Synopsis
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NDC API
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FDA Orange Book
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1. 5,6-epoxy-4,22,27-trihydroxy-1-oxoergosta-2,24-dienoic Acid Delta-lactone
1. 5119-48-2
2. Withaferine A
3. Nsc 273757
4. Withaferin Deriv Jpr, Iowa U. Compound
5. Nsc-101088
6. Nsc101088
7. L6do3qw4k5
8. Ashwagandha
9. Chebi:69120
10. Nsc-273757
11. 4beta,27-dihydroxy-1-oxo-5beta,6beta-epoxywitha-2,24-dienolide
12. (1s,2r,6s,7r,9r,11s,12s,15r,16s)-6-hydroxy-15-[(1s)-1-[(2r)-5-(hydroxymethyl)-4-methyl-6-oxo-2,3-dihydropyran-2-yl]ethyl]-2,16-dimethyl-8-oxapentacyclo[9.7.0.02,7.07,9.012,16]octadec-4-en-3-one
13. (6s,7r,9r)-6-hydroxy-15-[(2r,3r)-3-hydroxy-4-(4-methyl-5-oxo-2h-furan-3-yl)butan-2-yl]-2,16-dimethyl-8-oxapentacyclo[9.7.0.02,7.07,9.012,16]octadec-4-en-3-one
14. (4beta,5beta,6beta,22r)-4,27-dihydroxy-5,6:22,26-diepoxyergosta-2,24-diene-1,26-dione
15. Unii-l6do3qw4k5
16. Brn 1335150
17. 5.beta.-ergosta-2, 5,6.beta.-epoxy-4.beta.,22,27-trihydroxy-1-oxo-, .delta.-lactone, (20s,22r)-
18. Ergosta-2, 5,6-epoxy-4,22,27-trihydroxy-1-oxo-, .delta.-lactone, (4.beta.,5.beta.,6.beta.,22r)-
19. Nsc 101088
20. Withaferin A [mi]
21. 5-19-06-00604 (beilstein Handbook Reference)
22. Mls006010687
23. Schembl157208
24. Chembl517080
25. Withaferin A, Analytical Standard
26. Withaferin A, >=95% (hplc)
27. Hy-n2065
28. Zinc8234189
29. Mfcd10687098
30. Nsc273757
31. S8587
32. Ncgc00180796-02
33. (4beta,5beta,6beta,22r)-5,6-epoxy-4,22,27-trihydroxy-1-oxoergosta-2,24-dien-26-oic Acid, Delta-lactone
34. 5-beta-ergosta-2,24-dien-26-oic Acid, 5,6-beta-epoxy-4-beta,22,27-trihydroxy-1-oxo-, Delta-lactone, (20s,22r)-
35. 5beta-ergosta-2,24-dien-26-oic Acid, 5,6beta-epoxy-4beta,22,27-trihydroxy-1-oxo-, Delta-lactone, (20s,22r)-
36. As-77575
37. Ergosta-2,24-dien-26-oic Acid, 5,6-epoxy-4,22,27-trihydroxy-1-oxo-, Gamma-lactone, (4bta,5beta,6beta,22r)-
38. Nci60_000031
39. Smr004701668
40. B7199
41. Cs-0018562
42. Withaferin A 100 Microg/ml In Acetonitrile
43. C08841
44. A871350
45. A1-06845
46. Q6606395
47. Brd-k88378636-001-01-0
48. Withaferin A (constituent Of Ashwagandha Root) [dsc]
49. Wln: T3 F5 E666 1a R Axo Ov Pu Ch&ttttj J1 N1 Rq Iy1&- Ft6ov Cutj C1q D1
50. (4.beta.,5.beta.,6.beta.,22r)-4,27-dihydroxy-5,6:22,26-diepoxyergosta-2,24-diene-1,26-dione
51. Ergosta-2,24-dien-26-oicacid, 5,6-epoxy-4,22,27-trihydroxy-1-oxo-, D-lactone, (4b,5b,6b,22r)-
52. Ncgc00180796-02_c28h38o6_(4beta,5beta,6beta,22r)-4,27-dihydroxy-5,6:22,26-diepoxyergosta-2,24-diene-1,26-dione
| Molecular Weight | 470.6 g/mol |
|---|---|
| Molecular Formula | C28H38O6 |
| XLogP3 | 3.8 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 3 |
| Exact Mass | 470.26683893 g/mol |
| Monoisotopic Mass | 470.26683893 g/mol |
| Topological Polar Surface Area | 96.4 Ų |
| Heavy Atom Count | 34 |
| Formal Charge | 0 |
| Complexity | 999 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 11 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Alkaloids Bioactives: US FDA, TGA & ISO-Certified Pioneers in Plant-Derived APIs, Nutraceuticals & Cosmeceuticals
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34060
Submission : 2019-08-10
Status : Active
Type : II



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Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
About the Company : Octavius Pharma is a global leader in Directly Compressible Granules with over 45 years of expertise in formulation development, manufacturing, and commercialization. Our portfolio...
Alkaloids Bioactives: US FDA, TGA & ISO-Certified Pioneers in Plant-Derived APIs, Nutraceuticals & Cosmeceuticals
About the Company : Alkaloids Bioactives Private Limited is a pioneer in manufacturing plant-derived APIs, Nutraceuticals, and Cosmeceuticals. With a legacy spanning decades (formerly Alkaloids Pvt Lt...
About the Company : The Schwabe Group comprises several different affiliated companies in the pharmaceutical and health industry. All of the companies within the Group focus on plants as the basis for...

