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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
1. Amfetamine
2. Mydrial
3. Desoxynorephedrine
4. L Amphetamine
| Molecular Weight | 368.5 g/mol |
|---|---|
| Molecular Formula | C18H28N2O4S |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 4 |
| Exact Mass | 368.17697855 g/mol |
| Monoisotopic Mass | 368.17697855 g/mol |
| Topological Polar Surface Area | 135 Ų |
| Heavy Atom Count | 25 |
| Formal Charge | 0 |
| Complexity | 166 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 2 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Details:
Amphetamine Sulfate, a controlled substance targeting Norepinephrine and Dopamine transporters, shows promise in treating Attention Deficit Hyperactivity Disorder (ADHD).
Lead Product(s): Amphetamine Sulfate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Dyanavel-Generic
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 08, 2026
Lead Product(s) : Amphetamine Sulfate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules India Receives USFDA Tentative Nod for Generic ADHD Tablets
Details : Amphetamine Sulfate, a controlled substance targeting Norepinephrine and Dopamine transporters, shows promise in treating Attention Deficit Hyperactivity Disorder (ADHD).
Product Name : Dyanavel-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
January 08, 2026
Details:
Amphetamine Sulfate, a small molecule product targeting Norepinephrine and Dopamine transporters, shows promise in treating Attention Deficit Hyperactivity Disorder.
Lead Product(s): Amphetamine Sulfate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Adzenys XR-ODT-Generic
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 22, 2025
Lead Product(s) : Amphetamine Sulfate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules Pharma Gets USFDA Tentative Approval for Amphetamine ER ODT ANDA
Details : Amphetamine Sulfate, a small molecule product targeting Norepinephrine and Dopamine transporters, shows promise in treating Attention Deficit Hyperactivity Disorder.
Product Name : Adzenys XR-ODT-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
December 22, 2025
Details:
Dextroamphetamine Sulfate is a non-catecholamine sympathomimetic amines with CNS stimulant activity. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.
Lead Product(s): Amphetamine Sulfate,Amphetamine Aspartate,Dextroamphetamine Saccharate
Therapeutic Area: Psychiatry/Psychology Brand Name: Amphetamine-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 24, 2023
Lead Product(s) : Amphetamine Sulfate,Amphetamine Aspartate,Dextroamphetamine Saccharate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules Pharmaceuticals Inc., Receives ANDA Approval for Amphetamine Mixed Salts ER Capsules
Details : Dextroamphetamine Sulfate is a non-catecholamine sympathomimetic amines with CNS stimulant activity. It is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extr...
Product Name : Amphetamine-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 24, 2023
Details:
FDA approved generic of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, for Attention Deficit Hyperactivity Disorder and Narcolepsy.
Lead Product(s): Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine Sulfate
Therapeutic Area: Psychiatry/Psychology Brand Name: Adderall-Generic
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 30, 2021
Lead Product(s) : Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine Sulfate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Granules Pharmaceuticals Receives ANDA Approval for Amphetamine Mixed Salts (IR Tablets)
Details : FDA approved generic of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, for Attention Deficit Hyperactivity Disorder and Narcolepsy.
Product Name : Adderall-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
December 30, 2021
Details:
Methylphenidate HCl is a controlled substance drug, which is currently being evaluated in Phase IV clinical studies for the treatment of attention deficit disorder with hyperactivity.
Lead Product(s): Methylphenidate Hydrochloride,Amphetamine Sulfate
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Controlled Substance
Sponsor: Tris Pharma Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 16, 2026

Lead Product(s) : Methylphenidate Hydrochloride,Amphetamine Sulfate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Tris Pharma Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
EEG Biomarkers for ADHD Stimulant Treatment
Details : Methylphenidate HCl is a controlled substance drug, which is currently being evaluated in Phase IV clinical studies for the treatment of attention deficit disorder with hyperactivity.
Product Name : Undisclosed
Product Type : Controlled Substance
Upfront Cash : Inapplicable
June 16, 2026

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Details:
Amphetamine Sulfate, a miscellaneous product targeting Norepinephrine transporter and Dopamine transporter, shows promise in treating attention deficit hyperactivity disorder (ADHD).
Lead Product(s): Amphetamine Sulfate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Dyanavel
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 08, 2026

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Lead Product(s) : Amphetamine Sulfate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Kye Pharmaceuticals Launches Dyanavel® XR Tablets for ADHD in Canada
Details : Amphetamine Sulfate, a miscellaneous product targeting Norepinephrine transporter and Dopamine transporter, shows promise in treating attention deficit hyperactivity disorder (ADHD).
Product Name : Dyanavel
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 08, 2026

Details:
Amphetamine Sulfate is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.
Lead Product(s): Amphetamine Sulfate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Premier Research Group
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 11, 2025

