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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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    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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    USDMF arrow-down
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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23895

    Submission : 2010-06-18

    Status : Active

    Type : II

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

    NDC Package Code : 58032-1001

    Start Marketing Date : 2017-12-14

    End Marketing Date : 2025-12-31

    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

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    FCE Pharma
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content
    USDMF arrow-down
    ✖

    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

    Formosa Laboratories

    Taiwan

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

    Peptide Forum
    Not Confirmed
    arrow

    Formosa Laboratories

    Taiwan

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

    arrow
    Peptide Forum
    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 : 2025-12-31

    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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    07

    Nanjing Heron Pharmaceutical

    China

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

    Peptide Forum
    Not Confirmed
    arrow

    Nanjing Heron Pharmaceutical

    China

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

    arrow
    Peptide Forum
    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
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    08

    Sai Life Sciences Limited

    India

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

    Peptide Forum
    Not Confirmed
    arrow

    Sai Life Sciences Limited

    India

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

    arrow
    Peptide Forum
    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 : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

     KDMF VMF Others AUDIT
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    09

    Chongqing Huapont Pharmaceutical

    China

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

    Peptide Forum
    Not Confirmed
    arrow

    Chongqing Huapont Pharmaceutical

    China

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

    arrow
    Peptide Forum
    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

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    10

    DISHMAN NETHERLANDS B.V.

    Netherlands

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

    Peptide Forum
    Not Confirmed
    arrow

    DISHMAN NETHERLANDS B.V.

    Netherlands

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

    arrow
    Peptide Forum
    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
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    USDMF

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    01

    Abbvie Inc

    U.S.A
    arrow
    The Battery Show Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 24315

    Submission : 2010-11-30

    Status : Active

    Type : II

    Abbvie Company Banner

    Portfolio PDF

    Product Web Link

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    Digital Content

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    Corporate PDF

    02

    Neuland Laboratories Ltd

    India
    arrow
    CPhI WW Frankfurt
    Booth #6.1D6
    • fda
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    • WHO-GMP

    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 23895

    Submission : 2010-06-18

    Status : Active

    Type : II

    Neuland

    Portfolio PDF

    Product Web Link

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    03

    Teva Pharmaceutical Industries Ltd

    Israel
    arrow
    Chemspec Europe
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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    Flag Israel
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-23

    Pay. Date : 2012-11-13

    DMF Number : 20865

    Submission : 2007-09-19

    Status : Active

    Type : II

    TAPI Company Banner

    Portfolio PDF

    Product Web Link

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    Digital Content

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    Corporate PDF

    04

    The Battery Show Europe
    Not Confirmed

    04

    Alp Pharm Beijing Co Ltd

    China
    arrow
    The Battery Show Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 21255

    Submission : 2008-01-16

    Status : Active

    Type : II

    blank

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    05

    The Battery Show Europe
    Not Confirmed

    05

    Catalent Pharma Solutions Llc

    U.S.A
    arrow
    The Battery Show Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17386

    Submission : 2004-05-20

    Status : Inactive

    Type : II

    blank

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    06

    The Battery Show Europe
    Not Confirmed

    06

    Catalent Pharma Solutions Llc

    U.S.A
    arrow
    The Battery Show Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 16402

    Submission : 2003-02-03

    Status : Inactive

    Type : II

    blank

    Portfolio PDF

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    07

    The Battery Show Europe
    Not Confirmed

    07

    Chongqing Huapont Pharmaceutical Co ...

    China
    arrow
    The Battery Show Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28550

    Submission : 2014-07-30

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    Corporate PDF

    08

    Dishman Netherlands Bv

    Netherlands

    USDMF

    arrow
    The Battery Show Europe
    Not Confirmed

    08

    Dishman Netherlands Bv

    Netherlands
    arrow
    The Battery Show Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 25300

    Submission : 2011-09-13

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    09

    The Battery Show Europe
    Not Confirmed

    09

    Formosa Laboratories Inc

    Taiwan
    arrow
    The Battery Show Europe
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2012-11-08

    Pay. Date : 2012-11-23

    DMF Number : 21880

    Submission : 2008-08-14

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    Sai Life Sciences Ltd

    India

    USDMF

    arrow
    The Battery Show Europe
    Not Confirmed

    10

    Sai Life Sciences Ltd

    India
    arrow
    The Battery Show Europe
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2014-09-09

    Pay. Date : 2012-11-21

    DMF Number : 26545

    Submission : 2012-11-14

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    KDMF

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    01

    ACS DOBFAR SPA

    Italy
    Europ. Pharma Outsourcing
    Not Confirmed
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    ACS DOBFAR SPA

    Italy
    arrow
    Europ. Pharma Outsourcing
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    paricalcitol

    Registrant Name : AbbVie Korea Inc.

