)/t8-;/m0./s1
2.1.3 InChI Key
VHKVKWTWHZUFIA-QRPNPIFTSA-N
2.1.4 Canonical SMILES
CC(CC1=CC=CC=C1)N.C(C(C(C(=O)O)O)O)(C(C(=O)O)O)O
2.1.5 Isomeric SMILES
C[C@@H](CC1=CC=CC=C1)N.C(C(C(C(=O)O)O)O)(C(C(=O)O)O)O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Dextroamphetamine Saccharate

2.3 Create Date
2010-12-22
3 Chemical and Physical Properties
Molecular Weight 345.34 g/mol
Molecular Formula C15H23NO8
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count9
Rotatable Bond Count7
Exact Mass345.14236669 g/mol
Monoisotopic Mass345.14236669 g/mol
Topological Polar Surface Area182 Ų
Heavy Atom Count24
Formal Charge0
Complexity287
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count4
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

USDMF

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Veranova Lp

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Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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DMF Review : Complete

Rev. Date : 2013-04-10

Pay. Date : 2013-04-03

DMF Number : 24071

Submission : 2010-08-10

Status : Active

Type : II

Veranova

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Veranova Lp

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Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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DMF Review : N/A

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DMF Number : 15090

Submission : 2000-10-13

Status : Active

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Veranova

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GDUFA

DMF Review : Complete

Rev. Date : 2013-01-11

Pay. Date : 2012-12-12

DMF Number : 15305

Submission : 2001-02-26

Status : Active

Type : II

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Curia New York Inc

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DMF Review : Complete

Rev. Date : 2014-01-03

Pay. Date : 2013-11-21

DMF Number : 16022

Submission : 2002-06-21

Status : Active

Type : II

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DMF Review : N/A

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DMF Number : 15608

Submission : 2001-09-01

Status : Inactive

Type : II

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Specgx Llc

Ireland
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DMF Review : Complete

Rev. Date : 2013-06-08

Pay. Date : 2013-05-31

DMF Number : 15428

Submission : 2001-05-15

Status : Active

Type : II

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Siegfried Usa Llc

Switzerland

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Siegfried Usa Llc

Switzerland
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Rev. Date : 2016-08-31

Pay. Date : 2015-08-27

DMF Number : 29603

Submission : 2016-02-25

Status : Active

Type : II

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Switzerland

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Siegfried Usa Llc

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DMF Review : Complete

Rev. Date : 2023-11-06

Pay. Date : 2023-08-03

DMF Number : 38543

Submission : 2023-08-01

Status : Active

Type : II

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FDA Orange Book

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01

GRANULES

India
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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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

02

GRANULES

India
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Digital Content Digital Content

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

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GRANULES

India
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Digital Content Digital Content

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

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GRANULES

India
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Digital Content Digital Content

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

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GRANULES

India
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Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

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

06

GRANULES

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

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

07

GRANULES

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

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

08

GRANULES

India
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  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

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

09

GRANULES

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

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

10

GRANULES

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

Flag India
Digital Content Digital Content

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
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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 1.25MG;1.25MG;1.25MG;1.25MG

USFDA APPLICATION NUMBER - 21303

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 2.5MG;2.5MG;2.5MG;2.5MG

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.7...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 3.75MG;3.75MG;3.75MG;3.75MG

USFDA APPLICATION NUMBER - 21303

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG;5MG;5MG;5MG

USFDA APPLICATION NUMBER - 21303

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.2...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 6.25MG;6.25MG;6.25MG;6.25MG

USFDA APPLICATION NUMBER - 21303

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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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Granulation

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SPI Pharma

U.S.A
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Solubilizers

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SPI Pharma

U.S.A
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Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

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Taste Masking

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Chewable & Orodispersible Aids

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SPI Pharma

U.S.A
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Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

03

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MAGHREB PHARMA
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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Oral

Category : Fillers, Diluents & Binders

06

SPI Pharma

U.S.A
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10

SPI Pharma

U.S.A
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Film Formers & Plasticizers

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MAGHREB PHARMA
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Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

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MAGHREB PHARMA
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Lubricants & Glidants

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MAGHREB PHARMA
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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Oral

Category : Lubricants & Glidants

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Co-Processed Excipients

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Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Grade : Oral

Category : Fillers, Diluents & Binders, Taste Masking

02

SPI Pharma

U.S.A
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Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

03

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Cophex
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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Oral

Category : Co-Processed Excipients

04

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Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

Grade : Oral

Category : Co-Processed Excipients, Fillers, Diluents & Binders

Brand Name : Starlose®

Excipient Details : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.

Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...

Technical Specs : NA

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Virtual BoothGangwal Healthcare is powered by innovation, driving health, wellness & healing.

Grade : Oral

Category : Co-Processed Excipients, Fillers, Diluents & Binders

Brand Name : Microlose™

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%

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Topical

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02

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MAGHREB PHARMA
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Actylis

U.S.A
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Empty Capsules

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Parenteral

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Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Grade : Oral

Category : Fillers, Diluents & Binders, Taste Masking

02

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Cophex
Not Confirmed
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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Oral

Category : Fillers, Diluents & Binders

03

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Cophex
Not Confirmed
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Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

04

Pfanstiehl

U.S.A
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Cophex
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Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Grade : Parenteral

Category : Parenteral, Thickeners and Stabilizers

05

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Cophex
Not Confirmed
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Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

Grade : Oral

Category : Co-Processed Excipients

06

Pfanstiehl

U.S.A
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Cophex
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Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

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Cophex
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Virtual BoothNanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Grade : Parenteral

Category : Parenteral

Brand Name : Lactose Monohydrate

Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

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Emulsifying Agents

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DKSH

Switzerland
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Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Grade : Oral

Category : Emulsifying Agents

Brand Name : HDK® N20 PHARMA

Excipient Details : HDK N20 Pharma is used as a pharmaceutical emulsifying agent in tablets, capsules, syrups, and solutions.

Pharmacopoeia Ref : GRAS certificate, GMP

Technical Specs : N/A

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API Stability Enhancers

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Coloring Agents

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DKSH

Switzerland
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Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

Grade : Oral

Category : Coloring Agents

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DKSH

Switzerland
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DKSH

Switzerland
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ABOUT THIS PAGE

Looking for 300666-47-1 / Dextroamphetamine Saccharate API manufacturers, exporters & distributors?

Dextroamphetamine Saccharate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Dextroamphetamine Saccharate 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 Dextroamphetamine Saccharate manufacturer or Dextroamphetamine Saccharate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dextroamphetamine Saccharate manufacturer or Dextroamphetamine Saccharate supplier.

PharmaCompass also assists you with knowing the Dextroamphetamine Saccharate API Price utilized in the formulation of products. Dextroamphetamine Saccharate API Price is not always fixed or binding as the Dextroamphetamine Saccharate Price is obtained through a variety of data sources. The Dextroamphetamine Saccharate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Dextroamphetamine Saccharate

Cas Number

300666-47-1

About Dextroamphetamine Saccharate

Dextroamphetamine Saccharate is the saccharate salt form of the dextro-isomer of amphetamine, a synthetic substance related to natural sympathomimetic amines, with CNS stimulating properties. Dextroamphetamine saccharate acts by facilitating the release of catecholamines, particularly noradrenaline and dopamine, from its storage sites in nerve terminals in the brain, and inhibits their uptake within the mesocorticolimbic system, a major component of the brain reward system, thereby resulting in measurable behavioral changes such as euphoria. As a CNS stimulant, this agent may increase blood pressure and reduce appetite. Similar to other amphetamines, dextroamphetamine has a high potential for abuse, dependence, and addiction if used in large doses over extended periods of time.

AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 Manufacturers

A AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2, including repackagers and relabelers. The FDA regulates AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 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 ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 Suppliers

A AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 supplier is an individual or a company that provides AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 active pharmaceutical ingredient (API) or AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 finished formulations upon request. The AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 suppliers may include AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 API manufacturers, exporters, distributors and traders.

click here to find a list of AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 USDMF

A AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 DMF (Drug Master File) is a document detailing the whole manufacturing process of AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 active pharmaceutical ingredient (API) in detail. Different forms of AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 DMFs exist exist since differing nations have different regulations, such as AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 DMF submitted to regulatory agencies in the US is known as a USDMF. AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 USDMF includes data on AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 suppliers with USDMF on PharmaCompass.

AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 NDC

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 ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 suppliers with NDC on PharmaCompass.

AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 GMP

AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 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 ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 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 ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 GMP manufacturer or AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 GMP API supplier for your needs.

AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 CoA

A AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 CoA (Certificate of Analysis) is a formal document that attests to AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2's compliance with AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 specifications and serves as a tool for batch-level quality control.

AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 CoA mostly includes findings from lab analyses of a specific batch. For each AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 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 ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 may be tested according to a variety of international standards, such as European Pharmacopoeia (AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 EP), AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF-2 USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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