Synopsis
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EDQM
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USP
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JP
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Weekly News Recap #Phispers
1. 2-isopropyl-5-(2-phenylethenyl)benzene-1,3-diol
2. 3,5-dh4is
3. 5-(2-phenylethenyl)-2-isopropyl-1,3-benzenediol
4. Benvitimod
5. Gsk2894512
6. Tapinarof
7. Wbi-1001
1. Benvitimod
2. Tapinarof
3. 79338-84-4
4. Wbi-1001
5. Gsk2894512
6. Vtama
7. Wbi 1001
8. Tapinarof [usan]
9. 3,5-dihydroxy-4-isopropyl-trans-stilbene
10. (e)-2-(1-methylethyl)-5-(2-phenylethenyl)-1,3-benzenediol
11. 2-isopropyl-5-styrylbenzene-1,3-diol
12. Gsk-2894512
13. 5-[(e)-2-phenylethenyl]-2-propan-2-ylbenzene-1,3-diol
14. (e)-2-isopropyl-5-styrylbenzene-1,3-diol
15. 84hw7d0v04
16. Tapinarof (usan)
17. 1,3-benzenediol, 2-(1-methylethyl)-5-[(1e)-2-phenylethenyl]-
18. 115781-08-3
19. 1,3-benzenediol, 2-(1-methylethyl)-5-(2-phenylethenyl)-, (e)-
20. 3,5-dh4is
21. Unii-84hw7d0v04
22. 1,3-benzenediol, 2-(1-methylethyl)-5-((1e)-2-phenylethenyl)-
23. Benvitimod (tapinarof)
24. Tapinarof [inn]
25. Tapinarof [who-dd]
26. Schembl918343
27. Chembl259571
28. Gtpl9686
29. Dtxsid301045262
30. Bcp13569
31. Ex-a4877
32. Zinc5761533
33. (e)-4-isopropylstilbene-3,5-diol
34. Mfcd13193203
35. S9700
36. Akos025296109
37. Db06083
38. Wb-1001
39. Ac-36567
40. As-44364
41. Hy-109044
42. Cs-0031487
43. D11365
44. A914284
45. Q4634086
46. 2-(1-methylethyl)-5-[(e)-2-phenylethenyl]benzene-1,3-diol
47. 2-(1-methylethyl)-5-((1e)-2-phenylethenyl)-1,3-benzenediol
48. 5-((1e)-2-phenylethen-1-yl)-2-(propan-2-yl)benzene-1,3-diol
Molecular Weight | 254.32 g/mol |
---|---|
Molecular Formula | C17H18O2 |
XLogP3 | 4.6 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 2 |
Rotatable Bond Count | 3 |
Exact Mass | 254.130679813 g/mol |
Monoisotopic Mass | 254.130679813 g/mol |
Topological Polar Surface Area | 40.5 Ų |
Heavy Atom Count | 19 |
Formal Charge | 0 |
Complexity | 280 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Investigated for use/treatment in psoriasis and psoriatic disorders.
WBI-1001 selectively modulates the cytokine cascade deep under the skin, a process that rapidly decreases inflammations and skin plague. It targets the four major mechanisms involved in the disease.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41643
Submission : 2025-03-31
Status : Active
Type : II
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4104
Start Marketing Date : 2023-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40261
Submission : 2024-07-31
Status : Active
Type : II
NDC Package Code : 70600-058
Start Marketing Date : 2024-07-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : BR |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40623
Submission : 2024-11-28
Status : Active
Type : II
NDC Package Code : 50379-0026
Start Marketing Date : 2023-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41285
Submission : 2025-03-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41061
Submission : 2025-02-05
Status : Active
Type : II
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41643
Submission : 2025-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40261
Submission : 2024-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40623
Submission : 2024-11-28
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41285
Submission : 2025-03-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41061
Submission : 2025-02-05
Status : Active
Type : II
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
NDC Package Code : 64552-4104
Start Marketing Date : 2023-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 70600-058
Start Marketing Date : 2024-07-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 50379-0026
Start Marketing Date : 2023-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
About the Company : Established in 1984, Neuland Laboratories Limited is a publicly listed company headquartered in Hyderabad, India. The company provides solutions across the entire spectrum of the p...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
Interquim comes from an international group of 50 companies active in the pharma, hospital, diagnostics, fine chemicals & feed sectors.
