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ACTIVE PHARMA INGREDIENTS

31 API Suppliers, 13 USDMF, 3 EU WC, 4 KDMF, 11 NDC API, 21 Listed Suppliers, $ API Reference Price

31 API Suppliers
13 USDMF
3 EU WC
4 KDMF
11 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

73 Drugs in Development

73 Drugs in Development

INTERMEDIATES

30 Intermediates Suppliers

30 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

40 FDF Dossiers, 3 FDA Orange Book, 7 Europe, 2 Canada, 20 Australia, 2 South Africa, 6 Listed Dossiers

40 FDF Dossiers
3 FDA Orange Book
7 Europe
2 Canada
20 Australia
2 South Africa
6 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Minakem, 1 Rochem International Inc, 13 SPI Pharma, 4 DKSH, 1 Faran Shimi Pharmaceutical, 2 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 2 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 2 Alcedo Pharmachem, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 4 BASF, 1 Clariant, 10 Corel Pharma Chem, 1 Finar, 6 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 4 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 14 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 4 Microlex e.U, 1 NEWEDGE Overseas, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 1 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 5 Roquette, 7 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 2 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem

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DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 3 STOCK RECAP #PipelineProspector, 273 NEWS #PharmaBuzz

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5 DATA COMPILATION #PharmaFlow
3 STOCK RECAP #PipelineProspector
273 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 4 Finished Drug Prices, 15 Annual Reports

globalSalesInformation
1 US Medicaid Prescriptions
4 Finished Drug Prices
15 Annual Reports

MARKET PLACE

9 APIs, 5 FDF Dossiers

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9 APIs
5 FDF Dossiers

PATENTS & EXCLUSIVITIES

150 US Patents, 14 US Exclusivities, 4 Health Canada Patents

patents
150 US Patents
14 US Exclusivities
4 Health Canada Patents

REF. STANDARDS & IMPURITIES

13 Others

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13 Others

Axplora Olaparib

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 7,565

MARKET PLACE

API

FDF

30INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

73DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

150

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

273

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

460,720,287

Annual Reports (USD Million)

16,593

Finished Drug Prices

117 RELATED EXCIPIENT COMPANIES

224EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 763113-22-0, Lynparza, Azd2281, Azd-2281, Ku-0059436, Azd 2281

Molecular Formula

C₂₄H₂₃FN₄O₃

Molecular Weight

434.5 g/mol

InChI Key

FDLYAMZZIXQODN-UHFFFAOYSA-N

FDA UNII

WOH1JD9AR8

Olaparib is a small molecule inhibitor of the nuclear enzyme poly(ADP-ribose) polymerase (PARP) with potential chemosensitizing, radiosensitizing, and antineoplastic activities. Olaparib selectively binds to and inhibits PARP, inhibiting PARP-mediated repair of single strand DNA breaks; PARP inhibition may enhance the cytotoxicity of DNA-damaging agents and may reverse tumor cell chemoresistance and radioresistance. PARP catalyzes post-translational ADP-ribosylation of nuclear proteins and can be activated by single-stranded DNA breaks.

Olaparib is a Poly(ADP-Ribose) Polymerase Inhibitor. The mechanism of action of olaparib is as a Poly(ADP-Ribose) Polymerase Inhibitor.

1 2D Structure

Olaparib

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-[[3-[4-(cyclopropanecarbonyl)piperazine-1-carbonyl]-4-fluorophenyl]methyl]-2H-phthalazin-1-one

2.1.2 InChI

InChI=1S/C24H23FN4O3/c25-20-8-5-15(14-21-17-3-1-2-4-18(17)22(30)27-26-21)13-19(20)24(32)29-11-9-28(10-12-29)23(31)16-6-7-16/h1-5,8,13,16H,6-7,9-12,14H2,(H,27,30)

2.1.3 InChI Key

FDLYAMZZIXQODN-UHFFFAOYSA-N

2.1.4 Canonical SMILES

C1CC1C(=O)N2CCN(CC2)C(=O)C3=C(C=CC(=C3)CC4=NNC(=O)C5=CC=CC=C54)F

2.2 Other Identifiers

2.2.1 UNII

WOH1JD9AR8

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Azd 2281

2. Azd-2281

3. Azd221

4. Azd2281

5. Lynparza

2.3.2 Depositor-Supplied Synonyms

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)-

2.4 Create Date

2008-02-11

3 Chemical and Physical Properties

Molecular Formula	C₂₄H₂₃FN₄O₃
Molecular Weight	434.5 g/mol
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 Å²
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

4 Drug and Medication Information

4.1 Drug Indication

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.

