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Chemistry

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Also known as: Elidel, 137071-32-0, Sdz-asm 981, Sdz-asm-981, Sdz asm 981, 33-epi-chloro-33-desoxyascomycin
Molecular Formula
C43H68ClNO11
Molecular Weight
810.4  g/mol
InChI Key
KASDHRXLYQOAKZ-XDSKOBMDSA-N
FDA UNII
7KYV510875

Pimecrolimus
Pimecrolimus is a 33-epi-chloro-derivative of the ascomycin macrolactam with immunosuppressant property. Pimecrolimus binds to the receptor macrophilin-12 (FKBP-12) forming a complex that blocks the calcium-dependent signal transduction cascade mediated by calcineurin. Via dephosphorylation, calcineurin is the enzyme responsible for activating nuclear factor of activated T-cells (NF-AT), a T cell transcriptional regulatory factor. As a consequence, the synthesis and release of Th1- (T helper 1) and Th2- (T helper 2) type cytokines, and other inflammatory mediators from T-cells and mast cells are blocked and the expression of signals essential for the activation of inflammatory T-lymphocytes is inhibited. However, pimecrolimus mode of action is cell-selective and does not affect Langerhans' cells/dendritic cells and primary fibroblasts.
Pimecrolimus is a Calcineurin Inhibitor Immunosuppressant. The mechanism of action of pimecrolimus is as a Calcineurin Inhibitor.
1 2D Structure

Pimecrolimus

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-12-[(E)-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[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone
2.1.2 InChI
InChI=1S/C43H68ClNO11/c1-10-30-18-24(2)17-25(3)19-36(53-8)39-37(54-9)21-27(5)43(51,56-39)40(48)41(49)45-16-12-11-13-32(45)42(50)55-38(28(6)33(46)23-34(30)47)26(4)20-29-14-15-31(44)35(22-29)52-7/h18,20,25,27-33,35-39,46,51H,10-17,19,21-23H2,1-9H3/b24-18+,26-20+/t25-,27+,28+,29-,30+,31-,32-,33-,35+,36-,37-,38+,39+,43+/m0/s1
2.1.3 InChI Key
KASDHRXLYQOAKZ-XDSKOBMDSA-N
2.1.4 Canonical SMILES
CCC1C=C(CC(CC(C2C(CC(C(O2)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C(CC1=O)O)C)C(=CC4CCC(C(C4)OC)Cl)C)O)C)OC)OC)C)C
2.1.5 Isomeric SMILES
CC[C@@H]1/C=C(/C[C@@H](C[C@@H]([C@@H]2[C@H](C[C@H]([C@@](O2)(C(=O)C(=O)N3CCCC[C@H]3C(=O)O[C@@H]([C@@H]([C@H](CC1=O)O)C)/C(=C/[C@@H]4CC[C@@H]([C@@H](C4)OC)Cl)/C)O)C)OC)OC)C)\C
2.2 Other Identifiers
2.2.1 UNII
7KYV510875
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 33-epi-chloro-33-desoxyascomycin

2. Asm 981

3. Elidel

4. Sdz Asm 981

5. Sdz-asm-981

2.3.2 Depositor-Supplied Synonyms

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*))-

2.4 Create Date
2006-05-02
3 Chemical and Physical Properties
Molecular Weight 810.4 g/mol
Molecular Formula C43H68ClNO11
XLogP33.8
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count11
Rotatable Bond Count6
Exact Mass809.4480897 g/mol
Monoisotopic Mass809.4480897 g/mol
Topological Polar Surface Area158 Ų
Heavy Atom Count56
Formal Charge0
Complexity1440
Isotope Atom Count0
Defined Atom Stereocenter Count14
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count2
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameElidel
PubMed HealthPimecrolimus (On the skin)
Drug ClassesDermatological Agent
Drug LabelELIDEL (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 IngredientPimecrolimus
Dosage FormCream
RouteTopical
Strength1%
Market StatusPrescription
CompanyValeant Bermuda

2 of 2  
Drug NameElidel
PubMed HealthPimecrolimus (On the skin)
Drug ClassesDermatological Agent
Drug LabelELIDEL (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 IngredientPimecrolimus
Dosage FormCream
RouteTopical
Strength1%
Market StatusPrescription
CompanyValeant Bermuda

4.2 Drug Indication

For treatment of mild to moderate atopic dermatitis.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

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.


