Synopsis
Synopsis
0
VMF
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers


1. Augmented Betamethasone Dipropionate
2. Beloderm
3. Betamethasone Propionate
4. Betamethasone-17,21-dipropionate
5. Diprolene
6. Diprosone
7. Maxivate
1. Diprolene
2. Diprosone
3. 5593-20-4
4. Maxivate
5. Diprolene Af
6. Alphatrex
7. Diproderm
8. Psorion
9. Betamethasone 17,21-dipropionate
10. Rinderon Dp
11. Diprosis
12. Diprospan
13. Sch 11460
14. Sch-11460
15. S-3440
16. Betamethasone (as Dipropionate)
17. Betamethasone-17,21-dipropionate
18. Chebi:31276
19. Nsc-758415
20. Pregna-1,4-diene-3,20-dione,9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11b,16b)-
21. Beta-methasone 17,21-dipropionate
22. 826y60901u
23. [2-[(8s,9r,10s,11s,13s,14s,16s,17r)-9-fluoro-11-hydroxy-10,13,16-trimethyl-3-oxo-17-propanoyloxy-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl]-2-oxoethyl] Propanoate
24. (11-beta,16-beta)-9-chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
25. 9-fluoro-11beta-hydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl Dipropanoate
26. 9-fluoro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
27. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione-17,21-dipropionate
28. Einecs 227-005-2
29. Brn 3638108
30. .beta.-methasone 17,21-dipropionate
31. Betamethasone Dipropionate (diprolene)
32. S 3440
33. Diprolene (tn)
34. Unii-826y60901u
35. Ncgc00159360-02
36. Ncgc00159443-02
37. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)-
38. Sernivo (tn)
39. Rinderon-dp (tn)
40. Betamethasone Dipropionate [usan:usp:jan]
41. Betamethasone-dipropionate
42. Dsstox_cid_2672
43. Betamethasone Diprop
44. Schembl7519
45. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
46. Dsstox_rid_76683
47. Dsstox_gsid_22672
48. 9-fluoro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione 17,21-di(propionate)
49. Betamethasone-17,21-dipropionate 100 Microg/ml In Acetonitrile
50. Chembl1200384
51. Dtxsid2022672
52. Component Of Betasone (salt/mix)
53. Component Of Alphatrex (salt/mix)
54. Amy22130
55. Zinc4212137
56. Tox21_113343
57. Bdbm50421892
58. S1688
59. Akos015969733
60. Betamethasone Dipropionate (jp17/usp)
61. Ccg-269732
62. Cs-7549
63. Ks-5303
64. Nsc 758415
65. Betamethasone Dipropionate [jan]
66. Betamethasone Dipropionate [usan]
67. Ncgc00159443-01
68. Ncgc00159443-05
69. (11beta,16beta)-9-fluoro-11-hydroxy-16-methyl-3,20-dioxopregna-1,4-diene-17,21-diyl Dipropanoate
70. 2-((2s,10s,11s,13s,15s,17s,1r,14r)-1-fluoro-17-hydroxy-2,13,15-trimethyl-5-oxo -14-propanoyloxytetracyclo[8.7.0.0<2,7>.0<11,15>]heptadeca-3,6-dien-14-yl)-2-o Xoethyl Propanoate
71. Betamethasone Dipropionate [mart.]
72. Betamethasone Dipropionate [vandf]
73. Hy-13571
74. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,17,21-trihydroxy-16-beta-methyl-, 17,21-dipropionate
75. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11beta,16beta)
76. Betamethasone Dipropionate [usp-rs]
77. Betamethasone Dipropionate [who-dd]
78. Cas-5593-20-4
79. Betamethasone Dipropionate, Augmented
80. B3166
81. Betamethasone 17,21-dipropionate [mi]
82. Betamethasone Dipropionate [green Book]
83. Betamethasone Dipropionate [orange Book]
84. D01637
85. Ab01274713-01
86. Ab01274713_02
87. Betamethasone 17.alpha.,21-dipropionate
88. Betamethasone Dipropionate [ep Monograph]
89. Betamethasone Dipropionate [usp Monograph]
90. Wynzora Component Betamethasone Dipropionate
91. Enstilar Component Betamethasone Dipropionate
92. Lotrisone Component Betamethasone Dipropionate
93. Q4897349
94. Taclonex Component Betamethasone Dipropionate
95. Betamethasone Dipropionate Component Of Enstilar
96. Betamethasone Dipropionate Component Of Taclonex
97. Betamethasone Dipropionate Component Of Wynzora
98. Brd-k58148589-001-03-6
99. Leo-90100 Component Betamethasone Dipropionate
100. Betamethasone Dipropionate Component Of Lotrisone
101. Betamethasone Dipropionate Component Of Leo-90100
102. Betamethasone-17,21-dipropionate 100 Microg/ml In Methanol