5 Pharmacology and Biochemistry

5.1 Pharmacology

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.

5.2 MeSH Pharmacological Classification

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.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

OLAPARIB

5.3.2 FDA UNII

WOH1JD9AR8

5.3.3 Pharmacological Classes

Poly(ADP-Ribose) Polymerase Inhibitors [MoA]; Poly(ADP-Ribose) Polymerase Inhibitor [EPC]

5.4 ATC Code

L01XK01

L - Antineoplastic and immunomodulating agents

L01 - Antineoplastic agents

L01X - Other antineoplastic agents

L01XK - Poly (adp-ribose) polymerase (parp) inhibitors

L01XK01 - Olaparib

5.5 Absorption, Distribution and Excretion

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.

5.6 Metabolism/Metabolites

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.

5.7 Biological Half-Life

The reported elimination half-life ranges between 5 to 11 hours.

5.8 Mechanism of Action

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.

API SUPPLIERS

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Axplora

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API Reference Price

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MCN NO. 5000947","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR","city":"AHMEDABAD\/GUJRAT","supplier":"XXODUXX LLXX","supplierCountry":"UNITED STATES","foreign_port":"LOS ANGELES","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"31.00","actualQuantity":"31","unit":"KGS","unitRateFc":"2059.9","totalValueFC":"64581.8","currency":"USD","unitRateINR":"172929.6","date":"07-Sep-2023","totalValueINR":"5360818","totalValueInUsd":"64581.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29339990","bill_no":"1003720","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"LOS ANGELES","supplierAddress":"N\/A","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705948200,"product":"LUT-65 OLAPARIB FORMA A (CAS763113-22-0 IUPAC4-(3-(4-(CYCLOPROPANECARBONYL)PIPERAZINE-1-CARBONYL)-4-FLOROPHENYL)METHY","address":"SANDOZ HOUSE","city":"MUMBAI ,MAHARASHTRA","supplier":"OLON S.P.A","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"SANDOZ B2B","customerCountry":"INDIA","quantity":"23.73","actualQuantity":"23.73","unit":"KGS","unitRateFc":"6600","totalValueFC":"158480.4","currency":"USD","unitRateINR":"555060","date":"23-Jan-2024","totalValueINR":"13171573.8","totalValueInUsd":"158480.4","indian_port":"Bombay Air","hs_no":"29335990","bill_no":"9785375","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"STR. RIVOLTANA KM 6\/720053 RODANO MI ITSDNF ITALY","customerAddress":"SANDOZ HOUSE"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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Drugs in Development

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INTERMEDIATES SUPPLIERS

01

Beijing Mesochem Technology

China

BIO Partnering at JPM

Not Confirmed

Mesochem is focused on incessant innovation along with the R&D of new APIs.

1-(Cyclopropylcarbonyl)piperazine

CAS Number : CAS-59878-57-8

End Use API : Olaparib

Product Web Link

Corporate PDF

02

Beijing Mesochem Technology

China

BIO Partnering at JPM

Not Confirmed

Mesochem is focused on incessant innovation along with the R&D of new APIs.

2-Fluoro-5-(4-oxo-3,4-dihydrophthalazin-1-ylmethyl...