5.2 MeSH Pharmacological Classification

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.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
PIMECROLIMUS
5.3.2 FDA UNII
7KYV510875
5.3.3 Pharmacological Classes
Calcineurin Inhibitors [MoA]; Calcineurin Inhibitor Immunosuppressant [EPC]
5.4 ATC Code

D - Dermatologicals

D11 - Other dermatological preparations

D11A - Other dermatological preparations

D11AH - Agents for dermatitis, excluding corticosteroids

D11AH02 - Pimecrolimus


5.5 Absorption, Distribution and Excretion

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.


5.6 Metabolism/Metabolites

No drug metabolism was observed in human skin in vitro. Oral administration yielded metabolites produced from O-demethylation and oxygenation reactions.


5.7 Mechanism of Action

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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INCOME TAX OFFICE,, AHMEDABAD ,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1641234600,"product":"PIMECROLIMUS IH BATCH NO:SBL\/PMS\/21\/007","address":"BLOCK-A,SHOP-114,GANESH MERIDIAN,O PP.GUJ., HIGH COURT,S.G.HIGHWAY,","city":"AHMEDABAD,GUJARAT","supplier":"SUMAR BIOTECH","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"SAJA PHARMACEUTICALS EGYPT","customerCountry":"EGYPT","quantity":"0.03","actualQuantity":"25","unit":"GMS","unitRateFc":"26","totalValueFC":"550.4","currency":"USD","unitRateINR":1640,"date":"04-Jan-2022","totalValueINR":"41000","totalValueInUsd":"550.4","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"7248608","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"BLOCK-A,SHOP-114,GANESH MERIDIAN,O PP.GUJ., HIGH COURT,S.G.HIGHWAY,, AHMEDABAD,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1642703400,"product":"PIMECROLIMUS (B.NO.33121020 & 33121021 (","address":"1482 1486 TRASAD ROAD,DHOLKA","city":"AHMEDABAD,GUJARAT","supplier":"CONCORD BIOTECH","supplierCountry":"INDIA","foreign_port":"TEL AVIV YAFO","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"ISRAEL","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"85000","totalValueFC":"167142.2","currency":"USD","unitRateINR":6225500,"date":"21-Jan-2022","totalValueINR":"12451000","totalValueInUsd":"167142.2","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"7631508","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ISRAEL","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"1482 1486 TRASAD ROAD,DHOLKA, AHMEDABAD,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1656700200,"product":"PIMECROLIMUS, BATCH NO:33121023, MFG DT:","address":"1482 1486 TRASAD ROAD,DHOLKA","city":"AHMEDABAD,GUJARAT","supplier":"CONCORD BIOTECH","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"CAMBREX CORPORATION","customerCountry":"UNITED STATES","quantity":"0.31","actualQuantity":"0.31","unit":"KGS","unitRateFc":"70000","totalValueFC":"21077.4","currency":"USD","unitRateINR":5406451.6129032262,"date":"02-Jul-2022","totalValueINR":"1676000","totalValueInUsd":"21077.4","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"2552297","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"1482 1486 TRASAD ROAD,DHOLKA, AHMEDABAD,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1679682600,"product":"PIMECROLIMUS, BATCH NO:1633A122006 MFG D","address":"1482 1486 TRASAD ROAD,DHOLKA","city":"AHMEDABAD,GUJARAT","supplier":"CONCORD BIOTECH","supplierCountry":"INDIA","foreign_port":"NEW YORK - JOHN F. K","customer":"HALO PHARMA DBA CAMBREX","customerCountry":"UNITED STATES","quantity":"1.50","actualQuantity":"1.498","unit":"KGS","unitRateFc":"70000","totalValueFC":"104473.7","currency":"USD","unitRateINR":5736315.0867823763,"date":"25-Mar-2023","totalValueINR":"8593000","totalValueInUsd":"104473.7","indian_port":"AHMEDABAD AIR","hs_no":"29420090","bill_no":"8739298","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"1482 1486 TRASAD ROAD,DHOLKA, AHMEDABAD,GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1710268200,"product":"PIMECROLIMUS","address":"H N.8-2-269\/W\/4,1ST FLOOR,PLOT NO.","city":"BANJARA HILLS HYDERABAD,TELANGANA","supplier":"HRV GLOBAL LIFE SCIENCES","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"EXPERT INTERNATIONAL GENERAL TRADIN","customerCountry":"UNITED ARAB EMIRATES","quantity":"10.00","actualQuantity":"10000","unit":"GMS","unitRateFc":"107.3","totalValueFC":"283060.8","currency":"AED","unitRateINR":2350.4175,"date":"13-Mar-2024","totalValueINR":"23504175","totalValueInUsd":"283060.8","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"8274293","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"H N.8-2-269\/W\/4,1ST FLOOR,PLOT NO., BANJARA HILLS HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727634600,"product":"PIMECROLIMUS - BATCH NO.1633A124006 MFG.DT. AUG 2024 RETEST DT. JUL 2027","address":"1482-1486, TRASAD ROAD,","city":"AHMEDABAD ,GUJARAT","supplier":"CONCORD BIOTECH","supplierCountry":"INDIA","foreign_port":"DALLAS\/FT. WORTH, TX","customer":"TO ORDER","customerCountry":"UNITED STATES","quantity":"1.05","actualQuantity":"1.05","unit":"KGS","unitRateFc":"55000","totalValueFC":"56634.3","currency":"USD","unitRateINR":4520023.8095238097,"date":"30-Sep-2024","totalValueINR":"4746025","totalValueInUsd":"56634.3","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"4455622","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"1482-1486, TRASAD ROAD,, AHMEDABAD ,GUJARAT","customerAddress":""},{"dataSource":"API Import","activeIngredients":"PIMECROLIMUS","year":"2021","qtr":"Q1","strtotime":1609698600,"product":"PIMECROLIMUS . 