    Registration Date : 2013-05-03

    Registration Number : 20130503-198-I-121-02

    Manufacturer Name : AbbVie Ireland NL BV

    Manufacturer Address : Manorhamilton Road, Sligo, Ireland

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    Product Web Link

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    02

    Assia Chemical Industries Ltd

    Israel
    Europ. Pharma Outsourcing
    Not Confirmed
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    Assia Chemical Industries Ltd

    Israel
    arrow
    Europ. Pharma Outsourcing
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
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    paricalcitol

    Registrant Name : Samoh Pharmaceutical Co., Ltd.

    Registration Date : 2014-10-22

    Registration Number : 20141022-198-I-434-03

    Manufacturer Name : Assia Chemical Industries Lt...

    Manufacturer Address : Neot Hovav Eco-Industrial Park, Emek Sara, POBox 2049, Be'er Sheva 8412316, Israel

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    03

    Formosa Laboratories

    Taiwan
    Europ. Pharma Outsourcing
    Not Confirmed
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    Formosa Laboratories

    Taiwan
    arrow
    Europ. Pharma Outsourcing
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    paricalcitol

    Registrant Name : Kisan Pharmaceutical Co., Ltd.

    Registration Date : 2018-04-27

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

    Manufacturer Name : Formosa Laboratories, Inc. L...

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

    blank

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    Product Web Link

    Virtual Booth

    Digital Content

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    04

    Formosa Laboratories

    Taiwan
    Europ. Pharma Outsourcing
    Not Confirmed
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    Formosa Laboratories

    Taiwan
    arrow
    Europ. Pharma Outsourcing
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    paricalcitol

    Registrant Name : Pami Future Co., Ltd.

    Registration Date : 2015-12-18

    Registration Number : 20151218-198-I-467-04

    Manufacturer Name : Formosa Laboratories, Inc.

    Manufacturer Address : 36 Hoping Street, Louchu, Taoyuan 338002, Taiwan

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    05

    Sagami Chemical Industry

    Japan
    Europ. Pharma Outsourcing
    Not Confirmed
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    Sagami Chemical Industry

    Japan
    arrow
    Europ. Pharma Outsourcing
    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.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    paricalcitol

    Registrant Name : AbbVie Korea Inc.

    Registration Date : 2013-02-15

    Registration Number : 20130215-198-I-122-01

    Manufacturer Name : SAFC Inc.

    Manufacturer Address : 645 Science Drive Madison WI 53711

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    06

    Europ. Pharma Outsourcing
    Not Confirmed
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    Europ. Pharma Outsourcing
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    paricalcitol

    Registrant Name : (주)와이에스생명과학

    Registration Date : 2025-02-20

    Registration Number : 20250220-198-I-699-05

    Manufacturer Name : (주)와이에스생명과...

    Manufacturer Address : 경기도 화성시 장안면 수정로 207

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    NDC API

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    01

    AbbVie Ireland NL B.V.

    U.S.A
    arrow
    Peptide Forum
    Not Confirmed
    • fda
    • EDQM
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    PARICALCITOL

    NDC Package Code : 68513-1054

    Start Marketing Date : 2011-09-30

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    Abbvie Company Banner

    Portfolio PDF

    Product Web Link

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    Digital Content

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    02

    Neuland Laboratories Limited

    India
    arrow
    CPhI WW Frankfurt
    Booth #6.1D6
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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    PARICALCITOL

    NDC Package Code : 58032-1001

    Start Marketing Date : 2017-12-14

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

    Neuland

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    03

    Chongqing Huapont Pharmaceutical Co...

    China
    Peptide Forum
    Not Confirmed
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    Chongqing Huapont Pharmaceutical Co...

    China
    arrow
    Peptide Forum
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    PARICALCITOL

    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

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    04

    Formosa Laboratories, Inc.