CAS Number : CAS-763114-26-7

End Use API : Olaparib

Portfolio PDF

Product Web Link

Virtual Booth

China

BIO Partnering at JPM

Not Confirmed

Only 10 entries up to this point, click to access all

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FDF Dossiers

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FDA Orange Book

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Europe

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Canada

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Australia

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South Africa

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Listed Dossiers

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Excipients by Applications

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Coating Systems & Additives

Fillers, Diluents & Binders

Controlled & Modified Release

Direct Compression

Film Formers & Plasticizers

Chewable & Orodispersible Aids

Taste Masking

Lubricants & Glidants

Granulation

Disintegrants & Superdisintegrants

Thickeners and Stabilizers

Parenteral

API Stability Enhancers

Coloring Agents

Solubilizers

Topical

Co-Processed Excipients

Empty Capsules

Vegetarian Capsules

Emulsifying Agents

Rheology Modifiers

Surfactant & Foaming Agents

Digital Content

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DATA COMPILATION #PharmaFlow

STOCK RECAP #PipelineProspector

NEWS #PharmaBuzz

Global Sales Information

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US Medicaid Prescriptions

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Finished Drug Prices

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Annual Reports

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Market Place

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APIs

Olaparib API needed in Brazil [ENA21069]

An independent consultant based in Brazil having 30+ years of experience in the area of sourcing and foreign trade is looking for suppliers of Olaparib API for commercial purposes. The suppliers must support this enquiry with CoA.

08 Nov 2024

Various APIs needed in Georgia [ENA14586]

A company that deals in various pharmaceutical products is looking for suppliers of Various APIs for commercial purpose. The suppliers must support this enquiry with CoA. 1. Piperacillin + Tasobactam API 2. Imipenem + Cilastatin API 3. Sodium Bicarbonate API 4. Pantoprazole API 5. Pembrolizumab API 6. Olaparib API 7. Vandetanib API 8. Imatinib API 9. Bevacizumab API 10. Trastuzumab API

05 Aug 2022

Olaparib API needed in Brazil [ENA13652]

A large pharmaceutical manufacturing company that deals in portfolios like dermatological, cardiological, gynaecological, gastric, oncology, respiratory & CNS is looking for suppliers of Olaparib API for development purpose. The suppliers must support this enquiry with DMF, GMP & CoA.

17 May 2022

Olaparib (1 kg) API needed in Bangladesh [ENA12353]

A company based in India that deals in the research, development, manufacturing & marketing of various pharmaceutical products for human & veterinary use is looking for suppliers of Olaparib (1 kg) API for commercial purpose. The suppliers must support this enquiry with USDMF & CoA.

08 Jan 2022

Various APIs needed in Japan [ENA11329]

A company that deals in the export of chemicals & pharmaceutical products is looking for suppliers of Various APIs for development purposes. The required quantity is 500 g & 1 kg for each. The suppliers must support this enquiry with CoA. 1. Olaparib API 2. Ipragliflozin L-proline API 3. Apixaban API

07 Sep 2021

Olaparib (5 kg) API needed in India [ENA10786]

A specialty pharmaceutical organization, which deals in formulation & analytical development of oral dosage forms & injectables is looking for suppliers of Olaparib (5 kg) API for development purpose.

03 Jul 2021

Olaparib (25 kg & 90 kg) API needed in China [ENA09421]

Conier Chem & Pharma, a company that aims to develop and market innovative products is looking for suppliers of Olaparib (25 kg & 90 kg) API. Interested suppliers can contact them via their email: sales03@conier.com.

06 Jan 2021

Olaparib API (MOQ) needed in Bangladesh [ENA03782]

The world-class healthcare solution provider which is engaged in the manufacture and marketing of a wide range of therapeutic drugs, bulk pellets and animal health and nutrition products is looking for suppliers of Olaparib API (MOQ) for domestic consumption.

28 Mar 2019

Enquiry// Various Active Pharmaceutical Ingredients needed in Bangladesh [ENA01104]

Rainbow Pacific Ltd, a distribution company in Bangladesh is looking for suppliers of following APIs for their client: 1. Alectinib HCl INN (Micronized) 50 kg 2. Olaparib 14.5 kg 3. Apixaban 500 g 4. Cabozantinib Malate 4 kg 5. Neratinib Maleate 5 kg 6. Brigatinib 4.5 kg 7. Ponatinib HCl 2.5 kg Interested suppliers should contact Ms Mallika via Email: rainpac1@gmail.com or Tel: 88028033857.

17 Jul 2018

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FDF DOSSIERS

Tender// Various Finished Dosage Formulations needed in Czech Republic [ENA18409]

Masaryk Institute of Oncology is looking for supplies of Various Finished Dosage Formulations for commercial purposes. The deadline is 21-Nov-2023. 1. Filgrastim (48 MU) Solution for Injections. The required quantity is 3,200 units. 2. Olaparib (150 mg) Tablets. The required quantity is 1,500 units.