About the Company : Interquim, founded in 1978, is now part of the Ferrer HealthTech division. Interquim specializes in the development of competitive processes for manufacturing high added-value APIs...
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
About the Company : Since its inception in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. With a strong focus on customer support, Seqens assists ...
About the Company : HRV Pharma is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Maithri Drugs Pvt. Ltd. is a trusted global partner in Active Pharmaceutical Ingredients (APIs), supplying to pharmaceutical leaders in 60+ countries. With APIs spanning antivirals...
About the Company : Sekhmet Pharmaventures Pvt. Ltd., an Indian subsidiary of Gamot API Pte. Ltd., is backed by prominent private equity firms including PAG, CX Partners, and Samara Capital. The compa...
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Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
The two companies would strengthen its domestic business by strengthening sales and marketing channels in dermatology including Vtama (tapinarof), paediatrics, and otolaryngology.
Lead Product(s): Tapinarof,Inapplicable
Therapeutic Area: Dermatology Brand Name: Vtama
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Shionogi
Deal Size: $1,050.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition May 07, 2025
Lead Product(s) : Tapinarof,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Shionogi
Deal Size : $1,050.0 million
Deal Type : Acquisition
Shionogi to buy Japan Tobacco's Unit Torii Pharmaceutical for $1 billion
Details : The two companies would strengthen its domestic business by strengthening sales and marketing channels in dermatology including Vtama (tapinarof), paediatrics, and otolaryngology.
Product Name : Vtama
Product Type : Miscellaneous
Upfront Cash : Undisclosed
May 07, 2025
Details:
Tapinarof is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Psoriasis.
Lead Product(s): Tapinarof,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Teva Pharmaceutical Industries
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 19, 2024
Lead Product(s) : Tapinarof,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Teva Pharmaceutical Industries
Deal Size : Inapplicable
Deal Type : Inapplicable
Study Comparing Tapinarof Cream 1% to VTAMA ® (Tapinarof Cream 1%) in the Treatment of Plaque P...
Details : Tapinarof is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Psoriasis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 19, 2024
Details:
Vtama (tapinarof) cream is an aryl hydrocarbon receptor agonist steroid-free, topical cream, for the treatment of atopic dermatitis in adults & children 2 years of age & above.
Lead Product(s): Tapinarof,Inapplicable
Therapeutic Area: Dermatology Brand Name: Vtama
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 16, 2024
Lead Product(s) : Tapinarof,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves VTAMA® Cream for Adults and Kids Aged 2+ with Atopic Dermatitis
Details : Vtama (tapinarof) cream is an aryl hydrocarbon receptor agonist steroid-free, topical cream, for the treatment of atopic dermatitis in adults & children 2 years of age & above.
Product Name : Vtama
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 16, 2024
Details:
Vtama (tapinarof) cream is an aryl hydrocarbon receptor agonist steroid-free, topical cream, for the treatment of atopic dermatitis in adults & children 2 years of age & above.
Lead Product(s): Tapinarof,Inapplicable
Therapeutic Area: Dermatology Brand Name: Vtama
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 05, 2024
Lead Product(s) : Tapinarof,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
VTAMA® Update on FDA Review for Atopic Dermatitis Treatment
Details : Vtama (tapinarof) cream is an aryl hydrocarbon receptor agonist steroid-free, topical cream, for the treatment of atopic dermatitis in adults & children 2 years of age & above.
Product Name : Vtama
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 05, 2024
Details:
Through the acquisition, Organon will leverage the Dermavant pipeline, which includes Vtama (tapinarof) cream. It is indicated for the treatment of f plaque psoriasis in adults.
Lead Product(s): Tapinarof,Inapplicable
Therapeutic Area: Dermatology Brand Name: Vtama
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Organon
Deal Size: $1,200.0 million Upfront Cash: $175.0 million
Deal Type: Acquisition October 28, 2024
Lead Product(s) : Tapinarof,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Organon
Deal Size : $1,200.0 million
Deal Type : Acquisition
Organon Acquires Dermavant's VTAMA® Cream for Dermatology
Details : Through the acquisition, Organon will leverage the Dermavant pipeline, which includes Vtama (tapinarof) cream. It is indicated for the treatment of f plaque psoriasis in adults.
