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Chemistry

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Also known as: Dl-amphetamine sulfate, Amphetamine sulphate, Phenaminum, 60-13-9, Amphamine sulfate, Amphetamini sulfas
Molecular Formula
C18H28N2O4S
Molecular Weight
368.5  g/mol
InChI Key
PYHRZPFZZDCOPH-UHFFFAOYSA-N
FDA UNII
6DPV8NK46S

Amphetamine Sulfate
Amphetamine Sulfate is the sulfate salt form of amphetamine, a synthetic substance related to natural sympathomimetic amines. Amphetamine appears to exert its central nervous system (CNS) and peripheral effects indirectly by inducing the release of biogenic amines from their storage sites in nerve terminals. This agent is a commonly abused psychostimulant drug, which may be snorted, taken orally, smoked, or injected. Amphetamine induces psychologic dependence which is manifested by elevated mood, increased wakefulness, concentration, physical performance and a feeling of well-being. With sustained use, the effects of tachycardia and enhanced alertness diminish while psychotoxic effects such as hallucinations and delusions may occur. (NCI04)
1 2D Structure

Amphetamine Sulfate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-phenylpropan-2-amine;sulfuric acid
2.1.2 InChI
InChI=1S/2C9H13N.H2O4S/c2*1-8(10)7-9-5-3-2-4-6-9;1-5(2,3)4/h2*2-6,8H,7,10H2,1H3;(H2,1,2,3,4)
2.1.3 InChI Key
PYHRZPFZZDCOPH-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(CC1=CC=CC=C1)N.CC(CC1=CC=CC=C1)N.OS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
6DPV8NK46S
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. Dl-amphetamine Sulfate

2. Amphetamine Sulphate

3. Phenaminum

4. 60-13-9

5. Amphamine Sulfate

6. Amphetamini Sulfas

7. Dl-phenamine Sulfate

8. Dl-amphetamine Sulphate

9. Amphetaminium Sulfuricum

10. Desoxynorephedrine Sulfate

11. (+-)-amphetamine Sulfate

12. Dl-amphetamine Hydrogen Sulfate

13. (+-)-phenisopropylamine Sulfate

14. Amfetamine Sulfate

15. Amphetamine Sulfate [usp]

16. Dl-1-phenyl-2-aminopropane Sulfate

17. (+-)-2-amino-1-phenylpropane Sulfate

18. (+-)-alpha-methylphenethylamine Sulfate (2:1)

19. 6dpv8nk46s

20. 1-phenylpropan-2-amine Sulfate (2:1)

21. Amphetamine Sulfate (usp)

22. Fenopromin Sulfate

23. Penamine (van)

24. Ccris 3644

25. 1-phenyl-2-aminopropane Sulfate

26. Cerm 1767

27. Razemisches Phenylaminopropansulfat

28. Dl-alpha-methylphenethylamine Sulfate

29. Einecs 200-457-8

30. Unii-6dpv8nk46s

31. Nsc 170999

32. Dl-amphetamine Sulfate Salt

33. Benzadrine

34. Alpha-methylphenethylamine Sulfate, (+-)-

35. Benzedrine (tn)

36. Evekeo (tn)

37. Evekeo Odt

38. Rac-amphetamine Sulphate

39. D-amphetamine Sulfate Salt

40. Schembl41204

41. Amphetamine Sulfate [mi]

42. Dtxsid4020082

43. Phenethylamine, Alpha-methyl-, Sulfate (2:1), (+-)-

44. Chebi:51063

45. Amfetamine Sulfate [mart.]

46. Amphetamine Sulfate [vandf]

47. Amfetamine Sulfate [who-dd]

48. Bis{1-phenylpropan-2-amine} Sulfate

49. Amfetamine Sulfate [ep Impurity]

50. Amfetamine Sulfate [ep Monograph]

51. Amphetamine Sulfate [orange Book]

52. .beta.-phenylisopyropylaminesulfate

53. Benzeneethanamine, Alpha-methyl-, Sulfate

54. Amphetamine Sulfate [usp Monograph]

55. Amfetamine Sulfate [incb:green List]

56. Delcobese Component Amphetamine Sulfate

57. D02074

58. (+/-)-2-amino-1-phenylpropane Sulfate

59. (+/-)-2-amino-1-phenylpropane Sulphate

60. Amphetamine Sulfate Component Of Delcobese

61. Q21270844

62. (+/-)-.alpha.-methylphenethylamine Sulfate (2:1)

