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    Chemistry

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    Also known as: 131918-61-1, Zemplar, Compound 49510, 19-nor-1alpha,25-dihydroxyvitamin d2, Paracalcin, Compound-49510
    Molecular Formula
    C27H44O3
    Molecular Weight
    416.6  g/mol
    InChI Key
    BPKAHTKRCLCHEA-UBFJEZKGSA-N
    FDA UNII
    6702D36OG5
    Paricalcitol
    Paricalcitol is a synthetic noncalcemic, nonphosphatemic vitamin D analogue. Paricalcitol binds to the vitamin D receptor and has been shown to reduce parathyroid hormone (PTH) levels. This agent also increases the expression of PTEN ('Phosphatase and Tensin homolog deleted on chromosome Ten'), a tumor-suppressor gene, in leukemic cells and cyclin-dependent kinase inhibitors, resulting in tumor cell apoptosis and tumor cell differentiation into normal phenotypes. (NCI04)
    Paricalcitol is a Vitamin D2 Analog.
    1 2D Structure

    Paricalcitol

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1R,3R)-5-[(2E)-2-[(1R,3aS,7aR)-1-[(E,2R,5S)-6-hydroxy-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]cyclohexane-1,3-diol
    2.1.2 InChI
    InChI=1S/C27H44O3/c1-18(8-9-19(2)26(3,4)30)24-12-13-25-21(7-6-14-27(24,25)5)11-10-20-15-22(28)17-23(29)16-20/h8-11,18-19,22-25,28-30H,6-7,12-17H2,1-5H3/b9-8+,21-11+/t18-,19+,22-,23-,24-,25+,27-/m1/s1
    2.1.3 InChI Key
    BPKAHTKRCLCHEA-UBFJEZKGSA-N
    2.1.4 Canonical SMILES
    CC(C=CC(C)C(C)(C)O)C1CCC2C1(CCCC2=CC=C3CC(CC(C3)O)O)C
    2.1.5 Isomeric SMILES
    C[C@H](/C=C/[C@H](C)C(C)(C)O)[C@H]1CC[C@@H]\2[C@@]1(CCC/C2=C\C=C3C[C@H](C[C@@H](C3)O)O)C
    2.2 Other Identifiers
    2.2.1 UNII
    6702D36OG5
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 19-nor-1,25-(oh)2d2

    2. 19-nor-1alpha,25-dihydroxyvitamin D2

    3. Paricalcitol-d6

    4. Zemplar

    2.3.2 Depositor-Supplied Synonyms

    1. 131918-61-1

    2. Zemplar

    3. Compound 49510

    4. 19-nor-1alpha,25-dihydroxyvitamin D2

    5. Paracalcin

    6. Compound-49510

    7. (1r,3r)-5-[(2e)-2-[(1r,3as,7ar)-1-[(e,2r,5s)-6-hydroxy-5,6-dimethylhept-3-en-2-yl]-7a-methyl-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]cyclohexane-1,3-diol

    8. Chebi:7931

    9. 6702d36og5

    10. (1r,3r,7e)-17beta-[(2r,3e,5s)-6-hydroxy-5,6-dimethylhept-3-en-2-yl]-9,10-secoestra-5,7-diene-1,3-diol

