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1. Azd 2281
2. Azd-2281
3. Azd221
4. Azd2281
5. Lynparza
1. 763113-22-0
2. Lynparza
3. Azd2281
4. Azd-2281
5. Ku-0059436
6. Azd 2281
7. 1-(cyclopropylcarbonyl)-4-[5-[(3,4-dihydro-4-oxo-1-phthalazinyl)methyl]-2-fluorobenzoyl]piperazine
8. Olaparib (azd-2281)
9. 4-(3-(4-(cyclopropanecarbonyl)piperazine-1-carbonyl)-4-fluorobenzyl)phthalazin-1(2h)-one
10. Ku-59436
11. Olaparib (azd2281, Ku-0059436)
12. 4-[[3-[4-(cyclopropanecarbonyl)piperazine-1-carbonyl]-4-fluorophenyl]methyl]-2h-phthalazin-1-one
13. Az2281
14. Mfcd13185161
15. Woh1jd9ar8
16. Nsc-747856
17. C24h23fn4o3
18. Chebi:83766
19. 4-(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorobenzyl)phthalazin-1(2h)-one
20. 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2h-phthalazin-1-one
21. Az-2281
22. Keylynk-010 Component Olaparib
23. Ku59436
24. Olaparib Component Of Keylynk-010
25. Olaparib [inn]
26. Olaparib Cpd
27. Olaparib (azd2281; Ku-0059436)
28. Olaparib [usan:inn]
29. Unii-woh1jd9ar8
30. Olaparib (azd2281)
31. Acylpiperazine Analogue, 47
32. Olaparibum
33. Azd221
34. 4-[3-[4-(cyclopropanecarbonyl)piperazine-1-carbonyl]-4-fluorobenzyl]phthalazin-1(2h)-one
35. Olaparib- Bio-x
36. Lynparza (tn)
37. 09l
38. 4-((3-((4-(cyclopropylcarbonyl)piperazin-1-yl)carbonyl)-4-fluorophenyl)methyl)phthalazin-1(2h)-one
39. 4-((3-{(4-(cyclopropylcarbonyl)piperazin-1-yl)carbonyl}-4-fluorophenyl)methyl)phthalazin-1(2h)-one
40. 4-[(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorophenyl)methyl]phthalazin-1(2h)-one
41. Ku 59436
42. Olaparib [usan]
43. Olaparib [jan]
44. Ku0059436
45. Olaparib [mi]
46. Olaparib [vandf]
47. Olaparib - Azd2281
48. Olaparib [mart.]
49. Olaparib [who-dd]
50. Azd-2281 (olaparib)
51. Olaparib (jan/usan/inn)
52. Mls006010185
53. Schembl426568
54. Olaparib [orange Book]
55. Chembl521686
56. Gtpl7519
57. Bdbm27566
58. Dtxsid60917988
59. Ex-a002
60. Bcpp000360
61. Hms3295i09
62. Hms3426c03
63. Hms3654g13
64. Hms3746k07
65. Hms3870h03
66. Amy10295
67. Bcp01872
68. 763113-22-0, Lynparza,
69. Nsc747856
70. Nsc753686
71. S1060
72. Zinc40430143
73. Akos005145764
74. Ac-7939
75. Bcp9000363
76. Ccg-264799
77. Cs-0075
78. Db09074
79. Ex-7210
80. Nsc 747856
81. Nsc-753686
82. Sb14617
83. Ss-4573
84. Azd2281,olaparib, Ku-0059436
85. Ncgc00238451-01
86. Ncgc00238451-02
87. Ncgc00238451-08
88. Ncgc00238451-09
89. Ncgc00238451-11
90. 4-[(3-{[4-cyclopropylcarbonyl)piperazin-4-yl]carbonyl}-4-fluorophenyl)methyl]phtalazin-1(2h)-one
91. 4-[[3-[[4-(cyclopropylcarbonyl)-1-piperazinyl]carbonyl]-4-fluorophenyl]methyl]-1(2h)-phthalazinone
92. Bo164169
93. Hy-10162
94. Smr004701291
95. Sy040527
96. Olaparib(azd2281,kudosku-0059436)
97. A9666
98. Bb 0260909
99. Ft-0651458
100. Ku 0059436
101. Sw218142-2
102. Ec-000.2324
103. D09730
104. J-503540
105. Q7083106
106. Brd-k02113016-001-08-9
107. Brd-k02113016-001-09-7
108. 1-(cyclopropylcarbonyl)-4-[5-[(3,4-dihydro-4-oxo-1-phthalazine
109. 4-(3-(1-(cyclopropanecarbonyl)piperazine-4-carbonyl)-4-fluorobenzyl)phthalazin-1(2h)-one
110. (2h)-phthalazinone, 4-((3-((4-(cyclopropylcarbonyl)-1-piperazinyl)carbonyl)-4-fluorophenyl)methyl)-
111. 1(2h)-phthalazinone, 4-((3-((4-(cyclopropylcarbonyl)-1-piperazinyl)carbonyl)-4-fluorophenyl)methyl)-
112. 1021843-02-6
113. 4-({3-[(4-cyclopropanecarbonylpiperazin-1-yl)carbonyl]-4-fluorophenyl}methyl)-1,2-dihydrophthalazin-1-one
114. Piperazine, 1-(cyclopropylcarbonyl)-4-(5-((3,4-dihydro-4-oxo-1-phthalazinyl)methyl)-2-fluorobenzoyl)-
Molecular Weight | 434.5 g/mol |
---|---|
Molecular Formula | C24H23FN4O3 |
XLogP3 | 1.9 |
Hydrogen Bond Donor Count | 1 |