Product Name : Vtama
Product Type : Miscellaneous
Upfront Cash : $175.0 million
October 28, 2024
Details:
Through the acquisition, Organon will leverage the Dermavant pipeline, which includes Vtama (tapinarof) cream. It is indicated for the treatment of f plaque psoriasis in adults.
Lead Product(s): Tapinarof,Inapplicable
Therapeutic Area: Dermatology Brand Name: Vtama
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Organon
Deal Size: $1,200.0 million Upfront Cash: $175.0 million
Deal Type: Acquisition September 18, 2024
Lead Product(s) : Tapinarof,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Organon
Deal Size : $1,200.0 million
Deal Type : Acquisition
Organon Pays up to $1.2B to Acquire Dermavant and its Steroid-Free Skin Cream Vtama
Details : Through the acquisition, Organon will leverage the Dermavant pipeline, which includes Vtama (tapinarof) cream. It is indicated for the treatment of f plaque psoriasis in adults.
Product Name : Vtama
Product Type : Miscellaneous
Upfront Cash : $175.0 million
September 18, 2024
Details:
Tapinarof is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Keratoderma, Palmoplantar.
Lead Product(s): Tapinarof,Inapplicable
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Dermavant Sciences
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 20, 2024
Lead Product(s) : Tapinarof,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Dermavant Sciences
Deal Size : Inapplicable
Deal Type : Inapplicable
Study to Evaluate the Safety and Efficacy of Tapinarof in Adults With Palmoplantar Keratoderma
Details : Tapinarof is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Keratoderma, Palmoplantar.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 20, 2024
Details:
Vtama (tapinarof) cream is an aryl hydrocarbon receptor agonist steroid-free, topical cream, for the treatment of psoriasis in adults and atopic dermatitis in adults & children 2 years of age & above.
Lead Product(s): Tapinarof,Inapplicable
Therapeutic Area: Dermatology Brand Name: Vtama
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Japan Tobacco Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 25, 2024
Lead Product(s) : Tapinarof,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Japan Tobacco Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Dermavant Announces Approval of Tapinarof in both Psoriasis and Atopic Dermatitis in Japan
Details : Vtama (tapinarof) cream is an aryl hydrocarbon receptor agonist steroid-free, topical cream, for the treatment of psoriasis in adults and atopic dermatitis in adults & children 2 years of age & above.
Product Name : Vtama
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 25, 2024
Details:
Vtama (tapinarof) cream is a novel aryl hydrocarbon receptor agonist for once-daily topical treatment of atopic dermatitis in patients 2 years and older.
Lead Product(s): Tapinarof,Inapplicable
Therapeutic Area: Dermatology Brand Name: Vtama
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 29, 2024
Lead Product(s) : Tapinarof,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Dermavant Announces FDA Acceptance Of sNDA for VTAMA® Cream
Details : Vtama (tapinarof) cream is a novel aryl hydrocarbon receptor agonist for once-daily topical treatment of atopic dermatitis in patients 2 years and older.
Product Name : Vtama
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 29, 2024
Details:
Vtama (tapinarof) cream is a novel aryl hydrocarbon receptor agonist, developed as a once-daily, steroid-free topical cream for atopic dermatitis in adults and children 2 years and older.
Lead Product(s): Tapinarof,Inapplicable
Therapeutic Area: Dermatology Brand Name: Vtama
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 14, 2024
Lead Product(s) : Tapinarof,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Dermavant Submits sNDA for VTAMA® Cream, 1% for Atopic Dermatitis
Details : Vtama (tapinarof) cream is a novel aryl hydrocarbon receptor agonist, developed as a once-daily, steroid-free topical cream for atopic dermatitis in adults and children 2 years and older.
