Synopsis
Synopsis
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CEP/COS
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DRUG PRODUCT COMPOSITIONS
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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.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-19
Pay. Date : 2022-03-31
DMF Number : 35742
Submission : 2021-03-30
Status : Active
Type : II
NDC Package Code : 71796-034
Start Marketing Date : 2021-11-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40467
Submission : 2024-09-28
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Jinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.
Tofigh Daru develops & synthesizes a diverse range of APIs in Anticancer, Narcotics, Cardiovascular to Immunomodulatory Segments.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38957
Submission : 2023-09-28
Status : Active
Type : II
API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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Details:
RP-3467 is a Polθ ATPase inhibitor, small molecule drug candidate, which is being evaluated in combination with olaparib for the treatment of advanced solid tumors.
Lead Product(s): RP-3467,Olaparib
Therapeutic Area: Oncology Brand Name: RP-3467
Study Phase: Phase IProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2024
Repare Doses First Patient in Phase 1 RP-3467 Trial Targeting Polθ in Cancer
Details : RP-3467 is a Polθ ATPase inhibitor, small molecule drug candidate, which is being evaluated in combination with olaparib for the treatment of advanced solid tumors.
Brand Name : RP-3467
Molecule Type : Small molecule
Upfront Cash : Not Applicable
October 14, 2024
Details:
EIS-12656 targets ALC1 through allosteric mechanisms, suppressing the cancer-relevant genome reorganization induced by DNA damage. This leads to ALC1 chromatin trapping and cancer cell killing.
Lead Product(s): EIS-12656,Olaparib
Therapeutic Area: Oncology Brand Name: EIS-12656
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 16, 2024
Lead Product(s) : EIS-12656,Olaparib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Eisbach Doses First Patient in Phase 1/2 Trial for EIS-12656 in Refractory Solid Tumors
Details : EIS-12656 targets ALC1 through allosteric mechanisms, suppressing the cancer-relevant genome reorganization induced by DNA damage. This leads to ALC1 chromatin trapping and cancer cell killing.
Brand Name : EIS-12656
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 16, 2024
Details:
Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone indicated for the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer.
Lead Product(s): Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Brand Name: Lynparza
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Foundation Medicine
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2024
Lead Product(s) : Olaparib,Abiraterone Acetate,Prednisone
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Foundation Medicine
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves FoundationOne®CDx As Companion Diagnostic for Prostate Cancer
Details : Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone indicated for the treatment of adult patients with BRCA-mutated metastatic castration-resistant prostate cancer.
Brand Name : Lynparza
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 03, 2024
Details:
Imfinzi (durvalumab) a PD-L1 inhibitor which is approved in combination with Lynparza (olaparib) for the treatment of advanced or recurrent endometrial cancer.
Lead Product(s): Durvalumab,Olaparib,Carboplatin
Therapeutic Area: Oncology Brand Name: Imfinzi
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 17, 2024
Lead Product(s) : Durvalumab,Olaparib,Carboplatin
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Imfinzi approved in the US for endometrial cancer
Details : Imfinzi (durvalumab) a PD-L1 inhibitor which is approved in combination with Lynparza (olaparib) for the treatment of advanced or recurrent endometrial cancer.
Brand Name : Imfinzi
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 17, 2024
Details:
Olaparib Tablets (100mg/150mg) has obtained drug registration approval granted by the National Medical Products Administration of the People’s Republic of China.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Brand Name: Olaparib-Generic
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2024
Olaparib Tablets Obtains Drug Registration Approval
Details : Olaparib Tablets (100mg/150mg) has obtained drug registration approval granted by the National Medical Products Administration of the People’s Republic of China.
Brand Name : Olaparib-Generic
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 03, 2024
Details:
TNG348 is a novel selective inhibitor of USP1 which is in phase 1/2 clinical trials as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant cancers.
