Synopsis
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1. Spinosyn-d
1. Spinosad Factor D
2. 131929-63-0
3. A 83543d
4. Chebi:9232
5. 78g4631rtt
6. (1s,2s,5r,7s,9s,10s,14r,15s,19s)-15-[(2r,5s,6r)-5-(dimethylamino)-6-methyloxan-2-yl]oxy-19-ethyl-4,14-dimethyl-7-[(2r,3r,4r,5s,6s)-3,4,5-trimethoxy-6-methyloxan-2-yl]oxy-20-oxatetracyclo[10.10.0.02,10.05,9]docosa-3,11-diene-13,21-dione
7. (2s,3ar,5as,5bs,9s,13s,14r,16as,16bs)-13-{[(2r,5s,6r)-5-(dimethylamino)-6-methyltetrahydro-2h-pyran-2-yl]oxy}-9-ethyl-4,14-dimethyl-7,15-dioxo-2,3,3a,5a,5b,6,7,9,10,11,12,13,14,15,16a,16b-hexadecahydro-1h-as-indaceno[3,2-d]oxacyclododecin-2-yl 6-deoxy-2,3,4-tri-o-methyl-alpha-l-mannopyranoside
8. 1h-as-indaceno3,2-doxacyclododecin-7,15-dione, 2-(6-deoxy-2,3,4-tri-o-methyl-.alpha.-l-mannopyranosyl)oxy-13-(2r,5s,6r)-5-(dimethylamino)tetrahydro-6-methyl-2h-pyran-2-yloxy-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, (2
9. Spinosad Factor D [usan]
10. Unii-78g4631rtt
11. Spinosyn D [mi]
12. Schembl465825
13. Chembl503450
14. Dtxsid3037599
15. Zinc85537011
16. 1h-as-indaceno(3,2-d)oxacyclododecin-7,15-dione, 2-((6-deoxy-2,3,4-tri-o-methyl-alpha-l-mannopyranosyl)oxy)-13-(((2r,5s,6r)-5-(dimethylamino)tetrahydro-6-methyl-2h-pyran-2-yl)oxy)-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimet
17. Xs175291
18. J-006090
19. Q27108325
20. (2r,3as,5ar,5bs,9s,13s,14r,16as,16br)-2-((6-deoxy-2,3,4-tri-o-methyl-alpha-l-mannopyranosyl)oxy)-13-(((2r,5s,6r)-5-(dimethylamino)tetrahydro-6-methyl-2h-pyran-2-yl)oxy)-9-ethyl-4,14-dimethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-1h-as-indaceno(3,2-d)oxacyclododecin-7,15-dione
21. 1h-as-indaceno(3,2-d)oxacyclododecin-7,15-dione, 2-((6-deoxy-2,3,4-tri-o- Methyl-a-l-mannopyranosyl)oxy)-13-(((2r,5s,6r)-5- (dimethylamino)tetrahydro-6-methyl-2h-pyran-2-yl)oxy)-9-ethyl- 2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, (2s,3ar,5as,5bs,9s,13s,14r,16as,16bs)-
22. 1h-as-indaceno(3,2-d)oxacyclododecin-7,15-dione, 2-((6-deoxy-2,3,4-tri-o-methyl-alpha-l-mannopyranosyl)oxy)-13-(((2r,5s,6r)-5-(dimethylamino)tetrahydro-6-methyl-2h-pyran-2-yl)oxy)-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-4,14-dimethyl-, (2s,3ar,5as,5bs,9s,13s,14r,16as,16bs)-
| Molecular Weight | 746.0 g/mol |
|---|---|
| Molecular Formula | C42H67NO10 |
| XLogP3 | 4.8 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 11 |
| Rotatable Bond Count | 9 |
| Exact Mass | 745.47649733 g/mol |
| Monoisotopic Mass | 745.47649733 g/mol |
| Topological Polar Surface Area | 111 Ų |
| Heavy Atom Count | 53 |
| Formal Charge | 0 |
| Complexity | 1330 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 17 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2021-11-15
Pay. Date : 2021-09-16
DMF Number : 36293
Submission : 2021-09-27
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17795
Submission : 2004-09-29
Status : Active
Type : II
VMF Number : 5791
Submission : 2004-01-02
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2024-09-11
Pay. Date : 2024-08-15
DMF Number : 40075
Submission : 2024-07-30
Status : Active
Type : II
NDC Package Code : 53069-1130
Start Marketing Date : 2024-09-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT


VMF Number : 6490
Submission : 2022-11-09
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 62158-0009
Start Marketing Date : 2021-09-23
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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GDUFA
DMF Review : Complete
Rev. Date : 2021-11-15
Pay. Date : 2021-09-16
DMF Number : 36293
Submission : 2021-09-27
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17795
Submission : 2004-09-29
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2024-09-11
Pay. Date : 2024-08-15
DMF Number : 40075
Submission : 2024-07-30
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Details:
Spinosad is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Blepharitis.
Lead Product(s): Spinosyn D,Inapplicable
Therapeutic Area: Ophthalmology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 06, 2024

Lead Product(s) : Spinosyn D,Inapplicable
Therapeutic Area : Ophthalmology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Spinosad is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Blepharitis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 06, 2024

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Details:
Spinosad is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Scabies.
Lead Product(s): Spinosyn D,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Concentrics Research | IQVIA | Medpace, Inc | Inotiv | BioAgilytix
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 05, 2022

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Lead Product(s) : Spinosyn D,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Concentrics Research | IQVIA | Medpace, Inc | Inotiv | BioAgilytix
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Spinosad is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Scabies.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 05, 2022

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Details:
Natroba (Spinosad) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Scabies.
Lead Product(s): Spinosyn D,Inapplicable
Therapeutic Area: Dermatology Brand Name: Natroba
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Concentrics Research
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 30, 2015

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Lead Product(s) : Spinosyn D,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Concentrics Research
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
Details : Natroba (Spinosad) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Scabies.
Product Name : Natroba
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 30, 2015

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Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Natroba (Spinosad) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Scabies.
Lead Product(s): Spinosyn D,Inapplicable
Therapeutic Area: Dermatology Brand Name: Natroba
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Concentrics Research
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 30, 2015

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Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Spinosyn D,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Concentrics Research
Deal Size : Inapplicable
Deal Type : Inapplicable
Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies
Details : Natroba (Spinosad) is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Scabies.
Product Name : Natroba
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 30, 2015

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Details:
Spinosad is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Lice Infestations.
Lead Product(s): Spinosyn D,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 08, 2012

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Lead Product(s) : Spinosyn D,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Spinosad is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Lice Infestations.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 08, 2012

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
69
PharmaCompass offers a list of Spinosyn D API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Spinosyn D manufacturer or Spinosyn D supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Spinosyn D manufacturer or Spinosyn D supplier.
A Spinosyn D manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spinosyn D, including repackagers and relabelers. The FDA regulates Spinosyn D manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spinosyn D 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 Spinosyn D manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Spinosyn D supplier is an individual or a company that provides Spinosyn D active pharmaceutical ingredient (API) or Spinosyn D finished formulations upon request. The Spinosyn D suppliers may include Spinosyn D API manufacturers, exporters, distributors and traders.
click here to find a list of Spinosyn D suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Spinosyn D DMF (Drug Master File) is a document detailing the whole manufacturing process of Spinosyn D active pharmaceutical ingredient (API) in detail. Different forms of Spinosyn D DMFs exist exist since differing nations have different regulations, such as Spinosyn D USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Spinosyn D DMF submitted to regulatory agencies in the US is known as a USDMF. Spinosyn D USDMF includes data on Spinosyn D's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Spinosyn D USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Spinosyn D suppliers with USDMF on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Spinosyn D as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Spinosyn D 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 Spinosyn D 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 Spinosyn D and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Spinosyn D NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Spinosyn D suppliers with NDC on PharmaCompass.
Spinosyn D 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 Spinosyn D GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Spinosyn D GMP manufacturer or Spinosyn D GMP API supplier for your needs.
A Spinosyn D CoA (Certificate of Analysis) is a formal document that attests to Spinosyn D's compliance with Spinosyn D specifications and serves as a tool for batch-level quality control.
Spinosyn D CoA mostly includes findings from lab analyses of a specific batch. For each Spinosyn D 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.
Spinosyn D may be tested according to a variety of international standards, such as European Pharmacopoeia (Spinosyn D EP), Spinosyn D JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Spinosyn D USP).