    Taiwan
    Peptide Forum
    Not Confirmed
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    Formosa Laboratories, Inc.

    Taiwan
    arrow
    Peptide Forum
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    PARICALCITOL

    NDC Package Code : 66499-0019

    Start Marketing Date : 2008-01-16

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    05

    Sai Life Sciences Limited

    India
    Peptide Forum
    Not Confirmed
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    Sai Life Sciences Limited

    India
    arrow
    Peptide Forum
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
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    Digital Content Digital Content

    PARICALCITOL

    NDC Package Code : 14474-021

    Start Marketing Date : 2008-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    06

    Sigma-Aldrich Corporation

    U.S.A
    Peptide Forum
    Not Confirmed
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    Sigma-Aldrich Corporation

    U.S.A
    arrow
    Peptide Forum
    Not Confirmed
    • fda
    • EDQM
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    PARICALCITOL

    NDC Package Code : 58272-192

    Start Marketing Date : 2000-01-01

    End Marketing Date : 2025-12-31

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

    Marketing Category : BULK INGREDIENT

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    API Reference Price

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    01-Feb-2022
    31-Jan-2025
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    DOSAGE - CAPSULE;ORAL - 1MCG

    USFDA APPLICATION NUMBER - 21606

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    DOSAGE - CAPSULE;ORAL - 2MCG

    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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    ABOUT THIS PAGE

    Looking for 131918-61-1 / Paricalcitol API manufacturers, exporters & distributors?

    Paricalcitol manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Paricalcitol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Paricalcitol manufacturer or Paricalcitol supplier for your needs.

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    PharmaCompass also assists you with knowing the Paricalcitol API Price utilized in the formulation of products. Paricalcitol API Price is not always fixed or binding as the Paricalcitol Price is obtained through a variety of data sources. The Paricalcitol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Paricalcitol

    Synonyms

    131918-61-1, Zemplar, Compound 49510, 19-nor-1alpha,25-dihydroxyvitamin d2, Paracalcin, Compound-49510

    Cas Number

    131918-61-1

    Unique Ingredient Identifier (UNII)

    6702D36OG5

    About 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)

    131918-61-1 Manufacturers

    A 131918-61-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 131918-61-1, including repackagers and relabelers. The FDA regulates 131918-61-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 131918-61-1 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 131918-61-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    131918-61-1 Suppliers

    A 131918-61-1 supplier is an individual or a company that provides 131918-61-1 active pharmaceutical ingredient (API) or 131918-61-1 finished formulations upon request. The 131918-61-1 suppliers may include 131918-61-1 API manufacturers, exporters, distributors and traders.

    click here to find a list of 131918-61-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    131918-61-1 USDMF

    A 131918-61-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of 131918-61-1 active pharmaceutical ingredient (API) in detail. Different forms of 131918-61-1 DMFs exist exist since differing nations have different regulations, such as 131918-61-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A 131918-61-1 DMF submitted to regulatory agencies in the US is known as a USDMF. 131918-61-1 USDMF includes data on 131918-61-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 131918-61-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of 131918-61-1 suppliers with USDMF on PharmaCompass.

    131918-61-1 KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a 131918-61-1 Drug Master File in Korea (131918-61-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 131918-61-1. The MFDS reviews the 131918-61-1 KDMF as part of the drug registration process and uses the information provided in the 131918-61-1 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a 131918-61-1 KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their 131918-61-1 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of 131918-61-1 suppliers with KDMF on PharmaCompass.

    131918-61-1 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 131918-61-1 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for 131918-61-1 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 131918-61-1 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 131918-61-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 131918-61-1 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of 131918-61-1 suppliers with NDC on PharmaCompass.

    131918-61-1 GMP

    131918-61-1 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 131918-61-1 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 131918-61-1 GMP manufacturer or 131918-61-1 GMP API supplier for your needs.

    131918-61-1 CoA

    A 131918-61-1 CoA (Certificate of Analysis) is a formal document that attests to 131918-61-1's compliance with 131918-61-1 specifications and serves as a tool for batch-level quality control.

    131918-61-1 CoA mostly includes findings from lab analyses of a specific batch. For each 131918-61-1 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.

    131918-61-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (131918-61-1 EP), 131918-61-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (131918-61-1 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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