    11. Ncgc00182706-01

    12. Paricalcitol [usan]

    13. 19-nor-1,25-(oh)2d2

    14. Zemplar (tn)

    15. 19-nor-1-alpha,25-dihydroxyvitamin D2

    16. Hsdb 7360

    17. Paricalcitol [usan:usp:inn]

    18. Unii-6702d36og5

    19. Abt-358

    20. (7e,22e)-19-nor-9,10-secoergosta-5,7,22-triene-1alpha,3beta,25-triol

    21. Paricalcitol Solution

    22. Paricalcitol [mi]

    23. Paricalcitol [jan]

    24. (1alpha.3beta,7e,22e)-19-nor-9,10-secoergosta-5,7,22-triene-1,3,25-triol

    25. Paricalcitol [hsdb]

    26. Schembl3655

    27. Dsstox_cid_28566

    28. Dsstox_rid_82838

    29. Paricalcitol [vandf]

    30. Dsstox_gsid_48640

    31. Paricalcitol [mart.]

    32. Bidd:gt0330

    33. Paricalcitol [usp-rs]

    34. Paricalcitol [who-dd]

    35. Paricalcitol (jan/usp/inn)

    36. Gtpl2791

    37. Chembl1200622

    38. Dtxsid4048640

    39. Amy2878

    40. Bdbm233195

    41. Paricalcitol [orange Book]

    42. Paricalcitol [usp Impurity]

    43. Act07192

    44. Ex-a4434

    45. Paricalcitol [usp Monograph]

    46. Tox21_112987

    47. Lmst04030163

    48. S6681

    49. Zinc13911941

    50. Akos005145562

    51. Bcp9001050

    52. Cs-0705

    53. Db00910

    54. 19-nor-9,10-secoergosta-5,7,22-triene-1,3,25-triol, (1alpha,3beta,7e,22e)-

    55. (1r,3r)-5-(2-((1r,3as,7ar,e)-1-((2r,5s,e)-6-hydroxy-5,6-dimethylhept-3-en-2-yl)-7a-methyloctahydro-4h-inden-4-ylidene)ethylidene)cyclohexane-1,3-diol

    56. Hy-50919

    57. Cas-131918-61-1

    58. C08127

    59. D00930

    60. 918p611

    61. A937163

    62. Q155746

    63. (1.alpha.3.beta.,7e,22e)-19-nor-9,10-secoergosta-5,7,22-triene-1,3,25-triol

    64. (7e,22e)-19-nor-9,10-secoergosta-5,7,22-triene-1.alpha.,3.beta.,25-triol

    65. (1r,3r,5z)-5-[(2e)-2-[(1r,3as,7ar)-octahydro-1-[(1r,2e,4s)-5-hydroxy-1,4,5-trimethyl-2-hexen-1-yl]-7a-methyl-4h-inden-4-ylidene]ethylidene]-1,3-cyclohexanediol

    66. 1,3-cyclohexanediol, 5-[(2e)-2-[(1r,3as,7ar)-octahydro-1-[(1r,2e,4s)-5-hydroxy-1,4,5-trimethyl-2-hexen-1-yl]-7a-methyl-4h-inden-4-ylidene]ethylidene]-, (1r,3r,5z)-

    2.4 Create Date
    2005-06-24
    3 Chemical and Physical Properties
    Molecular Weight 416.6 g/mol
    Molecular Formula C27H44O3
    XLogP35
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count5
    Exact Mass416.32904526 g/mol
    Monoisotopic Mass416.32904526 g/mol
    Topological Polar Surface Area60.7 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity676
    Isotope Atom Count0
    Defined Atom Stereocenter Count7
    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 4  
    Drug NameParicalcitol
    PubMed HealthParicalcitol
    Drug ClassesAntithyroid Agent
    Drug LabelParicalcitol, USP, the active ingredient in Zemplar Injection, is a synthetically manufactured analog of calcitriol, the metabolically active form of vitamin D indicated for the prevention and treatment of secondary hyperparathyroidism associated wit...
    Active IngredientParicalcitol
    Dosage FormCapsule; Injectable
    Routeinjection; Injection; Oral
    Strength4mcg; 10mcg/ml; 0.04mcg/kg to 0.1mcg/kg; 5mcg/ml; 0.002mg/ml; 1mcg; 0.005mg/ml; 0.01mg/2ml (0.005mg/ml); 2mcg; 2mcg/ml
    Market StatusTentative Approval; Prescription
    CompanyHospira; Sandoz Canada; Teva Pharms Usa; Banner Pharmacaps; Hikma; Rising Pharms; Dr Reddys Labs

    2 of 4  
    Drug NameZemplar
    PubMed HealthParicalcitol
    Drug ClassesAntithyroid Agent
    Drug LabelParicalcitol, USP, the active ingredient in Zemplar Injection, is a synthetically manufactured analog of calcitriol, the metabolically active form of vitamin D indicated for the prevention and treatment of secondary hyperparathyroidism associated wit...
    Active IngredientParicalcitol
    Dosage FormCapsule; Injectable
    RouteInjection; Oral
    Strength4mcg; 1mcg; 0.002mg/ml; 0.005mg/ml; 2mcg
    Market StatusPrescription
    CompanyAbbvie