63. (+/-)-.alpha.-methylphenethylamine Sulphate (2:1)

64. Benzeneethanamine, .alpha.-methyl-, Sulfate (2:1), (+/-)-

65. Benzeneethanamine, .alpha.-methyl-, Sulphate (2:1), (+/-)-

66. Dl-amphetamine Sulfate Salt Solution, Drug Standard, 1.0 Mg/ml In Methanol

67. 2-(tetrahydro-furan-2-yl)-n-(3-trifluoromethyl-phenyl)-succinamicacid

68. 156-31-0

2.3.2 Other Synonyms

1. Amfetamine

2. Mydrial

3. Desoxynorephedrine

4. L Amphetamine

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 368.5 g/mol
Molecular Formula C18H28N2O4S
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count6
Rotatable Bond Count4
Exact Mass368.17697855 g/mol
Monoisotopic Mass368.17697855 g/mol
Topological Polar Surface Area135 Ų
Heavy Atom Count25
Formal Charge0
Complexity166
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count2
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3

API SUPPLIERS

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Listed Suppliers

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01

Veranova

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothVeranova: A CDMO that manages complexity with confidence.

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Amphetamine

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...

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 challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle. Macfarlan Smith Limited is trading as Veranova in the United Kingdom.
Veranova

02

AXYNTIS Group

France
IOPC
Not Confirmed
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AXYNTIS Group

France
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IOPC
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Amphetamine Sulfate

About the Company : Axyntis Group, founded in 2007, is France’s leading independent multi-site player in fine chemicals with a €90 million annual turnover. Axyntis has become a key producer of API...

Axyntis Group, founded in 2007, is France’s leading independent multi-site player in fine chemicals with a €90 million annual turnover. Axyntis has become a key producer of APIs in France through acquisitions & partnerships. It has two divisions (dyes and fine chemicals) and places a strong focus on diversification and innovation. It operates 3 cGMP sites in France, of which 2 are FDA-inspected. It provides CDMO services to its partners for their API or advanced intermediate projects, from early-stage development to the commercial phase, including preparative chromatography (Kyrapharm subsidiary). It also commercializes proprietary APIs.
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03

IOPC
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d-Amphetamine Sulfate

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...

Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years of API development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets. We put all of our energy and experience into being your partner of choice. We create value for customers through manufacturing excellence, reliable quality and innovative science. Our people are the experts that our customers enjoy working with.
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04

IOPC
Not Confirmed
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AMPHETAMINE SULFATE

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...

Driven by passion, our pharmaceutical products, expertise and technologies accelerate our customers’ small molecule therapeutics into markets across the world. With over 35 years of API development and manufacturing expertise, a growing team of more than 1,200 experts and a strong presence in the USA and Europe, we are tried and trusted across branded and generic API markets. We put all of our energy and experience into being your partner of choice. We create value for customers through manufacturing excellence, reliable quality and innovative science. Our people are the experts that our customers enjoy working with.
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05

IOPC
Not Confirmed
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Amphetasul

About the Company : Chr. Olesen Synthesis is a Danish manufacturer of APIs and advanced intermediates. Chr. Olesen Synthesis was established in 2012 after the Chr. Olesen Group acquisition of the mult...

Chr. Olesen Synthesis is a Danish manufacturer of APIs and advanced intermediates. Chr. Olesen Synthesis was established in 2012 after the Chr. Olesen Group acquisition of the multi-purpose synthetic production facility just south of Copenhagen. Chr. Olesen Synthesis is initially active with API’s comprising of molecules like Hydromorphone, Codeine Phosphate, Pramipexole, Terbinafine Risedronate, Tolfenamic Acid, Amphetamine derivatives and advanced intermediates for Buprenorphine and Tamsulosin.
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06

IOPC
Not Confirmed
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Amphetamine phosphate

About the Company : We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to m...