Hydrogen Bond Acceptor Count | 5 |
Rotatable Bond Count | 4 |
Exact Mass | 434.17541877 g/mol |
Monoisotopic Mass | 434.17541877 g/mol |
Topological Polar Surface Area | 82.1 Ų |
Heavy Atom Count | 32 |
Formal Charge | 0 |
Complexity | 790 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of: - Ovarian cancer, in which the medication is intended for [a] the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy, or [b] for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for olaparib. - Breast cancer, in which the medication is intended for use in patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment. Select patients for therapy based on an FDA-approved companion diagnostic for olaparib.
FDA Label
* Ovarian cancer :
Lynparza is indicated as monotherapy for the:
- maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.
- maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.
Lynparza in combination with bevacizumab is indicated for the:
- maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5. 1).
* Breast cancer :
Lynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer . Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5. 1).
Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.
* Adenocarcinoma of the pancreas:
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.
* Prostate cancer :
Lynparza is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.
Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum based chemotherapy.
The effect of olaparib on cardiac repolarization was assessed in 119 patients following a single dose of 300 mg and in 109 patients following multiple dosing of 300 mg twice daily. No clinically relevant effect of olaparib on QT interval was observed.
Antineoplastic Agents
Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)
Poly(ADP-ribose) Polymerase Inhibitors
Chemicals and drugs that inhibit the action of POLY(ADP-RIBOSE)POLYMERASES. (See all compounds classified as Poly(ADP-ribose) Polymerase Inhibitors.)
L01XK01
L - Antineoplastic and immunomodulating agents
L01 - Antineoplastic agents
L01X - Other antineoplastic agents
L01XK - Poly (adp-ribose) polymerase (parp) inhibitors
L01XK01 - Olaparib
Absorption
Following oral administration, the absorption of olaparib is very rapid and can reach a peak concentration ranging between 4.7 and 9.1 mcg/ml after 1-3 hours. The reported AUC of olaparib after a dose of 200 mg is of 25.8 mcg.h/L and this AUC can be increased by 26% with constant administration. The consumption of a high-fat diet with olaparib can only decrease the tmax but do not have an effect in the peak concentration.
Route of Elimination
From the administered dose, approximately 86% of the administered dose is recovered after 7 days from which 44% is found in the urine and 42% is obtained in feces.
Volume of Distribution
After administration of a dose of 100 mg/kg, the reported volume of distribution was of 40.3 L.
Clearance
The total clearance of olaparib was reported to be 4.6 L/h.
Olaparib is extensively metabolized in the liver by the action of CYP3A isoenzymes. From the administered dose, the unchanged form of olaparib accounted for 70% of the circulating dose and it was considered the major component in urine and feces. The metabolic pathway of olaparib is mainly attributable to oxidation reactions with subsequent glucuronide and sulfate conjugation. However, the over 20 metabolites found in plasma, urine, and feces represented a minor portion of the administered dose. The major circulating metabolites were represented by the mono-oxygenated form and the piperazin-3-ol form.