103. (11.beta.,16.beta.)-9-fluoro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate
104. 9-fluoro-11.beta.-hydroxy-16.beta.-methyl-3,20-dioxo-17-(propionyloxy)pregna-1,4-dien-21-yl Propionate #
105. 9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-1,4-pregnadiene-3,20-dione 17,21-dipropionate
106. 9alpha-fluoro-11beta,17alpha,21-trihydroxy-16beta-methyl-3,20-dioxopregna-1,4-diene- 17,21-diyl Dipropionate
107. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-.beta.,17,21-trihydroxy-16-.beta.-methyl-,17,21-dipropionate
108. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxopropoxy)-, (11.beta.,16.beta.)
| Molecular Weight | 504.6 g/mol |
|---|---|
| Molecular Formula | C28H37FO7 |
| XLogP3 | 3.6 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 8 |
| Exact Mass | 504.25233168 g/mol |
| Monoisotopic Mass | 504.25233168 g/mol |
| Topological Polar Surface Area | 107 Ų |
| Heavy Atom Count | 36 |
| Formal Charge | 0 |
| Complexity | 1050 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 8 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 6 | |
|---|---|
| Drug Name | Betamethasone dipropionate |
| PubMed Health | Betamethasone Dipropionate (On the skin) |
| Drug Classes | Corticosteroid, Strong |
| Drug Label | Betamethasone Dipropionate Lotion USP 0.05% (Augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a sli... |
| Active Ingredient | Betamethasone dipropionate |
| Dosage Form | Lotion; Ointment, augmented; Ointment; Lotion, augmented; Cream; Cream, augmented; Gel, augmented |
| Route | Topical |
| Strength | eq 0.05% base |
| Market Status | Prescription |
| Company | Glenmark Generics; Fougera Pharms; Actavis Mid Atlantic; Teva; Perrigo New York; Taro; Fougera; Tolmar |
| 2 of 6 | |
|---|---|
| Drug Name | Diprolene |
| PubMed Health | Betamethasone Dipropionate, Augmented (On the skin) |
| Drug Classes | Corticosteroid, Very Strong |
| Drug Label | DIPROLENE (augmented betamethasone dipropionate) Ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a... |
| Active Ingredient | Betamethasone dipropionate |
| Dosage Form | Ointment, augmented; Lotion, augmented |
| Route | Topical |
| Strength | eq 0.05% base |
| Market Status | Prescription |
| Company | Merck Sharp Dohme |
| 3 of 6 | |
|---|---|
| Drug Name | Diprolene af |
| PubMed Health | Betamethasone Dipropionate, Augmented (On the skin) |
| Drug Classes | Corticosteroid, Very Strong |
| Drug Label | DIPROLENE AF Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degre... |
| Active Ingredient | Betamethasone dipropionate |
| Dosage Form | Cream, augmented |
| Route | Topical |
| Strength | eq 0.05% base |
| Market Status | Prescription |
| Company | Merck Sharp Dohme |
| 4 of 6 | |
|---|---|
| Drug Name | Betamethasone dipropionate |
| PubMed Health | Betamethasone Dipropionate (On the skin) |
| Drug Classes | Corticosteroid, Strong |
| Drug Label | Betamethasone Dipropionate Lotion USP 0.05% (Augmented) contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a sli... |
| Active Ingredient | Betamethasone dipropionate |
| Dosage Form | Lotion; Ointment, augmented; Ointment; Lotion, augmented; Cream; Cream, augmented; Gel, augmented |
| Route | Topical |
| Strength | eq 0.05% base |
| Market Status | Prescription |
| Company | Glenmark Generics; Fougera Pharms; Actavis Mid Atlantic; Teva; Perrigo New York; Taro; Fougera; Tolmar |
| 5 of 6 | |
|---|---|
| Drug Name | Diprolene |
| PubMed Health | Betamethasone Dipropionate, Augmented (On the skin) |
| Drug Classes | Corticosteroid, Very Strong |
| Drug Label | DIPROLENE (augmented betamethasone dipropionate) Ointment contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a... |
| Active Ingredient | Betamethasone dipropionate |
| Dosage Form | Ointment, augmented; Lotion, augmented |
| Route | Topical |
| Strength | eq 0.05% base |
| Market Status | Prescription |
| Company | Merck Sharp Dohme |
| 6 of 6 | |
|---|---|