We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to market while improving the lives of their patients across the world. Our objective is to help our customers create a better world as the partner of choice to develop and manufacture complex and challenging substances, highly potent active ingredients, and breaking new ground with innovative vitamin, healthcare, and industrial products.
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07

IOPC
Not Confirmed
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D-Amphetamine Sulfate

About the Company : We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to m...

We have been supporting the pharmaceutical and biopharmaceutical industries with drug development for over 30 years, assisting our clients in developing and bringing new drugs to market while improving the lives of their patients across the world. Our objective is to help our customers create a better world as the partner of choice to develop and manufacture complex and challenging substances, highly potent active ingredients, and breaking new ground with innovative vitamin, healthcare, and industrial products.
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08

IOPC
Not Confirmed
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Amphetamine Sulphate

About the Company : At Embio, technology is the foundation of our success, driving leadership in every product we manufacture. With 30+ years of expertise in bacterial, fungal, and Category 1 GMO biot...

At Embio, technology is the foundation of our success, driving leadership in every product we manufacture. With 30+ years of expertise in bacterial, fungal, and Category 1 GMO biotransformation, we develop fully backward-integrated platforms, creating a first-mover advantage in global markets. A leading manufacturer of Schedule-1 and Schedule-2 substances, Embio excels in controlled substances, intermediates, and chiral molecules. Our US-FDA, PMDA, KFDA, COFEPRIS, and WHO-GMP-approved facility in MIDC Mahad serves 70+ countries, including top 10 pharma companies.
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09

IOPC
Not Confirmed
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Amphetasul

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...

Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.
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10

IOPC
Not Confirmed
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Amphetamine

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...

Mallinckrodt Pharmaceuticals is a multibillion dollar specialty biopharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, steming from nearly 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future. Our strong ability to master and manage complexity is the key component in making high-quality products that provide value for patients.
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API Reference Price

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03-Jan-2022
11-Apr-2025
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INTERMEDIATE SUPPLIERS

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

CAS Number : 25394-33-6

End Use API : Amphetamine Sulfate

About The Company : Malladi Drugs & Pharmaceuticals Ltd was founded in 1980 by microbiologist Mr. M L N Sastry. Within a few years, Malladi established itself as a leader in manufa...

Malladi

02

PMC Isochem

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothPMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.

CAS Number : 3182-95-4

End Use API : Amphetamine Sulfate

About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...

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CAS Number : 103-79-7

End Use API : Amphetamine Sulfate

About The Company : Maisuriya Pharma Solutions is a research-driven & technology-oriented company. Continuous innovations & improvement are the lifeblood of our business. Our major...

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 10MG

USFDA APPLICATION NUMBER - 17078

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 15MG

USFDA APPLICATION NUMBER - 17078

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 5MG

USFDA APPLICATION NUMBER - 17078

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DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - EQ 1.25MG BASE/ML

USFDA APPLICATION NUMBER - 204325

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DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 12.5MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 15.7MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 18.8MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 3.1MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 6.3MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTEN...DOSAGE - TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL - EQ 9.4MG BASE

USFDA APPLICATION NUMBER - 204326

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DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - ...DOSAGE - SUSPENSION, EXTENDED RELEASE;ORAL - 2MG/ML;EQ 0.5MG BASE/ML

USFDA APPLICATION NUMBER - 208147

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 12MG;EQ 3MG BASE

USFDA APPLICATION NUMBER - 210526

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 16MG;EQ 4MG BASE

USFDA APPLICATION NUMBER - 210526

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 4MG;EQ 1MG BASE

USFDA APPLICATION NUMBER - 210526

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 8MG;EQ 2MG BASE

USFDA APPLICATION NUMBER - 210526

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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

USFDA APPLICATION NUMBER - 21303

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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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ABOUT THIS PAGE

Looking for 156-31-0 / Amphetamine API manufacturers, exporters & distributors?