Product Name : Vtama
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 14, 2024
07 Jul 2025
// BUSINESSWIRE
https://www.businesswire.com/news/home/20250707974353/en/Organons-VTAMA-tapinarof-cream-1-Granted-Strong-Recommendation-in-the-American-Academy-of-Dermatology-Updated-2025-Guidelines-for-Adult-Atopic-Dermatitis
11 Apr 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/04/11/3060074/0/en/Conduit-Pharmaceuticals-Announces-Novel-Cocrystal-Patent-Filing-For-VTAMA-tapinarof-with-Enhanced-Therapeutic-and-Market-Extension-Prospects.html
04 Apr 2025
// HEALTH CANADA
09 Mar 2025
// BUSINESSWIRE
18 Dec 2024
// BUSINESSWIRE
05 Nov 2024
// BUSINESSWIRE
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Patents & EXCLUSIVITIES
Patent Expiration Date : 2039-11-13
US Patent Number : 11938099
Drug Substance Claim :
Drug Product Claim :
Application Number : 215272
Patent Use Code : U-4048
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-11-13
Patent Expiration Date : 2039-11-13
US Patent Number : 11497718
Drug Substance Claim :
Drug Product Claim :
Application Number : 215272
Patent Use Code : U-4048
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-11-13
Patent Expiration Date : 2036-05-19
US Patent Number : 11612573
Drug Substance Claim :
Drug Product Claim :
Application Number : 215272
Patent Use Code : U-2625
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2036-05-19
Patent Expiration Date : 2036-05-19
US Patent Number : 11612573
Drug Substance Claim :
Drug Product Claim :
Application Number : 215272
Patent Use Code : U-4048
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2036-05-19
Patent Expiration Date : 2036-05-19
US Patent Number : 10426743
Drug Substance Claim :
Drug Product Claim :
Application Number : 215272
Patent Use Code : U-4048
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2036-05-19
Patent Expiration Date : 2039-11-13
US Patent Number : 11590088
Drug Substance Claim :
Drug Product Claim :
Application Number : 215272
Patent Use Code : U-2625
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2039-11-13
Patent Expiration Date : 2036-05-19
US Patent Number : 11458108
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 215272
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2036-05-19
Patent Expiration Date : 2038-11-13
US Patent Number : 11597692
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 215272
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-11-13
Patent Expiration Date : 2036-05-19
US Patent Number : 11617724
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 215272
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2036-05-19
Patent Expiration Date : 2038-11-13
US Patent Number : 10647649
Drug Substance Claim : Y
Drug Product Claim :
Application Number : 215272
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2038-11-13
ABOUT THIS PAGE
90
PharmaCompass offers a list of Tapinarof 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 Tapinarof manufacturer or Tapinarof supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Tapinarof manufacturer or Tapinarof supplier.
PharmaCompass also assists you with knowing the Tapinarof API Price utilized in the formulation of products. Tapinarof API Price is not always fixed or binding as the Tapinarof Price is obtained through a variety of data sources. The Tapinarof Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tapinarof manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tapinarof, including repackagers and relabelers. The FDA regulates Tapinarof manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tapinarof 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 Tapinarof manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tapinarof supplier is an individual or a company that provides Tapinarof active pharmaceutical ingredient (API) or Tapinarof finished formulations upon request. The Tapinarof suppliers may include Tapinarof API manufacturers, exporters, distributors and traders.
click here to find a list of Tapinarof suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tapinarof DMF (Drug Master File) is a document detailing the whole manufacturing process of Tapinarof active pharmaceutical ingredient (API) in detail. Different forms of Tapinarof DMFs exist exist since differing nations have different regulations, such as Tapinarof USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tapinarof DMF submitted to regulatory agencies in the US is known as a USDMF. Tapinarof USDMF includes data on Tapinarof's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tapinarof USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tapinarof 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 Tapinarof as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tapinarof 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 Tapinarof 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 Tapinarof and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tapinarof NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tapinarof suppliers with NDC on PharmaCompass.
Tapinarof 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 Tapinarof 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 Tapinarof GMP manufacturer or Tapinarof GMP API supplier for your needs.
A Tapinarof CoA (Certificate of Analysis) is a formal document that attests to Tapinarof's compliance with Tapinarof specifications and serves as a tool for batch-level quality control.
Tapinarof CoA mostly includes findings from lab analyses of a specific batch. For each Tapinarof 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.
Tapinarof may be tested according to a variety of international standards, such as European Pharmacopoeia (Tapinarof EP), Tapinarof JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tapinarof USP).