| Drug Name | Diprolene af |
| PubMed Health | Betamethasone Dipropionate, Augmented (On the skin) |
| Drug Classes | Corticosteroid, Very Strong |
| Drug Label | DIPROLENE AF Cream 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for dermatologic use in an emollient base. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degre... |
| Active Ingredient | Betamethasone dipropionate |
| Dosage Form | Cream, augmented |
| Route | Topical |
| Strength | eq 0.05% base |
| Market Status | Prescription |
| Company | Merck Sharp Dohme |
Anti-Inflammatory Agents
Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-02
Pay. Date : 2016-02-12
DMF Number : 25798
Submission : 2012-02-16
Status : Active
Type : II
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0161
Address of the Firm :
NDC Package Code : 22552-0028
Start Marketing Date : 2011-08-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24486
Submission : 2010-10-12
Status : Active
Type : II
Certificate Number : CEP 2011-005 - Rev 02
Issue Date : 2024-12-23
Type : Chemical
Substance Number : 809
Status : Valid
Date of Issue : 2025-05-20
Valid Till : 2028-05-22
Written Confirmation Number : 3923/25
Address of the Firm :
NDC Package Code : 52128-160
Start Marketing Date : 2011-11-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-12-21
Registration Number : 20211221-211-J-1097
Manufacturer Name : Symbiotica Specialty Ingredients Sdn. Bhd.
Manufacturer Address : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 23118
Submission : 2009-09-16
Status : Active
Type : II
Certificate Number : R1-CEP 2003-232 - Rev 03
Issue Date : 2023-02-08
Type : Chemical
Substance Number : 809
Status : Valid
NDC Package Code : 46439-8710
Start Marketing Date : 1989-05-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : SAU |
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-13
Pay. Date : 2015-04-02
DMF Number : 4148
Submission : 1981-04-28
Status : Active
Type : II
Certificate Number : CEP 2000-223 - Rev 09
Issue Date : 2025-08-08
Type : Chemical
Substance Number : 809
Status : Valid
| Available Reg Filing : CA, ASMF |
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-02
Pay. Date : 2016-02-12
DMF Number : 25798
Submission : 2012-02-16
Status : Active
Type : II
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24486
Submission : 2010-10-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-07
Pay. Date : 2013-09-26
DMF Number : 23118
Submission : 2009-09-16
Status : Active
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2015-04-13
Pay. Date : 2015-04-02
DMF Number : 4148
Submission : 1981-04-28
Status : Active
Type : II
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-05
Pay. Date : 2015-09-24
DMF Number : 17046
Submission : 2003-12-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5157
Submission : 1983-11-23
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5274
Submission : 1984-03-01
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7095
Submission : 1987-08-04
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6726
Submission : 1986-11-26
Status : Inactive
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
Certificate Number : CEP 2011-005 - Rev 02
Status : Valid
Issue Date : 2024-12-23
Type : Chemical
Substance Number : 809
Betamethasone Dipropionate, Micronised
Certificate Number : R1-CEP 2003-232 - Rev 03
Status : Valid
Issue Date : 2023-02-08
Type : Chemical
Substance Number : 809
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Certificate Number : CEP 2000-223 - Rev 09
Status : Valid
Issue Date : 2025-08-08
Type : Chemical
Substance Number : 809
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
Certificate Number : R1-CEP 2002-031 - Rev 03
Status : Valid
Issue Date : 2021-08-24
Type : Chemical
Substance Number : 809
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Certificate Number : R0-CEP 2020-418 - Rev 00
Status : Valid
Issue Date : 2022-05-24
Type : Chemical
Substance Number : 809