201022_PIMECROLIMU_GLENMARK_IH","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"19.00","actualQuantity":"19","unit":"KGS","unitRateFc":"74013.2","totalValueFC":"1431499","currency":"USD","unitRateINR":"5510279.6","date":"04-Jan-2021","totalValueINR":"104695313","totalValueInUsd":"1431499","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1000033","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"PIMECROLIMUS","year":"2021","qtr":"Q2","strtotime":1619461800,"product":"PIMECROLIMUS 201022_PIMECROLIMU_GLENMARK_IH","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"21.00","actualQuantity":"21","unit":"KGS","unitRateFc":"62442.9","totalValueFC":"1341259","currency":"USD","unitRateINR":"4755023.6","date":"27-Apr-2021","totalValueINR":"99855495","totalValueInUsd":"1341259","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1002840","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1628101800,"product":"PIMECROLIMUS 201103_PIMECROLIMUS_GLENMARK_I","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"61070","totalValueFC":"1241697.5","currency":"USD","unitRateINR":"4604678","date":"05-Aug-2021","totalValueINR":"92093560","totalValueInUsd":"1241697.5","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1005448","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659292200,"product":"PIMECROLIMUS . 201103_PIMECROLIMUS_GLENMARK_I","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"59400","totalValueFC":"241729.4","currency":"USD","unitRateINR":"4808430","date":"01-Aug-2022","totalValueINR":"19233720","totalValueInUsd":"241729.4","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1005134","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1659292200,"product":"PIMECROLIMUS . 201103_PIMECROLIMUS_GLENMARK_I","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"54540","totalValueFC":"1109757.7","currency":"USD","unitRateINR":"4415013","date":"01-Aug-2022","totalValueINR":"88300260","totalValueInUsd":"1109757.7","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1005134","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1672857000,"product":"PIMECROLIMUS","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"18.00","actualQuantity":"18","unit":"KGS","unitRateFc":"52500","totalValueFC":"965695.5","currency":"USD","unitRateINR":"4386375","date":"05-Jan-2023","totalValueINR":"78954750","totalValueInUsd":"965695.5","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1000073","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1681929000,"product":"PIMECROLIMUS","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"18.00","actualQuantity":"18","unit":"KGS","unitRateFc":"55200","totalValueFC":"1004465.7","currency":"USD","unitRateINR":"4573320","date":"20-Apr-2023","totalValueINR":"82319760","totalValueInUsd":"1004465.7","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1002468","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1703269800,"product":"PIMECROLIMUS","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"48422.4","totalValueFC":"1218657.9","currency":"USD","unitRateINR":"4057797.1","date":"23-Dec-2023","totalValueINR":"101444928","totalValueInUsd":"1218657.9","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1008379","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1715279400,"product":"PIMECROLIMUS","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"21.00","actualQuantity":"21","unit":"KGS","unitRateFc":"48000","totalValueFC":"1020042.5","currency":"USD","unitRateINR":"4048800","date":"10-May-2024","totalValueINR":"85024800","totalValueInUsd":"1020042.5","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1003295","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"N\/A","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727029800,"product":"PIMECROLIMUS DB","address":"20TH K M, HOSUR ROAD,,ELECTRONIC C","city":"BANGALORE,KARNATAKA","supplier":"BIOCON BIOSPHERE LIMITED","supplierCountry":"INDIA","foreign_port":"RPCIPL SEZ","customer":"BIOCON","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"0.01","unit":"KGS","unitRateFc":"29872.9","totalValueFC":"301.6","currency":"USD","unitRateINR":"2527246","date":"23-Sep-2024","totalValueINR":"25272.46","totalValueInUsd":"301.6","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29420090","bill_no":"5747441","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"RPCIPL SEZ","supplierAddress":"Plot No.95, Vishakha Pharmacity Ltd Paravada MandalANAKAPALLI SDNF India","customerAddress":"20TH K M, HOSUR ROAD,,ELECTRONIC C"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732645800,"product":"PIMECROLIMUS","address":"B\/2 MAHALAXMI CHAMBERS","city":"MUMBAI. MAHARASHTRA","supplier":"MEDICHEM S.A","supplierCountry":"SPAIN","foreign_port":"BARCELONA","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"19.00","actualQuantity":"19","unit":"KGS","unitRateFc":"37120","totalValueFC":"713318.4","currency":"USD","unitRateINR":"3168192","date":"27-Nov-2024","totalValueINR":"60195648","totalValueInUsd":"713318.4","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1008197","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"BARCELONA","supplierAddress":"FRUCTUOS GELABERT, 6-8 08970 SANT J OAN DESP I (BARCELONA) SPAIN SPAIN","customerAddress":"B\/2 MAHALAXMI CHAMBERS"}]
04-Jan-2021
27-Nov-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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FDF Dossiers

