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1. 33-epi-chloro-33-desoxyascomycin
2. Asm 981
3. Elidel
4. Sdz Asm 981
5. Sdz-asm-981
1. Elidel
2. 137071-32-0
3. Sdz-asm 981
4. Sdz-asm-981
5. Sdz Asm 981
6. 33-epi-chloro-33-desoxyascomycin
7. Asm 981
8. 7kyv510875
9. Elidel (tn)
10. Pimecrolimus [usan:inn:ban]
11. 1000802-56-1
12. 33-epichloro-33-desoxyascomycin
13. Pimecrolimus (jan/usan/inn)
14. Unii-7kyv510875
15. Asm-981
16. Asm-998
17. Ncgc00167506-01
18. Pimecrolimus (elidel)
19. Pimecrolimus [mi]
20. (-)-pimecrolimus
21. Pimecrolimus [inn]
22. Pimecrolimus [jan]
23. Pimecrolimus [usan]
24. Pimecrolimus [vandf]
25. Pimecrolimus [mart.]
26. Pimecrolimus [who-dd]
27. Schembl438880
28. Sdz Asm-981
29. Gtpl6783
30. Schembl3000675
31. Chembl1200686
32. Pimecrolimus, >=97% (hplc)
33. Chebi:135888
34. Pimecrolimus [orange Book]
35. Ex-a2138
36. Bdbm50248356
37. Mfcd00901792
38. S5004
39. Zinc85536990
40. Akos015895946
41. Ccg-270502
42. Db00337
43. Ncgc00167506-04
44. Hy-13723
45. B1817
46. D05480
47. Ab01566841_01
48. 071p320
49. Q417489
50. Q-201579
51. Brd-k92107055-001-01-9
52. (1r,9s,12s,13r,14s,17r,18e,21s,23s,24r,25s,27r)-12-[(1e)-1-[(1r,3r,4s)-4-chloro-3-methoxycyclohexyl]prop-1-en-2-yl]-17-ethyl-1,14-dihydroxy-23,25-dimethoxy-13,19,21,27-tetramethyl-11,28-dioxa-4-azatricyclo[22.3.1.0?,?]octacos-18-ene-2,3,10,16-tetrone
53. (3s,4r,5s,8r,9e,12s,14s,15r,16s,18r,19r,26as)-3-((e)-2-((1r,3r,4s)-4-chloro-3-methoxycyclohexyl)-1-methylvinyl)-8-ethyl-5,6,8,11,12,13,14,15,16,17,18,19,24,26,26a-hexadecahydro-5,19-epoxy-3h-pyrido(2,1-c)(1,4)oxaazacyclotricosine-1,17,20,21(4h,23h)-tetrone
54. 15,19-epoxy-3h-pyrido(2,1-c)(1,4)oxaazacyclotricosine-1,7,20,21(4h,23h)-tetrone, 3-((1e)-2-((1r,3r,4s)-4-chloro-3-methoxycyclohexyl)-1-methylethenyl)-8-ethyl-5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-14,16-dimethoxy-4,10,12,18-tetramethyl-, (3s,4r,5s,8r,9e,12s,14s,15r,16s,18r,19r,26as)-
55. 15,19-epoxy-3h-pyrido(2,1-c)(1,4)oxaazacyclotricosine-1,7,20,21(4h,23h)-tetrone, 3-(2-(4-chloro-3-methoxycyclohexyl)-1-methylethenyl)-8-ethyl-, 5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a-hexadecahydro-5,19-dihydroxy-14,16-dimethoxy-4,10,12,18-tetramethyl-, (3s-(3r*(e(1s*,3s*,4r*)),4s*,5r*,8s*,9e,12r*,14r*,15s*,16r*,18s*,19s*,26ar*))-
Molecular Weight | 810.4 g/mol |
---|---|
Molecular Formula | C43H68ClNO11 |
XLogP3 | 3.8 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 6 |
Exact Mass | 809.4480897 g/mol |
Monoisotopic Mass | 809.4480897 g/mol |
Topological Polar Surface Area | 158 Ų |
Heavy Atom Count | 56 |
Formal Charge | 0 |
Complexity | 1440 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 14 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 2 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Elidel |
PubMed Health | Pimecrolimus (On the skin) |
Drug Classes | Dermatological Agent |
Drug Label | ELIDEL (pimecrolimus) Cream 1% contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin.Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chl... |
Active Ingredient | Pimecrolimus |
Dosage Form | Cream |
Route | Topical |
Strength | 1% |
Market Status | Prescription |
Company | Valeant Bermuda |
2 of 2 | |
---|---|
Drug Name | Elidel |
PubMed Health | Pimecrolimus (On the skin) |
Drug Classes | Dermatological Agent |
Drug Label | ELIDEL (pimecrolimus) Cream 1% contains the compound pimecrolimus, the immunosuppressant 33-epi-chloro-derivative of the macrolactam ascomycin.Chemically, pimecrolimus is (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(1E)-2-{(1R,3R,4S)-4-chl... |
Active Ingredient | Pimecrolimus |
Dosage Form | Cream |
Route | Topical |
Strength | 1% |
Market Status | Prescription |
Company | Valeant Bermuda |
For treatment of mild to moderate atopic dermatitis.