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Certificate Number : CEP 2022-342 - Rev 00
Status : Valid
Issue Date : 2024-04-30
Type : Chemical
Substance Number : 809

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF

Betamethasone Dipropionate, Micronised
Certificate Number : CEP 2012-079 - Rev 01
Status : Valid
Issue Date : 2026-04-01
Type : Chemical
Substance Number : 809

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF

Betamethasone Dipropionate, Micronised
Certificate Number : CEP 2018-018 - Rev 04
Status : Valid
Issue Date : 2026-02-23
Type : Chemical
Substance Number : 809

Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] Betamethasone Dipropionate BP/EP/USP
Date of Issue : 2025-09-03
Valid Till : 2028-09-02
Written Confirmation Number : WC-0161
Address of the Firm : 385/2, Gram Pigdamber, Rau , Indore-453331, Madhya Pradesh, India
Betamethasone Dipropionate BP/EP/USP
Date of Issue : 2022-08-31
Valid Till : 2025-07-02
Written Confirmation Number : WC-0162Amended
Address of the Firm : Plot No. 5,6,7 & 8, Special Economic Zone, Phase II, Pharma Zone, Pithampur, Dis...
Betamethasone Dipropionate BP/EP/USP
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161n
Address of the Firm : PLOT NO.385/2, Gram Pigdamber, Rau , Indore-453331, Madhya Pradesh, India
Betamethasone Dipropionate BP/EP/USP
Date of Issue : 2022-06-30
Valid Till : 2025-07-02
Written Confirmation Number : WC-0161A2
Address of the Firm : 385/2, Gram Pigdamber, Rau, Indore-453331, M.P., India
Betamethasone Dipropionate BP/EP/USP
Date of Issue : 2022-07-23
Valid Till : 2025-02-07
Written Confirmation Number : WC-0162n
Address of the Firm : Plot No-5,6,7 & 8, Special Economic Zone, Phase-II, Pharma Zone, Pithampur, Dist...
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
Date of Issue : 2025-05-20
Valid Till : 2028-05-22
Written Confirmation Number : 3923/25
Address of the Firm : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia
Betamethasone Dipropionate EP/BP/USP
Date of Issue : 2024-09-24
Valid Till : 2028-07-02
Written Confirmation Number : WC-0169
Address of the Firm : Plot No. -A-1/7 & A-1/8, 1st Phase, G.I.D.C. Vapі, Dist. -Valsad -396195, Gujar...

Betamethasone Dipropionate BP/USP
Date of Issue : 2022-06-07
Valid Till : 2024-10-07
Written Confirmation Number : WC-0429
Address of the Firm : NH No. 8, Post -Dumral, Tal: Nadiad, Dumral-387355, Dist: Kheda, Gujarat, India

Betamethasone Dipropionate/BP/USP/EP
Date of Issue : 2025-12-24
Valid Till : 2028-07-02
Written Confirmation Number : WC-0247
Address of the Firm : Plot No 0-5/8, D-5/9, MIDC Turbhe, Mumbai-400703, Maharashtra, India

Date of Issue : 2025-12-17
Valid Till : 2028-12-16
Written Confirmation Number : WC-0241
Address of the Firm : Plot No 409, Phase IV G.I.D.C. Ind. Estate Naroda, Ahmedabad, Gujarat, India