Lead Product(s) : Amphetamine Sulfate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Premier Research Group
Deal Size : Inapplicable
Deal Type : Inapplicable
ADZENYS XR-ODT™ in Children (4 to <6 Years) Diagnosed With Attention-deficit/Hyperactivity Disor...
Details : Amphetamine Sulfate is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Attention Deficit Disorder with Hyperactivity.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 11, 2025

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Details:
Through the acquisition of Amphetamine Sulfate, a controlled substance targeting Norepinephrine transporter and Dopamine transporter, the deal aims to advance neuroscience research.
Lead Product(s): Amphetamine Sulfate,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Evekeo-Generic
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Aurobindo Pharma Limited
Deal Size: $250.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition July 31, 2025

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Lead Product(s) : Amphetamine Sulfate,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Aurobindo Pharma Limited
Deal Size : $250.0 million
Deal Type : Acquisition
Aurobindo to Acquire Lannett for Rs. 2,185 Cr
Details : Through the acquisition of Amphetamine Sulfate, a controlled substance targeting Norepinephrine transporter and Dopamine transporter, the deal aims to advance neuroscience research.
Product Name : Evekeo-Generic
Product Type : Controlled Substance
Upfront Cash : Undisclosed
July 31, 2025

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Details:
Adderall-Generic is a CNS stimulant, which is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and Narcolepsy.
Lead Product(s): Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine Sulfate,Dextroamphetamine Sulphate
Therapeutic Area: Psychiatry/Psychology Brand Name: Adderall-Generic
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 17, 2025

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Lead Product(s) : Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine Sulfate,Dextroamphetamine Sulphate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Glenmark to Launch Generic Version of Adderall Tablets in the US Market by May 2025
Details : Adderall-Generic is a CNS stimulant, which is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and Narcolepsy.
Product Name : Adderall-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
April 17, 2025

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Adderall XR-Generic is a combination product of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate & amphetamine sulfate. It is indicated for ADHD.
Lead Product(s): Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine Sulfate
Therapeutic Area: Psychiatry/Psychology Brand Name: Adderall XR-Generic
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 21, 2024

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Lead Product(s) : Dextroamphetamine Saccharate,Amphetamine Aspartate,Amphetamine Sulfate
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Lupin Receives FDA Approval for Generic Version of Adderall XR
Details : Adderall XR-Generic is a combination product of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate & amphetamine sulfate. It is indicated for ADHD.
Product Name : Adderall XR-Generic
Product Type : Controlled Substance
Upfront Cash : Inapplicable
November 21, 2024