    3 of 4  
    Drug NameParicalcitol
    PubMed HealthParicalcitol
    Drug ClassesAntithyroid Agent
    Drug LabelParicalcitol, USP, the active ingredient in Zemplar Injection, is a synthetically manufactured analog of calcitriol, the metabolically active form of vitamin D indicated for the prevention and treatment of secondary hyperparathyroidism associated wit...
    Active IngredientParicalcitol
    Dosage FormCapsule; Injectable
    Routeinjection; Injection; Oral
    Strength4mcg; 10mcg/ml; 0.04mcg/kg to 0.1mcg/kg; 5mcg/ml; 0.002mg/ml; 1mcg; 0.005mg/ml; 0.01mg/2ml (0.005mg/ml); 2mcg; 2mcg/ml
    Market StatusTentative Approval; Prescription
    CompanyHospira; Sandoz Canada; Teva Pharms Usa; Banner Pharmacaps; Hikma; Rising Pharms; Dr Reddys Labs

    4 of 4  
    Drug NameZemplar
    PubMed HealthParicalcitol
    Drug ClassesAntithyroid Agent
    Drug LabelParicalcitol, USP, the active ingredient in Zemplar Injection, is a synthetically manufactured analog of calcitriol, the metabolically active form of vitamin D indicated for the prevention and treatment of secondary hyperparathyroidism associated wit...
    Active IngredientParicalcitol
    Dosage FormCapsule; Injectable
    RouteInjection; Oral
    Strength4mcg; 1mcg; 0.002mg/ml; 0.005mg/ml; 2mcg
    Market StatusPrescription
    CompanyAbbvie

    4.2 Therapeutic Uses

    Paricalcitol is indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4. /Included in US product labeling/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2966

    Therapeutic doses of specific vitamin D analogs are used in the treatment of chronic hypocalcemia, hypophosphatemia, rickets, and osteodystrophy associated with various medical conditions including chronic renal failure, familial hypophosphatemia, and hypoparathyroidism (postsurgical or idiopathic, or pseudohypoparathyroidism). Some analogs have been found to reduct elevated parathyroid hormone concentrations in patients with renal osteodystrophy associated with hyperparathyroidism. Theoretically, any of the vitamin D analogs may be used for the above conditions, However, because of their pharmacologic properties, some may be more useful in certain situations than others. Alfacalcidol, calcitriol, and dihydrotachysterol are usually preferred in patients with renal failure since these patients have impaired ability to synthesize calcitriol from cholecalciferol and ergocalciferol; therefore, the response is more predictable. In addition, their shorter half-lives may make toxicity easier to manage (hypercalcemia reverses more quickly). Ergocalciferol may not be the preferred agent in the treatment of familial hypophosphatemia or hypoparathyroidism because the large doses needed are associated with a risk of overdose and hypercalcemia; dihydrotachysterol and calcitriol may be preferred. /Included in US product labeling/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2966

    4.3 Drug Warning

    /Paricalcitol/ should not be given to patients with evidence of vitamin D toxicity, hypercalcemia, or hypersensitivity to any ingredient in this product.

    Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 538

    Doses of vitamin D analogs that do not exceed the physiologic requirement are usually nontoxic. However, some infants and patients with sarcoidosis or hypoparathyroidism may have increased sensitivity to vitamin D analogs. /Vitamin D analogs/

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3541

    Acute or chronic administration of excessive doses of vitamin D analogs or enhanced responsiveness to physiologic amounts of ergocalciferol or cholecalciferol may lead to hypervitaminosis D manifested by hypercalcemia. /Vitamin D analogs/

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3541

    Decreased renal function without hypercalcemia has also been reported in patients with hypoparathyroidism after long-term vitamin D analog therapy. Before therapy with vitamin D analogs is initiated, serum phosphate concentrations must be controlled. To avoid ectopic calcification, the serum calcium (in mg/dL) times phosphorus (in mg/dL) should not be allowed to exceed 70. Because administration of vitamin D analogs may increase phosphate absorption, patients with renal failure may require adjustment in the dosage of aluminum-containing antacids used to decrease phosphate absorption. /Vitamin D analogs/

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3541

    For more Drug Warnings (Complete) data for PARICALCITOL (8 total), please visit the HSDB record page.