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2021-12-21
Registration Number : 20211221-211-J-1097
Manufacturer Name : Symbiotica Specialty Ingredi...
Manufacturer Address : No. 518, Jalan Waja 4, Taman Industri Waja, 09000 Kulim, Kedah, Malaysia
Registrant Name : Hiple Co., Ltd.
Registration Date : 2021-04-27
Registration Number : 20210427-211-J-955
Manufacturer Name : Avik Pharmaceutical Limited
Manufacturer Address : A-1/7 & A-1/8, 1ST Phase, GIDC, City : Vapi - 396 195, Dist. Valsad, Gujarat State, I...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 22552-0028
Start Marketing Date : 2011-08-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
NDC Package Code : 52128-160
Start Marketing Date : 2011-11-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 46439-8710
Start Marketing Date : 1989-05-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Curia - Accelerating therapies from discovery to commercialization with flexible, scalable CDMO solutions.
NDC Package Code : 65089-0009
Start Marketing Date : 1984-10-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 62991-1023
Start Marketing Date : 2011-05-25
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

NDC Package Code : 38779-0017
Start Marketing Date : 2015-07-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

NDC Package Code : 24002-0019
Start Marketing Date : 2009-08-03
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 51927-1454
Start Marketing Date : 2013-06-27
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

NDC Package Code : 51927-0171
Start Marketing Date : 2011-10-19
End Marketing Date : 2027-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

NDC Package Code : 53183-0433
Start Marketing Date : 2017-11-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : Symbiotec, based in Indore, India, is a leading API manufacturer specializing in cortico-steroids and steroid-hormone APIs since 1995. Focused on R&D, sustainability, and innovatio...
Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.
About the Company : Symbiotica is a Malaysia-based manufacturer of high-quality Active Pharmaceutical Ingredients (APIs), specialising in steroidal, hormonal, and niche non-steroidal compounds for glo...
About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
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 legacy of advancing health through innovation. Today, we offer one of the industry’s most comprehensive API portfolios ...
SWATI - Transforming science into solutions with 60+ years of expertise, global accreditations, and pioneering biotech innovation.
About the Company : Swati Spentose Pvt. Ltd. (SSPL), part of the 60-year-old V Group, is a globally trusted pharmaceutical manufacturer supplying to 70+ countries. We specialize in high-quality APIs a...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
The agreement aims to commercialize Wynzora Cream, a combination of calcipotriene and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis, in Canada.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Brand Name: Wynzora
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Endo Pharm
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 15, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Calcipotriol,Betamethasone Dipropionate
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Endo Pharm
Deal Size : Undisclosed
Deal Type : Agreement
Endo Announces Agreement for Paladin Pharma to Commercialize Wynzora® Cream in Canada
Details : The agreement aims to commercialize Wynzora Cream, a combination of calcipotriene and betamethasone dipropionate, a corticosteroid, indicated for the topical treatment of plaque psoriasis, in Canada.
Product Name : Wynzora
Product Type : Miscellaneous
Upfront Cash : Undisclosed
November 15, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
Enstilar is a combination of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid, indicated as topical treatment of plaque psoriasis.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Brand Name: Enstilar
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 27, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Calcipotriol,Betamethasone Dipropionate
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
LEO Pharma Submits NDA For Enstilar® For Psoriasis Treatment in China
Details : Enstilar is a combination of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid, indicated as topical treatment of plaque psoriasis.
Product Name : Enstilar
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 27, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
MC2 gains commercialization rights for Wynzora, an approved product indicated for treating plaque psoriasis in patients 18 years and older, through a license agreement.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Brand Name: Wynzora
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Hyphens Pharma
Deal Size: $2.7 million Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 12, 2024