FDA Label
Pimecrolimus is a chemical that is used to treat atopic dermatitis (eczema). Atopic dermatitis is a skin condition characterized by redness, itching, scaling and inflammation of the skin. The cause of atopic dermatitis is not known; however, scientists believe that it may be due to activation of the immune system by various environmental or emotional triggers. Scientists do not know exactly how pimecrolimus reduces the manifestations of atopic dermatitis, but pimecrolimus reduces the action of T-cells and mast cells which are part of the immune system and contribute to responses of the immune system. Pimecrolimus prevents the activation of T-cells by blocking the effects of chemicals (cytokines) released by the body that stimulate T-cells. Pimecrolimus also reduces the ability of mast cells to release chemicals that promote inflammation.
Anti-Inflammatory Agents, Non-Steroidal
Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)
Calcineurin Inhibitors
Compounds that inhibit or block the PHOSPHATASE activity of CALCINEURIN. (See all compounds classified as Calcineurin Inhibitors.)
Dermatologic Agents
Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)
Immunosuppressive Agents
Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)
D - Dermatologicals
D11 - Other dermatological preparations
D11A - Other dermatological preparations
D11AH - Agents for dermatitis, excluding corticosteroids
D11AH02 - Pimecrolimus
Absorption
Because of the low systemic absorption of pimecrolimus following topical application the calculation of standard pharmacokinetic measures such as AUC, Cmax, half-life, etc. cannot be reliably done.
Route of Elimination
80% of the drug is excreted in the feces.
No drug metabolism was observed in human skin in vitro. Oral administration yielded metabolites produced from O-demethylation and oxygenation reactions.
Pimecrolimus binds with high affinity to macrophilin-12 (FKBP-12) and inhibits the calcium-dependent phosphatase, calcineurin. As a consequence, it inhibits T cell activation by blocking the transcription of early cytokines. In particular, pimecrolimus inhibits at nanomolar concentrations Interleukin-2 and interferon gamma (Th1-type) and Interleukin-4 and Interleukin-10 (Th2-type) cytokine synthesis in human T cells. Also, pimecrolimus prevents the release of inflammatory cytokines and mediators from mast cells in vitro after stimulation by antigen/lgE.