About the Company : PK Components is a Polish distributor of raw materials for the production of dietary supplements and for the food industry. Our hallmark is a stable market position, customer trust...

About the Company : Sunpure Extracts Pvt Ltd is a diversified Company, with interests in fields as diverse as Herbal Extracts, Nutraceuticals, Phytochemicals, bio ingredients, spice and natural specia...

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Ashwagandha, a plant extract/herbal product, shows promise in addressing stress.
Lead Product(s): Ashwagandha
Therapeutic Area: Psychiatry/Psychology Brand Name: Ashwa.30
Study Phase: Phase IProduct Type: Plant Extract/Herbal
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 13, 2025

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Lead Product(s) : Ashwagandha
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study Confirms Stress-Reduction Benefits of Ashwa.30 Natural Remedies
Details : Ashwagandha, a plant extract/herbal product, shows promise in addressing stress.
Product Name : Ashwa.30
Product Type : Plant Extract/Herbal
Upfront Cash : Inapplicable
October 13, 2025

Details:
Ashwagandha is a Plant Extract/Herbal drug candidate, which is currently being evaluated in clinical studies for the treatment of Stress Disorders, Traumatic.
Lead Product(s): Ashwagandha,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Plant Extract/Herbal
Sponsor: Agaja Pharma Pvt. Ltd.
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 04, 2024

Lead Product(s) : Ashwagandha,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Agaja Pharma Pvt. Ltd.
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ashwagandha is a Plant Extract/Herbal drug candidate, which is currently being evaluated in clinical studies for the treatment of Stress Disorders, Traumatic.
Product Name : Undisclosed
Product Type : Plant Extract/Herbal
Upfront Cash : Inapplicable
December 04, 2024

Details:
Ashwagandha is a Plant Extract/Herbal drug candidate, which is currently being evaluated in clinical studies for the treatment of Anxiety.
Lead Product(s): Ashwagandha,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Plant Extract/Herbal
Sponsor: Ixoreal Biomed Inc.
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 13, 2023

Lead Product(s) : Ashwagandha,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Ixoreal Biomed Inc.
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Ashwagandha is a Plant Extract/Herbal drug candidate, which is currently being evaluated in clinical studies for the treatment of Anxiety.
Product Name : Undisclosed
Product Type : Plant Extract/Herbal
Upfront Cash : Inapplicable
January 13, 2023

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Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Melatonin; Ashwagandha; Valerian dry extract; Chamomile Extract
Brand Name : Melatonin Effervescent
Dosage Form : Effervescent Tablet
Dosage Strength : 10MG; 25MG; 50MG; 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Octavius Pharma has been empowering lives since 1980 by providing quality products like DC granules, APIs and FDFs.
Regulatory Info :
Registration Country : India
Brand Name : Ashwagandha Effervescent
Dosage Form : Effervescent Tablet
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form :
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
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Dosage Strength : 100MG
Packaging :
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Registration Country : India

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PharmaCompass offers a list of Ashwagandha 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 Ashwagandha manufacturer or Ashwagandha supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ashwagandha manufacturer or Ashwagandha supplier.
PharmaCompass also assists you with knowing the Ashwagandha API Price utilized in the formulation of products. Ashwagandha API Price is not always fixed or binding as the Ashwagandha Price is obtained through a variety of data sources. The Ashwagandha Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ashwagandha manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ashwagandha, including repackagers and relabelers. The FDA regulates Ashwagandha manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ashwagandha 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 Ashwagandha manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ashwagandha supplier is an individual or a company that provides Ashwagandha active pharmaceutical ingredient (API) or Ashwagandha finished formulations upon request. The Ashwagandha suppliers may include Ashwagandha API manufacturers, exporters, distributors and traders.
click here to find a list of Ashwagandha suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ashwagandha DMF (Drug Master File) is a document detailing the whole manufacturing process of Ashwagandha active pharmaceutical ingredient (API) in detail. Different forms of Ashwagandha DMFs exist exist since differing nations have different regulations, such as Ashwagandha USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ashwagandha DMF submitted to regulatory agencies in the US is known as a USDMF. Ashwagandha USDMF includes data on Ashwagandha's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ashwagandha USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ashwagandha suppliers with USDMF on PharmaCompass.
Ashwagandha 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 Ashwagandha 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 Ashwagandha GMP manufacturer or Ashwagandha GMP API supplier for your needs.
A Ashwagandha CoA (Certificate of Analysis) is a formal document that attests to Ashwagandha's compliance with Ashwagandha specifications and serves as a tool for batch-level quality control.
Ashwagandha CoA mostly includes findings from lab analyses of a specific batch. For each Ashwagandha 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.
Ashwagandha may be tested according to a variety of international standards, such as European Pharmacopoeia (Ashwagandha EP), Ashwagandha JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ashwagandha USP).