Amphetamine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Amphetamine

Synonyms

Dl-amphetamine sulfate, Amphetamine sulphate, Phenaminum, 60-13-9, Amphamine sulfate, Amphetamini sulfas

Cas Number

156-31-0

Unique Ingredient Identifier (UNII)

6DPV8NK46S

About Amphetamine

Amphetamine Sulfate is the sulfate salt form of amphetamine, a synthetic substance related to natural sympathomimetic amines. Amphetamine appears to exert its central nervous system (CNS) and peripheral effects indirectly by inducing the release of biogenic amines from their storage sites in nerve terminals. This agent is a commonly abused psychostimulant drug, which may be snorted, taken orally, smoked, or injected. Amphetamine induces psychologic dependence which is manifested by elevated mood, increased wakefulness, concentration, physical performance and a feeling of well-being. With sustained use, the effects of tachycardia and enhanced alertness diminish while psychotoxic effects such as hallucinations and delusions may occur. (NCI04)

Dextroamphetamine Sulfate Manufacturers

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

Dextroamphetamine Sulfate Suppliers

A Dextroamphetamine Sulfate supplier is an individual or a company that provides Dextroamphetamine Sulfate active pharmaceutical ingredient (API) or Dextroamphetamine Sulfate finished formulations upon request. The Dextroamphetamine Sulfate suppliers may include Dextroamphetamine Sulfate API manufacturers, exporters, distributors and traders.

click here to find a list of Dextroamphetamine Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Dextroamphetamine Sulfate USDMF

A Dextroamphetamine Sulfate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dextroamphetamine Sulfate active pharmaceutical ingredient (API) in detail. Different forms of Dextroamphetamine Sulfate DMFs exist exist since differing nations have different regulations, such as Dextroamphetamine Sulfate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Dextroamphetamine Sulfate DMF submitted to regulatory agencies in the US is known as a USDMF. Dextroamphetamine Sulfate USDMF includes data on Dextroamphetamine Sulfate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dextroamphetamine Sulfate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Dextroamphetamine Sulfate suppliers with USDMF on PharmaCompass.

Dextroamphetamine Sulfate CEP

A Dextroamphetamine Sulfate CEP of the European Pharmacopoeia monograph is often referred to as a Dextroamphetamine Sulfate Certificate of Suitability (COS). The purpose of a Dextroamphetamine Sulfate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dextroamphetamine Sulfate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dextroamphetamine Sulfate to their clients by showing that a Dextroamphetamine Sulfate CEP has been issued for it. The manufacturer submits a Dextroamphetamine Sulfate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dextroamphetamine Sulfate CEP holder for the record. Additionally, the data presented in the Dextroamphetamine Sulfate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dextroamphetamine Sulfate DMF.

A Dextroamphetamine Sulfate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dextroamphetamine Sulfate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Dextroamphetamine Sulfate suppliers with CEP (COS) on PharmaCompass.

Dextroamphetamine Sulfate 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 Dextroamphetamine Sulfate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Dextroamphetamine Sulfate 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 Dextroamphetamine Sulfate 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 Dextroamphetamine Sulfate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dextroamphetamine Sulfate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Dextroamphetamine Sulfate suppliers with NDC on PharmaCompass.

Dextroamphetamine Sulfate GMP

Dextroamphetamine Sulfate 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 Dextroamphetamine Sulfate 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 Dextroamphetamine Sulfate GMP manufacturer or Dextroamphetamine Sulfate GMP API supplier for your needs.

Dextroamphetamine Sulfate CoA

A Dextroamphetamine Sulfate CoA (Certificate of Analysis) is a formal document that attests to Dextroamphetamine Sulfate's compliance with Dextroamphetamine Sulfate specifications and serves as a tool for batch-level quality control.

Dextroamphetamine Sulfate CoA mostly includes findings from lab analyses of a specific batch. For each Dextroamphetamine Sulfate 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.

Dextroamphetamine Sulfate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dextroamphetamine Sulfate EP), Dextroamphetamine Sulfate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dextroamphetamine Sulfate 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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