Lead Product(s): TNG348,Olaparib
Therapeutic Area: Oncology Brand Name: TNG348
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2024
Lead Product(s) : TNG348,Olaparib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Medivir´s licensee, Tango Therapeutics, has Discontinued Development of its TNG348 Program
Details : TNG348 is a novel selective inhibitor of USP1 which is in phase 1/2 clinical trials as a single agent and in combination with olaparib, a PARP inhibitor, in patients with BRCA1/2-mutant cancers.
Brand Name : TNG348
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 23, 2024
Details:
Keytruda (pembrolizumab) is being evaluated with Lynparza (olaparib), a PARP inhibitor, for metastatic nonsquamous non-small cell lung cancer.
Lead Product(s): Pembrolizumab,Olaparib,Pemetrexed
Therapeutic Area: Oncology Brand Name: Keytruda
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 21, 2024
Lead Product(s) : Pembrolizumab,Olaparib,Pemetrexed
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Merck Updates On Phase 3 KEYLYNK-006 Trial with KEYTRUDA® Plus LYNPARZA®
Details : Keytruda (pembrolizumab) is being evaluated with Lynparza (olaparib), a PARP inhibitor, for metastatic nonsquamous non-small cell lung cancer.
Brand Name : Keytruda
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 21, 2024
Details:
Imfinzi (durvalumab) with platinum-based chemotherapy followed by Lynparza (olaparib), demonstrated improved outcomes in patients with mismatch repair proficient advanced endometrial cancer.
Lead Product(s): Durvalumab,Olaparib
Therapeutic Area: Oncology Brand Name: Imfinzi
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 18, 2024
Lead Product(s) : Durvalumab,Olaparib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lynparza and Imfinzi Demonstrated Strong Benefit Doubling Median Duration Of Response
Details : Imfinzi (durvalumab) with platinum-based chemotherapy followed by Lynparza (olaparib), demonstrated improved outcomes in patients with mismatch repair proficient advanced endometrial cancer.
Brand Name : Imfinzi
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 18, 2024
Details:
Ibyra (olaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor, which is approved in India for the treatment of HRD-positive and BRACA-positive cancer patients.
Lead Product(s): Olaparib
Therapeutic Area: Oncology Brand Name: Ibyra
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 13, 2024
Zydus Launches Anti-Cancer Generic Drug Olaparib in India
Details : Ibyra (olaparib) is a poly (ADP-ribose) polymerase (PARP) inhibitor, which is approved in India for the treatment of HRD-positive and BRACA-positive cancer patients.
Brand Name : Ibyra
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 13, 2024
Details:
TNG348 is a selective USP1 inhibitor in phase 1/2 trials, tested as a single agent and with olaparib for treating BRCA1/2-mutant or other HRD+ cancers.
Lead Product(s): TNG348,Olaparib
Therapeutic Area: Oncology Brand Name: TNG348
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2024
Lead Product(s) : TNG348,Olaparib
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Tango Doses First Patient in Phase 1/2 Trial Of TNG348 for Cancers
Details : TNG348 is a selective USP1 inhibitor in phase 1/2 trials, tested as a single agent and with olaparib for treating BRCA1/2-mutant or other HRD+ cancers.
Brand Name : TNG348
Molecule Type : Small molecule
Upfront Cash : Not Applicable
January 03, 2024
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 : 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 : 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 : 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 : Originator
Registration Country : South Africa
Brand Name : Lynparza 100
Dosage Form : TAB
Dosage Strength : 100mg
Packaging : 56X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
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
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 :
Regulatory Info :
Registration Country : Sweden
Brand Name : Lynparza
Dosage Form : HARD CAPSULES
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
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 : Switzerland
Brand Name : Lynparza
Dosage Form : Filmtabl
Dosage Strength : 100mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Brand Name : Lynparza
Dosage Form : Filmtabl
Dosage Strength : 150mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
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 :
Registration Country : Italy
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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 :
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
Regulatory Info :
Registration Country : Argentina
Brand Name :
Dosage Form : Liquid-filled capsules
Dosage Strength : 150MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Argentina
Packaging :
Regulatory Info :
Dosage : Liquid-filled capsules
Dosage Strength : 150MG
Brand Name :
Approval Date :
Application Number :
Registration Country : Argentina
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