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]dl-1-Chloro-1-phenyl-2-aminopropane Hydrochloride
CAS Number : 25394-33-6
End Use API : Amphetamine Sulfate
About The Company : Malladi Drugs & Pharmaceuticals Ltd, founded in 1980 by Mr. M L N Sastry, is a leader in manufacturing ephedrine and pseudoephedrine salts. It is now the top AP...
CAS Number : 3182-95-4
End Use API : Amphetamine Sulfate
About The Company : PMC Isochem, acquired by PMC International in 2017, is a CDMO manufacturing cGMP intermediates, APIs, and functional excipients for global pharmaceutical and pe...
Phenyl Acetone OR 1-Phenyl-2-Peopanone
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...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code :
Brand Name : AMPHETAMINE SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date : 2020-07-14
Application Number : 213898
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
RLD : No
TE Code :
Brand Name : AMPHETAMINE SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2020-07-14
Application Number : 213898
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : DEXTROAMPHETAMINE SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 5MG
Approval Date : 1999-05-13
Application Number : 40299
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : DEXTROAMPHETAMINE SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 5MG
Approval Date : 2019-06-21
Application Number : 205077
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : DEXTROAMPHETAMINE SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Approval Date : 2019-06-21
Application Number : 205077
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : DEXTROAMPHETAMINE SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 15MG
Approval Date : 2019-06-21
Application Number : 205077
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : DEXTROAMPHETAMINE SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 5MG
Approval Date : 2017-10-31
Application Number : 205673
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : DEXTROAMPHETAMINE SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 10MG
Approval Date : 2017-10-31
Application Number : 205673
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : DEXTROAMPHETAMINE SULFATE
Dosage Form : CAPSULE, EXTENDED RELEASE;ORAL
Dosage Strength : 15MG
Approval Date : 2017-10-31
Application Number : 205673
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
RLD : No
TE Code : AA
Brand Name : AMPHETAMINE SULFATE
Dosage Form : TABLET;ORAL
Dosage Strength : 10MG
Approval Date : 2019-08-05
Application Number : 212619
RX/OTC/DISCN : RX
RLD : No
TE Code : AA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Application : Fillers, Diluents & Binders, Taste Masking
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
Dosage Form : Cream / Lotion / Ointment, Emulsion, Gel, Solution, Tablet
Grade : Topical, Oral
Category : API Stability Enhancers, Emulsifying Agents, Fillers, Diluents & Binders
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Category : Fillers, Diluents & Binders, Granulation, Solubilizers
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Dosage Form : Injectable / Parenteral, Tablet
Grade : Parenteral, Oral
Category : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers
Excipient Details : D-Mannitol protects proteins from denaturation & degradation. It is used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Mannitol
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking
Grade : Oral
Category : Co-Processed Excipients, Fillers, Diluents & Binders
Application : Co-Processed Excipients, Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF,BP,EP,IP
Technical Specs : NA
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Controlled & Modified Release, Solubilizers
Excipient Details : EUDRAGIT® L 100 (powder), a delayed release polymer is used to increase solubility of poorly soluble products such as tablets, capsules, ODTs, etc.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid Methyl Methacrylate Copolymer
Dosage Form : Cream / Lotion / Ointment, Suspension
Grade : Topical
Category : API Stability Enhancers, Thickeners and Stabilizers
Dosage Form : Tablet
Grade : Oral
Category : Coating Systems & Additives, Controlled & Modified Release
Application : Coating Systems & Additives, Controlled & Modified Release
Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.
Pharmacopoeia Ref : NA
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Dosage Form : Cream / Lotion / Ointment, Capsule, Gel, Tablet
Grade : Oral, Topical
Category : API Stability Enhancers, Thickeners and Stabilizers
Dosage Form : Cream / Lotion / Ointment, Gel, Injectable / Parenteral, Softgel Capsule, Softgels
Grade : Parenteral, Topical, Oral
Category : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Brand Name : Polyethylene Glycol 400
Application : Fillers, Diluents & Binders, Film Formers & Plasticizers, Parenteral, Surfactant & Foaming Agents, Thickeners and Stabilizers, Topical
Excipient Details : PEG 400 is used as a suspending agent, stabilizer, plasticizer and filler in OSDs, liquids & semi-solids and as a solvent for parenteral formulations.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Coating Systems & Additives, Controlled & Modified Release, Solubilizers
Brand Name : EUDRAGIT® L 100-55
Application : Coating Systems & Additives, Controlled & Modified Release, Solubilizers
Excipient Details : EUDRAGIT® L 100-55 (powder) is used in delayed release coatings to enhance solubility of poorly soluble drugs such as tablets, capsules & granules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Brand Name : EUDRAGIT® RS 12,5
Application : Controlled & Modified Release
Excipient Details : EUDRAGIT® RS 12,5 (Organic solution) is a sustained release polymer for customized release profiles used in combination with EUDRAGIT® RL.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Ethyl Acrylate and Methyl Methacrylate Copolymer
Dosage Form : Capsule, Tablet, Topical Film, Transdermal Patch
Grade : Not Available
Category : Controlled & Modified Release, Direct Compression, Granulation
Application : Controlled & Modified Release, Direct Compression, Granulation
Excipient Details : For non-erodible matrices using direct compression, Controlled release matrix. Matrix former in transdermal patches and topical films.
Pharmacopoeia Ref : Ph. Eur., USP-NF, JP-JPE: 80 %...
Technical Specs : Not Available
Ingredient(s) : Lauryl Sulfate
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A Betaphen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Betaphen, including repackagers and relabelers. The FDA regulates Betaphen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Betaphen 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 Betaphen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Betaphen supplier is an individual or a company that provides Betaphen active pharmaceutical ingredient (API) or Betaphen finished formulations upon request. The Betaphen suppliers may include Betaphen API manufacturers, exporters, distributors and traders.
click here to find a list of Betaphen suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Betaphen DMF (Drug Master File) is a document detailing the whole manufacturing process of Betaphen active pharmaceutical ingredient (API) in detail. Different forms of Betaphen DMFs exist exist since differing nations have different regulations, such as Betaphen USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Betaphen DMF submitted to regulatory agencies in the US is known as a USDMF. Betaphen USDMF includes data on Betaphen's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Betaphen USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Betaphen suppliers with USDMF on PharmaCompass.
A Betaphen CEP of the European Pharmacopoeia monograph is often referred to as a Betaphen Certificate of Suitability (COS). The purpose of a Betaphen CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Betaphen EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Betaphen to their clients by showing that a Betaphen CEP has been issued for it. The manufacturer submits a Betaphen CEP (COS) as part of the market authorization procedure, and it takes on the role of a Betaphen CEP holder for the record. Additionally, the data presented in the Betaphen CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Betaphen DMF.
A Betaphen CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Betaphen 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 Betaphen suppliers with CEP (COS) 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 Betaphen as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Betaphen 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 Betaphen 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 Betaphen and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Betaphen NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Betaphen suppliers with NDC on PharmaCompass.
Betaphen 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 Betaphen GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Betaphen GMP manufacturer or Betaphen GMP API supplier for your needs.
A Betaphen CoA (Certificate of Analysis) is a formal document that attests to Betaphen's compliance with Betaphen specifications and serves as a tool for batch-level quality control.
Betaphen CoA mostly includes findings from lab analyses of a specific batch. For each Betaphen 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.
Betaphen may be tested according to a variety of international standards, such as European Pharmacopoeia (Betaphen EP), Betaphen JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Betaphen USP).