    4.4 Drug Indication

    For treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) Stage 3 and 4

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Secondary hyperparathyroidism is characterized by an elevation in parathyroid hormone (PTH) associated with inadequate levels of active vitamin D hormone. The source of vitamin D in the body is from synthesis in the skin and from dietary intake. Vitamin D requires two sequential hydroxylations in the liver and the kidney to bind to and to activate the vitamin D receptor (VDR). The endogenous VDR activator, calcitriol [1,25(OH)2 D3], is a hormone that binds to VDRs that are present in the parathyroid gland, intestine, kidney, and bone to maintain parathyroid function and calcium and phosphorus homeostasis, and to VDRs found in many other tissues, including prostate, endothelium and immune cells. VDR activation is essential for the proper formation and maintenance of normal bone. In the diseased kidney, the activation of vitamin D is diminished, resulting in a rise of PTH, subsequently leading to secondary hyperparathyroidism and disturbances in the calcium and phosphorus homeostasis.1 Decreased levels of 1,25(OH)2 D3 have been observed in early stages of chronic kidney disease. The decreased levels of 1,25(OH)2 D3 and resultant elevated PTH levels, both of which often precede abnormalities in serum calcium and phosphorus, affect bone turnover rate and may result in renal osteodystrophy. An in vitro study indicates that paricalcitol is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A at concentrations up to 50 nM (21 ng/mL).

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    PARICALCITOL
    5.2.2 FDA UNII
    6702D36OG5
    5.2.3 Pharmacological Classes
    Vitamin D2 Analog [EPC]; Vitamin D3 Analog [EPC]; Cholecalciferol [CS]; Ergocalciferols [CS]
    5.3 ATC Code

    H - Systemic hormonal preparations, excl. sex hormones and insulins

    H05 - Calcium homeostasis

    H05B - Anti-parathyroid agents

    H05BX - Other anti-parathyroid agents

    H05BX02 - Paricalcitol

    5.4 Absorption, Distribution and Excretion

    Absorption

    Well absorbed

    Route of Elimination

    Paricalcitol is excreted primarily by hepatobiliary excretion.

    Volume of Distribution

    30.8 7.5 L [CKD Stage 5-HD]

    34.9 9.5 L [CKD Stage 5-PD]

    23.8 L [healthy subjects]

    Clearance

    1.49 +/- 0.60 L/h [chronic kidney disease Stage 5 with hemodialysis]

    1.54 +/- 0.95 L/h [chronic kidney disease Stage 5with peritoneal dialysis]

    Stored mainly in liver and other fat depots. /Vitamin D and analogs/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2967

    Many vitamin D analogs are readily absorbed from the GI tract following oral administration if fat absorption is normal. The presence of bile is required for absorption of ergocalciferol and the extent of GI absorption may be decreased in patients with hepatic, biliary, or GI disease (e.g., Crohn's disease, Whipple's disease, sprue). Because vitamin D is fat soluble, it is incorporated into chylomicrons and absorbed via the lymphatic system; approximately 80% of ingested vitamin D appears to be absorbed systemically through this mechanism, principally in the small intestine. Although some evidence suggested that intestinal absorption of vitamin D may be decreased in geriatric adults, other evidence did not show clinically important age-related alterations in GI absorption of the vitamin in therapeutic doses. It currently is not known whether aging alters the GI absorption of physiologic amounts of vitamin D. /Vitamin D analogs/

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3543

    It is not known whether paricalcitol ... is excreted in human milk.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2967

    In healthy subjects, plasma radioactivity after a single 0.16 mg/kg intravenous bolus dose of 3H-paricalcitol (n=4) was attributed to parent drug. Paricalcitol was eliminated primarily by hepatobiliary excretion, as 74% of the radioactive dose was recovered in feces and only 16% was found in urine.

    Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 538

    For more Absorption, Distribution and Excretion (Complete) data for PARICALCITOL (7 total), please visit the HSDB record page.

    5.5 Metabolism/Metabolites

    Metabolized by multiple hepatic and non-hepatic enzymes, including mitochondrial CYP24, as well as CYP3A4 and UGT1A4

    After oral administration of a 0.48 mcg/kg dose of 3 H-paricalcitol, parent drug was extensively metabolized, with only about 2% of the dose eliminated unchanged in the feces, and no parent drug found in the urine. Several metabolites were detected in both the urine and feces. Most of the systemic exposure was from the parent drug. Two minor metabolites, relative to paricalcitol, were detected in human plasma. One metabolite was identified as 24(R)-hydroxy paricalcitol, while the other metabolite was unidentified. The 24(R)-hydroxy paricalcitol is less active than paricalcitol in an in vivo rat model of PTH suppression.

    Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 536

    In vitro data suggest that paricalcitol is metabolized by multiple hepatic and non-hepatic enzymes, including mitochondrial CYP24, as well as CYP3A4 and UGT1A4. The identified metabolites include the product of 24(R)-hydroxylation, 24,26- and 24,28-dihydroxylation and direct glucuronidation.

    Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 536

    5.6 Biological Half-Life

    4 to 6 hours

    In healthy subjects, the mean elimination half-life of paricalcitol is 4 to 6 hours over the studied dose range of 0.06 to 0.48 mcg/kg. The pharmacokinetics of paricalcitol capsule have been studied in patients with chronic kidney disease (CKD) Stage 3 and 4 patients. After administration of 4 mcg paricalcitol capsule in CKD Stage 3 patients, the mean elimination half-life of paricalcitol is 17 hours. The mean half-life of paricalcitol is 20 hours in CKD Stage 4 patients when given 3 mcg of paricalcitol capsule.

    Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 536

    Plasma half-life: 15 hours.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2967

    5.7 Mechanism of Action

    Paricalcitol is a synthetic, biologically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Preclinical andin vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the VDR, which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.

    Paricalcitol is a synthetic, biologically active vitamin D analog of calcitriol with modifications to the side chain (D2) and the A (19-nor) ring. Preclinical and in vitro studies have demonstrated that paricalcitol's biological actions are mediated through binding of the vitamin D receptor (VDR), which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.

    Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 536

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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23895

    Submission : 2010-06-18

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCarrow-down
    ✖

    Date of Issue : 2022-07-28

    Valid Till : 2025-06-16

    Written Confirmation Number : WC-0036

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 58032-1001

    Start Marketing Date : 2017-12-14

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    Neuland

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    05

    TAPI Technology & API Services

    Israel

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPhI WW Frankfurt
    Booth #6.1A32
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

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    Digital Content Digital Content
    USDMF arrow-down
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    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-23

    Pay. Date : 2012-11-13

    DMF Number : 20865

    Submission : 2007-09-19

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF ASMF arrow-down
    ✖
    Available Reg Filing : ASMF
    AUDIT
    TAPI Company Banner

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    06

    Sai Life Sciences Limited

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    CPHI Middle east
    Not Confirmed
    arrow

    Sai Life Sciences Limited

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPHI Middle east
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2014-09-09

    Pay. Date : 2012-11-21

    DMF Number : 26545

    Submission : 2012-11-14

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 14474-021

    Start Marketing Date : 2008-01-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (25kg/25kg)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    07

    Formosa Laboratories

    Taiwan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    CPHI Middle east
    Not Confirmed
    arrow

    Formosa Laboratories

    Taiwan

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPHI Middle east
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2012-11-08

    Pay. Date : 2012-11-23

    DMF Number : 21880

    Submission : 2008-08-14

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 66499-0019

    Start Marketing Date : 2008-01-16

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

     KDMF arrow-down
    ✖

    Registrant Name : Kisan Pharmaceutical Co., Ltd.

    Registration Date : 2018-04-27

    Registration Number : 20151218-198-I-467-04(1)

    Manufacturer Name : Formosa Laboratories, Inc. Louchu Plant

    Manufacturer Address : 36, Hoping Street, Louchu, Taoyuan 33842, Taiwan

     VMF Others AUDIT
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    08

    Chongqing Huapont Pharmaceutical

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    CPHI Middle east
    Not Confirmed
    arrow

    Chongqing Huapont Pharmaceutical

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPHI Middle east
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28550

    Submission : 2014-07-30

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 48943-0033

    Start Marketing Date : 2022-01-14

    End Marketing Date : 2025-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
    blank

    Portfolio PDF

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    Digital Content

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    Corporate PDF

    09

    DISHMAN NETHERLANDS B.V.

    Netherlands

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    CPHI Middle east
    Not Confirmed
    arrow

    DISHMAN NETHERLANDS B.V.