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01

Actavis Inc

Ireland
Pharmatech Expo 2025
Not Confirmed
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Actavis Inc

Ireland
arrow
Pharmatech Expo 2025
Not Confirmed

PIMECROLIMUS

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

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02

Bausch Health

Canada
Pharmatech Expo 2025
Not Confirmed
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Bausch Health

Canada
arrow
Pharmatech Expo 2025
Not Confirmed

PIMECROLIMUS

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

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03

Pharmatech Expo 2025
Not Confirmed
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arrow
Pharmatech Expo 2025
Not Confirmed

PIMECROLIMUS

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

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04

Pharmatech Expo 2025
Not Confirmed
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arrow
Pharmatech Expo 2025
Not Confirmed

Pimecrolimus

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

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05

Pharmatech Expo 2025
Not Confirmed
arrow
arrow
Pharmatech Expo 2025
Not Confirmed

Pimecrolimus

Brand Name : Elidel

Dosage Form : CRE

Dosage Strength : 1%

Packaging : 15X1%

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Pharmatech Expo 2025
Not Confirmed
arrow
arrow
Pharmatech Expo 2025
Not Confirmed

Pimecrolimus

Brand Name : Elidel

Dosage Form : CRE

Dosage Strength : 1%

Packaging : 30X1%

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Pharmatech Expo 2025
Not Confirmed
arrow
arrow
Pharmatech Expo 2025
Not Confirmed

Pimecrolimus

Brand Name : Elidel

Dosage Form : CRE

Dosage Strength : 1%

Packaging : 60X1%

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Viatris

U.S.A
Pharmatech Expo 2025
Not Confirmed
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Viatris

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Pimecrolimus

Brand Name : Elidel

Dosage Form : Cream

Dosage Strength : 1%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

Viatris

U.S.A
Pharmatech Expo 2025
Not Confirmed
arrow

Viatris

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

Pimecrolimus

Brand Name : Elidel

Dosage Form : Cream

Dosage Strength : 1%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

blank

10

Viatris

U.S.A
Pharmatech Expo 2025
Not Confirmed
arrow

Viatris

U.S.A
arrow
Pharmatech Expo 2025
Not Confirmed

pimecrolimus

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

Pimecrolimus Manufacturers

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.

Pimecrolimus Suppliers

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.

Pimecrolimus USDMF

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.

Pimecrolimus WC

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.

Pimecrolimus NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Pimecrolimus API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Pimecrolimus CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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