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Calcipotriol,Betamethasone Dipropionate
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Hyphens Pharma
Deal Size : $2.7 million
Deal Type : Licensing Agreement
Hyphens Pharma licenses Wynzora® Cream for ASEAN countries from MC2 Therapeutics
Details : MC2 gains commercialization rights for Wynzora, an approved product indicated for treating plaque psoriasis in patients 18 years and older, through a license agreement.
Product Name : Wynzora
Product Type : Miscellaneous
Upfront Cash : Undisclosed
March 12, 2024

Details:
Betamethasone Dipropionate is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Psoriasis.
Lead Product(s): Betamethasone Dipropionate,Tapinarof
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase II/ Phase IIIProduct Type: Miscellaneous
Sponsor: Dermavant Sciences
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 08, 2023

Lead Product(s) : Betamethasone Dipropionate,Tapinarof
Therapeutic Area : Dermatology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Dermavant Sciences
Deal Size : Inapplicable
Deal Type : Inapplicable
Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)
Details : Betamethasone Dipropionate is a Other Small Molecule drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Psoriasis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 08, 2023

Details:
Betamethasone Dipropionate is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Rhinosinusitis.
Lead Product(s): Betamethasone Dipropionate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 31, 2023

Lead Product(s) : Betamethasone Dipropionate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Betamethasone Dipropionate is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Rhinosinusitis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 31, 2023

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
The product is the combination of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. It is indicated for the topical treatment of plaque psoriasis.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Brand Name: Enstilar-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 23, 2023

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Calcipotriol,Betamethasone Dipropionate
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The product is the combination of calcipotriene hydrate as a synthetic vitamin D3 analog and betamethasone dipropionate as a synthetic corticosteroid. It is indicated for the topical treatment of plaque psoriasis.
Product Name : Enstilar-Generic
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 23, 2023

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
WYNZORA is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. It is based on PAD™ Technology, which enables stability of both calcipotriene and betamethasone dipropionate in aqueous formulation.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Brand Name: Wynzora
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: MC2 Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 15, 2022

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Calcipotriol,Betamethasone Dipropionate
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : MC2 Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
EPI Health, a Novan Company, and MC2 Therapeutics Present WYNZORA® (calcipotriene and betamethaso...
Details : WYNZORA is a cream-based fixed dose combination of calcipotriene and betamethasone dipropionate for topical treatment of plaque psoriasis. It is based on PAD™ Technology, which enables stability of both calcipotriene and betamethasone dipropionate in a...
Product Name : Wynzora
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 15, 2022

Details:
Betamethasone Dipropionate is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Rhinosinusitis.
Lead Product(s): Betamethasone Dipropionate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 02, 2022

Lead Product(s) : Betamethasone Dipropionate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Treatment of Eosinophilic Chronic Rhinosinusitis Utilizing Betamethasone Dipropionate Nasal Cream
Details : Betamethasone Dipropionate is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of Rhinosinusitis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 02, 2022

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
In this collaboration Almirall will commercialize Wynzora® Cream for treatment of plaque psoriasis in Europe and MC2 Therapeutics will be responsible for manufacturing and supply.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Brand Name: Wynzora
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Almirall
Deal Size: Undisclosed Upfront Cash: $18.0 million
Deal Type: Collaboration February 17, 2021

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Calcipotriol,Betamethasone Dipropionate
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Almirall
Deal Size : Undisclosed
Deal Type : Collaboration
Almirall and MC2 Therapeutics Ink Collaboration for European Rights to Wynzora® Cream for Plaque ...
Details : In this collaboration Almirall will commercialize Wynzora® Cream for treatment of plaque psoriasis in Europe and MC2 Therapeutics will be responsible for manufacturing and supply.
Product Name : Wynzora
Product Type : Miscellaneous
Upfront Cash : $18.0 million
February 17, 2021

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Details:
U.S. Prescribing Information (USPI) updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly topical treatment with Enstilar® (calcipotriene and betamethasone dipropionate) Foam in adults with plaque psoriasis.
Lead Product(s): Calcipotriol,Betamethasone Dipropionate
Therapeutic Area: Dermatology Brand Name: Enstilar
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 22, 2020