    Netherlands

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPHI Middle east
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25300

    Submission : 2011-09-13

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    Nanjing Heron Pharmaceutical

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    CPHI Middle east
    Not Confirmed
    arrow

    Nanjing Heron Pharmaceutical

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    CPHI Middle east
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38269

    Submission : 2023-08-04

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
    blank

    Portfolio PDF

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    Listed Suppliers

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    01

    LGM Pharma

    U.S.A
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Paricalcitol

    About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

    LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
    LGM Pharma CB

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    02

    Rochem International Inc

    U.S.A
    arrow
    Suppliers Night Expo
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Paricalcitol

    About the Company : Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quali...

    Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.
    Rochem

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    03

    TAPI Technology & API Services

    Israel
    arrow
    CPhI WW Frankfurt
    Booth #6.1A32
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTAPI offers customized CDMO Solutions for API development and manufacturing services.

    Contact Supplier Contact Supplier
    Flag Israel
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Paricalcitol

    About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

    Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
    TAPI Company Banner

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    Corporate PDF

    04

    Chongqing Huapont Pharmaceutical

    China
    CPHI Middle east
    Not Confirmed
    arrow

    Chongqing Huapont Pharmaceutical

    China
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth 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.
    Post an Enquiry Post an Enquiry
    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Paricalcitol

    About the Company : Chongqing Huapont Pharmaceutical Co., Ltd. was established in 1994 and is now located in Liangjiang New District, Chongqing. It is a national high-tech enterprise, a national innov...

    Chongqing Huapont Pharmaceutical Co., Ltd. was established in 1994 and is now located in Liangjiang New District, Chongqing. It is a national high-tech enterprise, a national innovative enterprise, and a national demonstration enterprise for a new model of intelligent manufacturing. It has a national enterprise technology center and multiple municipal R&D platforms, two formulation factories, and two API factories. In addition, the company is also widely involved in the fields of respiratory, cardiovascular and cerebrovascular, blood, tumor, and systemic hormones, and has accumulated a large number of blockbuster drugs.
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    05

    DISHMAN NETHERLANDS B.V.

    Netherlands
    CPHI Middle east
    Not Confirmed
    arrow

    DISHMAN NETHERLANDS B.V.

    Netherlands
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth 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.
    Post an Enquiry Post an Enquiry
    Flag Netherlands
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Paricalcitol

    About the Company : DISHMAN Netherlands is located in Veenendaal in the middle of the Netherlands. We are active in the marketing/sales and manufacture of Vitamin D analogues, Vitamin D, Cholesterol a...

    DISHMAN Netherlands is located in Veenendaal in the middle of the Netherlands. We are active in the marketing/sales and manufacture of Vitamin D analogues, Vitamin D, Cholesterol and lanolin related products for key markets as pharmaceutical, cosmetic, feed, food, shrimp farming and industry applications. Our Vitamin D analogue products include: Alfacalcidol, Calcifediol, Calcitriol, & Dihydrotachysterol-2. These analogues are used in pharmaceutical products to combat Osteoporosis, rickets etc. Vitamin D2 and D3 are manufactured for use in the food, feed and pharmaceutical industries. Cholesterol is used in diverse applications such as drug d
    blank

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    06

    DongWha Pharm

    South Korea
    CPHI Middle east
    Not Confirmed
    arrow

    DongWha Pharm

    South Korea
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth 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.
    Post an Enquiry Post an Enquiry
    Flag South Korea
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Paricalcitol

    About the Company : DongWha is the company that "serves customers by making good medicines and is managed with the rewards generated by benefits of good medicines." Under its corporate philosophy that...

    DongWha is the company that "serves customers by making good medicines and is managed with the rewards generated by benefits of good medicines." Under its corporate philosophy that places the foremost priority on health and safety of its customers, it continues to work toward happiness of customers. Based on respect for the shared value that "we work diligently in our youth and live fruitful lives in old age." it serves every customer faithfully by fostering ownership and faith among its members.
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    07

    Hanways Chempharm

    China
    CPHI Middle east
    Not Confirmed
    arrow

    Hanways Chempharm

    China
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth 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.
    Post an Enquiry Post an Enquiry
    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Paricalcitol

    About the Company : Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediate...

    Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediates, and fine chemicals for worldwide markets. With decades of development, now we grow to a leading and outstanding company. We are not just a trading company, but a comprehensive solutions supplier. With our sound knowledge of pharmaceutical business, our advantage is to integrate resources and adapt to all different demands of markets. We are a young but dynamic and energetic company with high efficient and high flexible decision making system.
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    08

    Haoyuan Chemexpress Co.Ltd

    China
    CPHI Middle east
    Not Confirmed
    arrow

    Haoyuan Chemexpress Co.Ltd

    China
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth 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.
    Post an Enquiry Post an Enquiry
    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Paricalcitol

    About the Company : Haoyuan Chemexpress Co., Ltd., located in Shanghai Zhangjiang Biomedical Base, is a high-tech company specializing in customized chemical synthesis and R&D of pharmaceutical interm...