The reported elimination half-life ranges between 5 to 11 hours.
Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA. In vitro studies have shown that olaparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complex, resulting in disruption of cellular homeostasis and cell death.
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End Use API : Olaparib
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End Use API : Olaparib
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End Use API : Olaparib
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End Use API : Olaparib
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Regulatory Info : Lead Market Dossiers- Under Development
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under Development
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under Development
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under Development
Registration Country : India
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Regulatory Info : Dossier Readiness:Q3 2026
Registration Country : Latvia
Brand Name :
Dosage Form : Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Readiness:Q3 2026
Registration Country : Latvia
Regulatory Info : DISCN
Registration Country : USA
Brand Name : LYNPARZA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 50MG
Packaging :
Approval Date : 2014-12-19
Application Number : 206162
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LYNPARZA
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Packaging :
Approval Date : 2017-08-17
Application Number : 208558
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : LYNPARZA
Dosage Form : TABLET;ORAL
Dosage Strength : 150MG
Packaging :
Approval Date : 2017-08-17
Application Number : 208558
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Lynparza
Dosage Form : Olaparib 50Mg 448 Unita' Oral Use
Dosage Strength : 448 cps 50 mg vial
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Lynparza
Dosage Form : Capsule, hard
Dosage Strength : 50 mg
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : USA
Brand Name : OLAPARIB
Dosage Form : TABLET
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number : 219410
Regulatory Info :
Registration Country : USA
Regulatory Info : Available Dossier- US-EU-RoW
Registration Country : Italy
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Available Dossier- US-EU-RoW
Registration Country : Italy
RLD : Yes
TE Code :
Brand Name : LYNPARZA
Dosage Form : CAPSULE;ORAL
Dosage Strength : 50MG
Approval Date : 2014-12-19
Application Number : 206162
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : LYNPARZA
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG
Approval Date : 2017-08-17
Application Number : 208558
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : LYNPARZA
Dosage Form : TABLET;ORAL
Dosage Strength : 150MG
Approval Date : 2017-08-17
Application Number : 208558
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD :
TE Code :
Brand Name : OLAPARIB
Dosage Form : TABLET
Dosage Strength : 150MG
Approval Date :
Application Number : 219410
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : OLAPARIB
Dosage Form : TABLET
Dosage Strength : 150MG
Approval Date :
Application Number : 217936
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info :
Registration Country : Italy
Brand Name : Lynparza
Dosage Form : Olaparib 50Mg 448 Unita' Oral Use
Dosage Strength : 448 cps 50 mg vial
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Lynparza
Dosage Form : Capsule, hard
Dosage Strength : 50 mg
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Lynparza
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 08/05/2018
Application Number : 20170407000065
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Lynparza
Dosage Form : Film Coated Tablet
Dosage Strength : 150mg
Packaging :
Approval Date : 08/05/2018
Application Number : 20170407000072
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Deregistered
Registration Country : Sweden
Brand Name : Lynparza
Dosage Form : Capsule
Dosage Strength : 50mg
Packaging :
Approval Date : 16/12/2014
Application Number : 20131002000126
Regulatory Info : Deregistered
Registration Country : Sweden
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Lynparza
Dosage Form : Film Coated Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 27/09/2018
Application Number : 66745
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Lynparza
Dosage Form : Film Coated Tablet
Dosage Strength : 150mg
Packaging :
Approval Date : 27/09/2018
Application Number : 66745
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Lynparza
Dosage Form : Film Coated Tablet
Dosage Strength : 150MG
Packaging :
Approval Date : 2018-05-28
Application Number : 114959004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Lynparza
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date : 2018-05-28
Application Number : 114959002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Available Dossier- US-EU-RoW
Registration Country : Italy
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Available Dossier- US-EU-RoW
Registration Country : Italy
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : LYNPARZA
Dosage Form : TABLET
Dosage Strength : 100MG
Packaging : 60/120
Approval Date :
Application Number : 2475200
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : LYNPARZA
Dosage Form : TABLET
Dosage Strength : 150MG
Packaging : 60/120
Approval Date :
Application Number : 2475219
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Australia
Brand Name : Lynparza
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Lynparza
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Lynparza
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Lynparza
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Lynparza
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Lynparza
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Lynparza
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Lynparza
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Lynparza
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Brand Name : Lynparza
Dosage Form :
Dosage Strength :
Packaging : 56
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Under De...