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GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-07
Pay. Date : 2015-07-15
DMF Number : 29481
Submission : 2015-07-15
Status : Active
Type : II
NDC Package Code : 16436-0115
Start Marketing Date : 2014-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (75kg/75kg)
Marketing Category : BULK INGREDIENT
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GDUFA
DMF Review : Reviewed
Rev. Date : 2016-03-03
Pay. Date : 2016-01-21
DMF Number : 30090
Submission : 2015-12-30
Status : Active
Type : II
NDC Package Code : 62227-024
Start Marketing Date : 2022-08-18
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-18
Pay. Date : 2014-12-30
DMF Number : 29390
Submission : 2015-09-30
Status : Active
Type : II
Date of Issue : 2022-04-13
Valid Till : 2025-07-02
Written Confirmation Number : WC-0109A
Address of the Firm :
NDC Package Code : 65727-045
Start Marketing Date : 2014-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-15
Pay. Date : 2018-01-24
DMF Number : 32348
Submission : 2017-12-14
Status : Active
Type : II
NDC Package Code : 55486-1585
Start Marketing Date : 2012-06-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Regulatory Info : RX
Registration Country : USA
Brand Name : PIMECROLIMUS
Dosage Form : CREAM;TOPICAL
Dosage Strength : 1%
Packaging :
Approval Date : 2018-12-27
Application Number : 209345
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Canada
Brand Name : ELIDEL
Dosage Form : CREAM
Dosage Strength : 1%/W/W
Packaging : 30/60/100G
Approval Date :
Application Number : 2247238
Regulatory Info :
Registration Country : Canada
Regulatory Info : RX
Registration Country : USA
Brand Name : PIMECROLIMUS
Dosage Form : CREAM;TOPICAL
Dosage Strength : 1%
Packaging :
Approval Date : 2019-08-29
Application Number : 211769
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Elidel
Dosage Form : Pimecrolimus 1% 30G Cream Dermatological Use
Dosage Strength : cream derm 30 g 1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Elidel
Dosage Form : CRE
Dosage Strength : 1%
Packaging : 15X1%
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Elidel
Dosage Form : CRE
Dosage Strength : 1%
Packaging : 30X1%
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Elidel
Dosage Form : CRE
Dosage Strength : 1%
Packaging : 60X1%
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Switzerland
Brand Name : Elidel
Dosage Form : Cream
Dosage Strength : 1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Elidel
Dosage Form : Cream
Dosage Strength : 1%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Australia
Brand Name : Elidel
Dosage Form : cream
Dosage Strength : 1%
Packaging : 1
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
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ABOUT THIS PAGE
A Pimecrolimus manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pimecrolimus, including repackagers and relabelers. The FDA regulates Pimecrolimus manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pimecrolimus 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 Pimecrolimus manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pimecrolimus supplier is an individual or a company that provides Pimecrolimus active pharmaceutical ingredient (API) or Pimecrolimus finished formulations upon request. The Pimecrolimus suppliers may include Pimecrolimus API manufacturers, exporters, distributors and traders.
click here to find a list of Pimecrolimus suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pimecrolimus DMF (Drug Master File) is a document detailing the whole manufacturing process of Pimecrolimus active pharmaceutical ingredient (API) in detail. Different forms of Pimecrolimus DMFs exist exist since differing nations have different regulations, such as Pimecrolimus USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pimecrolimus DMF submitted to regulatory agencies in the US is known as a USDMF. Pimecrolimus USDMF includes data on Pimecrolimus's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pimecrolimus USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pimecrolimus suppliers with USDMF on PharmaCompass.
A Pimecrolimus written confirmation (Pimecrolimus WC) is an official document issued by a regulatory agency to a Pimecrolimus manufacturer, verifying that the manufacturing facility of a Pimecrolimus active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Pimecrolimus APIs or Pimecrolimus finished pharmaceutical products to another nation, regulatory agencies frequently require a Pimecrolimus WC (written confirmation) as part of the regulatory process.
click here to find a list of Pimecrolimus 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 Pimecrolimus as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pimecrolimus 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 Pimecrolimus 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 Pimecrolimus and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pimecrolimus NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pimecrolimus suppliers with NDC on PharmaCompass.
Pimecrolimus 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 Pimecrolimus 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 Pimecrolimus GMP manufacturer or Pimecrolimus GMP API supplier for your needs.
A Pimecrolimus CoA (Certificate of Analysis) is a formal document that attests to Pimecrolimus's compliance with Pimecrolimus specifications and serves as a tool for batch-level quality control.
Pimecrolimus CoA mostly includes findings from lab analyses of a specific batch. For each Pimecrolimus 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.
Pimecrolimus may be tested according to a variety of international standards, such as European Pharmacopoeia (Pimecrolimus EP), Pimecrolimus JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pimecrolimus USP).
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