    Haoyuan Chemexpress Co., Ltd., located in Shanghai Zhangjiang Biomedical Base, is a high-tech company specializing in customized chemical synthesis and R&D of pharmaceutical intermediates and new drugs. The company is mainly engaged in customized synthesis of complex small molecule frameworks and pharmaceutical intermediates, and independent R&D of innovative new drugs; and provides services of production technology improvement and consigned new drug development for pharmaceutical enterprises. Haoyuan Chemexpress is committed to researching and developing APIs and pharmaceutical intermediates with high synthesis technology barriers and difficulties and high added value, and also focuses on the synthesis of chiral compounds.
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    09

    Sichuan Gowell Pharmaceutical

    China
    CPHI Middle east
    Not Confirmed
    arrow

    Sichuan Gowell Pharmaceutical

    China
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth 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.
    Post an Enquiry Post an Enquiry
    Flag China
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Paricalcitol

    About the Company : Guowei Pharmaceutical was established in 2005 and is headquartered in Chengdu High-tech Zone. Its subsidiaries include Chengdu Guowei Biopharmaceutical Co., Ltd., Sichuan Guowei Ph...

    Guowei Pharmaceutical was established in 2005 and is headquartered in Chengdu High-tech Zone. Its subsidiaries include Chengdu Guowei Biopharmaceutical Co., Ltd., Sichuan Guowei Pharmaceutical Co., Ltd., and Shanghai Ocuen Biotechnology Co., Ltd. After years of development, Guowei Pharmaceutical has developed into a comprehensive pharmaceutical enterprise integrating R&D, production, and sales. Guowei Pharmaceutical's research and development and sales of products are mainly concentrated in the fields of cardiovascular and cerebrovascular, digestive system, anti-infection, and urinary system.
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    10

    Teva Pharmaceutical Industries

    Israel
    CPHI Middle east
    Not Confirmed
    arrow

    Teva Pharmaceutical Industries

    Israel
    arrow
    CPHI Middle east
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth 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.
    Post an Enquiry Post an Enquiry
    Flag Israel
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Paricalcitol

    About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and...

    Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a year at 70 manufacturing facilities. We rank among the leading pharmaceutical companies in the world and are active in 60 countries. Approximately 43,000 employees around the world are dedicated to our mission. Building on our strong global footprint, size and scale, Teva is reaffirming its commitment to place people at the center of our strategy, and enable as many as possible to live better, healthier days.
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    API Reference Price

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    [{"dataSource":"API Export","activeIngredients":"PARICALCITOL","year":"2021","qtr":"Q1","strtotime":1611340200,"product":"PARICALCITOL USP","address":"FLAT NO.204,IIND FLOOR,MERIDIANPLAZA,6-3-853\/1,AMEERPET,","city":"HYDERABAD-ANDHRA PRADESH.","supplier":"NEULAND LABORATORIES","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"RAFARM S.A","customerCountry":"GREECE","quantity":"0.00","actualQuantity":"2.2","unit":"GMS","unitRateFc":"9736.7","totalValueFC":"21688.1","currency":"USD","unitRateINR":720999.99999999988,"date":"23-Jan-2021","totalValueINR":"1586200","totalValueInUsd":"21688.1","indian_port":"HYDERABAD AIR","hs_no":"29055900","bill_no":"8114666","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"FLAT NO.204,IIND FLOOR,MERIDIANPLAZA,6-3-853\/1,AMEERPET,, HYDERABAD-ANDHRA PRADESH.","customerAddress":""},{"dataSource":"API 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    23-Jan-2021
    24-Sep-2024
    KGS
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    DOSAGE - CAPSULE;ORAL - 1MCG

    USFDA APPLICATION NUMBER - 21606

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    USFDA APPLICATION NUMBER - 21606

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    DOSAGE - CAPSULE;ORAL - 4MCG **Federal Regist...DOSAGE - CAPSULE;ORAL - 4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 21606

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