20 Oct 2023

Tender// Various Finished Dosage Formulations needed in Bulgaria [ENA16249]

Complex Oncology Center-Veliko Tarnovo Ltd is looking for supplies of Various Finished Dosage Formulations for commercial purposes. The deadline is 24-Feb-2023. 1. Apalutamide (60 mg) Tablets. The required quantity is 864,000 units. 2. Fentanyl (133 mcg) Sublingual Tablets. The required quantity is 638,400 units. 3. Olaparib (150 mg) Tablets. The required quantity is 604,800 units.

31 Jan 2023

Tender// Various Finished Dosage Formulations needed in Bulgaria [ENA13830]

Complex Oncological Center - Plovdiv Eood is looking for supplies of Various Finished Dosage Formulations for commercial purpose. The deadline is 27-Jun-2022. 1. Olaparib (150 mg) Tablets. The required quantity is 7 million units. 2. Fluorouracil (1000 mg) Injections. The required quantity is 6 million units.

01 Jun 2022

Tender// Various Finished Dosage Formulations needed in Poland [ENA11713]

Provincial Zespol Szpital im. dr. Roman Ostrzycki in Konin is looking for supplies of Various Finished Dosage Formulations for commercial purpose. The deadline is 22-Nov-2021. 1. Olaparib (100 mg & 150 mg) Capsules. The required quantity is 1,680 units & 5,840 units respectively. 2. Capecitabine (150 mg & 500 mg) Tablets. The required quantity is 4,320 units & 10,320 units respectively. 3. Thalidomide (100 mg) Capsules. The required quantity is 7,710 units. 4. Paclitaxel (300 mg & 100 mg) Infusions. The required quantity is 81,000 units & 27,000 units respectively.

22 Oct 2021

Various Finished Dosage Formulations needed in Bahrain [ENA10581]

05 Jun 2021

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Patents & EXCLUSIVITIES

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US Patents

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US Exclusivities

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Health Canada Patents

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REF. STANDARDS & IMPURITIES

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Others

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ABOUT THIS PAGE

Olaparib Manufacturers

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

Olaparib Suppliers

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

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

Olaparib USDMF

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

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

click here to find a list of Olaparib suppliers with USDMF on PharmaCompass.

Olaparib KDMF

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

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

After submitting a Olaparib 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 Olaparib API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Olaparib suppliers with KDMF on PharmaCompass.

Olaparib WC

A Olaparib written confirmation (Olaparib WC) is an official document issued by a regulatory agency to a Olaparib manufacturer, verifying that the manufacturing facility of a Olaparib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Olaparib APIs or Olaparib finished pharmaceutical products to another nation, regulatory agencies frequently require a Olaparib WC (written confirmation) as part of the regulatory process.

click here to find a list of Olaparib suppliers with Written Confirmation (WC) on PharmaCompass.

Olaparib 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 Olaparib as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Olaparib suppliers with NDC on PharmaCompass.

Olaparib GMP

Olaparib 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 Olaparib 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 Olaparib GMP manufacturer or Olaparib GMP API supplier for your needs.

Olaparib CoA

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

Olaparib CoA mostly includes findings from lab analyses of a specific batch. For each Olaparib 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.

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

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ACTIVE PHARMA INGREDIENTS

31 API Suppliers

13 USDMF

3 EU WC

4 KDMF

11 NDC API

21 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

73 Drugs in Development

INTERMEDIATES

30 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

40 FDF Dossiers

3 FDA Orange Book

7 Europe

2 Canada

20 Australia

2 South Africa

6 Listed Dossiers

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EXCIPIENTS BY APPLICATIONS

46 Coating Systems & Additives

29 Fillers, Diluents & Binders

18 Controlled & Modified Release

17 Direct Compression

14 Film Formers & Plasticizers

13 Chewable & Orodispersible Aids

12 Taste Masking

8 Lubricants & Glidants

7 Granulation

7 Disintegrants & Superdisintegrants

6 Thickeners and Stabilizers

6 Parenteral

5 API Stability Enhancers

5 Coloring Agents