Dosage : Oral Solid Dosage Form
Dosage Strength : 100MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
Brand Name :
Dosage Form : Oral Solid Dosage Form
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Under De...
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Packaging :
Regulatory Info : Lead Market Dossiers- Under De...
Dosage : Oral Solid Dosage Form
Dosage Strength : 150MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Regulatory Info : Dossier Readiness:Q3 2026
Registration Country : Latvia
Brand Name :
Dosage Form : Tablet
Dosage Strength :
Packaging :
Approval Date :
Application Number :
Regulatory Info : Dossier Readiness:Q3 2026
Registration Country : Latvia
Olpha, a JSC AB City subsidiary, is a leading Baltic firm with 50 years of experience in medicines & chemical pharmaceuticals.
Packaging :
Regulatory Info : Dossier Readiness:Q3 2026
Dosage : Tablet
Dosage Strength :
Brand Name :
Approval Date :
Application Number :
Registration Country : Latvia
Regulatory Info :
Registration Country : India
Brand Name : Olaparib
Dosage Form : Tablet
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 100MG
Brand Name : Olaparib
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name : Olaparib
Dosage Form : Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 150MG
Brand Name : Olaparib
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablets
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablets
Dosage Strength : 100mg
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablets
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging :
Regulatory Info :
Dosage : Tablets
Dosage Strength : 150mg
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Related Excipient Companies
Dosage Form : Capsule
Grade : Oral
Brand Name : Sodium Stearyl Fumarate G...
Application : Lubricants & Glidants
Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.
Pharmacopoeia Ref : USP, EP, ICH, Q7GMP
Technical Specs : NA
Ingredient(s) : Sodium Stearyl Fumarate
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Orodispersible Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Dosage Form : Tablet
Grade : Oral
Excipients by Applications
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PharmaCompass offers a list of Olaparib 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 Olaparib manufacturer or Olaparib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Olaparib manufacturer or Olaparib supplier.
PharmaCompass also assists you with knowing the Olaparib API Price utilized in the formulation of products. Olaparib API Price is not always fixed or binding as the Olaparib Price is obtained through a variety of data sources. The Olaparib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one, including repackagers and relabelers. The FDA regulates 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one 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 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one supplier is an individual or a company that provides 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one active pharmaceutical ingredient (API) or 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one finished formulations upon request. The 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one suppliers may include 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one API manufacturers, exporters, distributors and traders.
click here to find a list of 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one DMF (Drug Master File) is a document detailing the whole manufacturing process of 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one active pharmaceutical ingredient (API) in detail. Different forms of 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one DMFs exist exist since differing nations have different regulations, such as 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one DMF submitted to regulatory agencies in the US is known as a USDMF. 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one USDMF includes data on 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Drug Master File in Korea (4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one. The MFDS reviews the 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one KDMF as part of the drug registration process and uses the information provided in the 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one KDMF to evaluate the safety and efficacy of the drug.
After submitting a 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one 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 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one API can apply through the Korea Drug Master File (KDMF).
click here to find a list of 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one suppliers with KDMF on PharmaCompass.
A 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one written confirmation (4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one WC) is an official document issued by a regulatory agency to a 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one manufacturer, verifying that the manufacturing facility of a 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one APIs or 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one finished pharmaceutical products to another nation, regulatory agencies frequently require a 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one WC (written confirmation) as part of the regulatory process.
click here to find a list of 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one suppliers with NDC on PharmaCompass.
4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one 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 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one 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 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one GMP manufacturer or 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one GMP API supplier for your needs.
A 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one CoA (Certificate of Analysis) is a formal document that attests to 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one's compliance with 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one specifications and serves as a tool for batch-level quality control.
4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one CoA mostly includes findings from lab analyses of a specific batch. For each 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one 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.
4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one may be tested according to a variety of international standards, such as European Pharmacopoeia (4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one EP), 4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one JP (Japanese Pharmacopeia) and the US Pharmacopoeia (4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one USP).