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.
Lead Product(s) : Calcipotriol,Betamethasone Dipropionate
Therapeutic Area : Dermatology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
LEO Pharma Announces U.S. FDA Approval for Enstilar® (Calcipotriene and Betamethasone Dipropionat...
Details : U.S. Prescribing Information (USPI) updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly topical treatment with Enstilar® (calcipotriene and betamethasone dipropionate) Foam in adults with plaque psoriasis.
Product Name : Enstilar
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 22, 2020

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
Global Sales Information
Market Place
Patents & EXCLUSIVITIES
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
82
PharmaCompass offers a list of Betamethasone Dipropionate 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 Betamethasone Dipropionate manufacturer or Betamethasone Dipropionate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Betamethasone Dipropionate manufacturer or Betamethasone Dipropionate supplier.
A Rinderon DP manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rinderon DP, including repackagers and relabelers. The FDA regulates Rinderon DP manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rinderon DP 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 Rinderon DP manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Rinderon DP supplier is an individual or a company that provides Rinderon DP active pharmaceutical ingredient (API) or Rinderon DP finished formulations upon request. The Rinderon DP suppliers may include Rinderon DP API manufacturers, exporters, distributors and traders.
click here to find a list of Rinderon DP suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Rinderon DP DMF (Drug Master File) is a document detailing the whole manufacturing process of Rinderon DP active pharmaceutical ingredient (API) in detail. Different forms of Rinderon DP DMFs exist exist since differing nations have different regulations, such as Rinderon DP USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rinderon DP DMF submitted to regulatory agencies in the US is known as a USDMF. Rinderon DP USDMF includes data on Rinderon DP's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rinderon DP USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rinderon DP suppliers with USDMF on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Rinderon DP Drug Master File in Japan (Rinderon DP JDMF) empowers Rinderon DP API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Rinderon DP JDMF during the approval evaluation for pharmaceutical products. At the time of Rinderon DP JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Rinderon DP suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Rinderon DP Drug Master File in Korea (Rinderon DP KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rinderon DP. The MFDS reviews the Rinderon DP KDMF as part of the drug registration process and uses the information provided in the Rinderon DP KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rinderon DP KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Rinderon DP API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rinderon DP suppliers with KDMF on PharmaCompass.
A Rinderon DP CEP of the European Pharmacopoeia monograph is often referred to as a Rinderon DP Certificate of Suitability (COS). The purpose of a Rinderon DP CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rinderon DP EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rinderon DP to their clients by showing that a Rinderon DP CEP has been issued for it. The manufacturer submits a Rinderon DP CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rinderon DP CEP holder for the record. Additionally, the data presented in the Rinderon DP CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rinderon DP DMF.
A Rinderon DP CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rinderon DP 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 Rinderon DP suppliers with CEP (COS) on PharmaCompass.
A Rinderon DP written confirmation (Rinderon DP WC) is an official document issued by a regulatory agency to a Rinderon DP manufacturer, verifying that the manufacturing facility of a Rinderon DP active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rinderon DP APIs or Rinderon DP finished pharmaceutical products to another nation, regulatory agencies frequently require a Rinderon DP WC (written confirmation) as part of the regulatory process.
click here to find a list of Rinderon DP suppliers with Written Confirmation (WC) 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 Rinderon DP as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rinderon DP 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 Rinderon DP 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 Rinderon DP and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rinderon DP NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rinderon DP suppliers with NDC on PharmaCompass.
Rinderon DP 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 Rinderon DP GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Rinderon DP GMP manufacturer or Rinderon DP GMP API supplier for your needs.
A Rinderon DP CoA (Certificate of Analysis) is a formal document that attests to Rinderon DP's compliance with Rinderon DP specifications and serves as a tool for batch-level quality control.
Rinderon DP CoA mostly includes findings from lab analyses of a specific batch. For each Rinderon DP 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.
Rinderon DP may be tested according to a variety of international standards, such as European Pharmacopoeia (Rinderon DP EP), Rinderon DP JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rinderon DP USP).