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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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24 API Suppliers, 10 USDMF, 4 EU WC, 1 KDMF, 8 NDC API, 15 Listed Suppliers, $ API Reference Price

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10 USDMF
4 EU WC
1 KDMF
8 NDC API
15 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

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4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

93 FDF Dossiers, 39 FDA Orange Book, 18 Europe, 8 Canada, 20 Australia, 8 Listed Dossiers

93 FDF Dossiers
39 FDA Orange Book
18 Europe
8 Canada
20 Australia
8 Listed Dossiers

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 15 SPI Pharma, 3 DKSH, 3 Faran Shimi Pharmaceutical, 6 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 10 Corel Pharma Chem, 1 Finar, 5 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 14 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Novo Excipients, 3 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 10 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 1 Vasa Pharmachem

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DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 24 NEWS #PharmaBuzz

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1 DATA COMPILATION #PharmaFlow
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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 18 Finished Drug Prices, 8 Annual Reports

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1 US Medicaid Prescriptions
18 Finished Drug Prices
8 Annual Reports

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3 APIs, 2 FDF Dossiers

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3 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

52 US Patents, 8 Health Canada Patents

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52 US Patents
8 Health Canada Patents

Synopsis

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US Patents

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Health Canada Patents

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News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

582,841,269

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7,222

Finished Drug Prices

125 RELATED EXCIPIENT COMPANIES

227EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 475086-01-2, Ns-304, Uptravi, Act-293987, Ns 304, Act 293987

Molecular Formula

C₂₆H₃₂N₄O₄S

Molecular Weight

496.6 g/mol

InChI Key

QXWZQTURMXZVHJ-UHFFFAOYSA-N

FDA UNII

5EXC0E384L

Selexipag was approved by the United States FDA on December 22, 2015 for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce risk of hospitalization. PAH is a relatively rare disease with usually a poor prognosis requiring more treatment options to prolong long-term outcomes. Marketed by Actelion Pharmaceuticals under brand name Uptravi, selexipag and its active metabolite, ACT-333679 (MRE-269), act as agonists of the prostacyclin receptor to increase vasodilation in the pulmonary circulation and decrease elevated pressure in the blood vessels supplying blood to the lungs.

Selexipag is a Prostacyclin Receptor Agonist. The mechanism of action of selexipag is as a Prostacyclin Receptor Agonist.

1 2D Structure

Selexipag

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

2-[4-[(5,6-diphenylpyrazin-2-yl)-propan-2-ylamino]butoxy]-N-methylsulfonylacetamide

2.1.2 InChI

InChI=1S/C26H32N4O4S/c1-20(2)30(16-10-11-17-34-19-24(31)29-35(3,32)33)23-18-27-25(21-12-6-4-7-13-21)26(28-23)22-14-8-5-9-15-22/h4-9,12-15,18,20H,10-11,16-17,19H2,1-3H3,(H,29,31)

2.1.3 InChI Key

QXWZQTURMXZVHJ-UHFFFAOYSA-N

2.1.4 Canonical SMILES

CC(C)N(CCCCOCC(=O)NS(=O)(=O)C)C1=CN=C(C(=N1)C2=CC=CC=C2)C3=CC=CC=C3

2.2 Other Identifiers

2.2.1 UNII

5EXC0E384L

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 2-(4-((5,6-diphenylpyrazin-2-yl)(isopropyl)amino)butoxy)-n-(methylsulfonyl)acetamide

2. Act 293987

3. Act-293987

4. Act293987

5. Ns-304

6. Uptravi

2.3.2 Depositor-Supplied Synonyms

1. 475086-01-2

2. Ns-304

3. Uptravi

4. Act-293987

5. Ns 304

6. Act 293987

7. 2-(4-((5,6-diphenylpyrazin-2-yl)(isopropyl)amino)butoxy)-n-(methylsulfonyl)acetamide

8. 5exc0e384l

9. 2-[4-[(5,6-diphenylpyrazin-2-yl)-propan-2-ylamino]butoxy]-n-methylsulfonylacetamide

10. Ns-304;act-293987

11. 2-{4-[(5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}-n-(methanesulfonyl)acetamide

12. 2-(4-((5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino)butoxy}-n-(methanesulfonyl)acetamide

13. 2-[4-[(5,6-diphenyl-2-pyrazinyl)(1-methylethyl)amino]butoxy]-n-(methylsulfonyl)acetamide

14. Unii-5exc0e384l

15. Selexipag [usan:inn]

16. 2-(4-((5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino)butoxy)-n-(methanesulfonyl)acetamide

17. Uptravi (tn)

18. Act293987

19. Ns-304(selexipag)

20. Selexipag(ns-304)

21. Selexipag [inn]

22. Selexipag [jan]

23. Selexipag [mi]

24. Selexipag [usan]

25. Selexipag [who-dd]

26. Selexipag (jan/usan/inn)

27. Schembl674122

28. Chembl238804

29. Gtpl7552

30. Selexipag [orange Book]

31. Chebi:90844

32. Dtxsid301027959

33. Amy10851

34. Bcp09146

35. Zinc3990451

36. Bdbm50235383

37. Mfcd10567093

38. S3726

39. Akos024457572

40. Ccg-269668

41. Cs-3774

42. Db11362

43. Sb17055

44. 2-{4-[n-(5,6-diphenylpyrazin-2-yl)-n-isopropylamino]butyloxy}-n-(methylsulfonyl)acetamide

45. Ncgc00370833-01

46. Ncgc00370833-02

47. Ac-30209

48. Bs-16872

49. Hy-14870

50. Db-119997

51. B7378

52. Ft-0776043

53. D09994

54. A857156

55. Q15424759

56. 2-(4-((5,6-diphenyl-2-pyrazinyl)(isopropyl)amino)butoxy)-n-(methylsulfonyl)acetamide

57. 2-[4-[[5,6-di(phenyl)pyrazin-2-yl]-propan-2-ylamino]butoxy]-n-methylsulfonylacetamide

58. 2-{4-[(5,6-diphenylpyrazin-2-yl)(propan-2-yl)amino]butoxy}-n-methanesulfonylacetamide

2.4 Create Date

2006-10-25

3 Chemical and Physical Properties

Molecular Formula	C₂₆H₃₂N₄O₄S
Molecular Weight	496.6 g/mol
XLogP3	3.8
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	7
Rotatable Bond Count	12
Exact Mass	496.21442669 g/mol
Monoisotopic Mass	496.21442669 g/mol
Topological Polar Surface Area	110 Å²
Heavy Atom Count	35
Formal Charge	0
Complexity	730
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

Selexipag is indicated for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce risk of hospitalization.

FDA Label

Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) IIIII, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies.

Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.

5 Pharmacology and Biochemistry

5.1 Pharmacology

At the maximum tolerated dose of 1600 mcg twice per day, selexipag was not found to prolong the QT interval to a clinically relevant extent. Both selexipag and its metabolite caused concentration-dependent inhibition of platelet aggregation in vitro with IC50 of 5.5 M and 0.21 M, respectively. However, at clinically relevant concentrations, there was no effect on platelet aggregation test parameters following multiple dose administration of selexipag in healthy patients.

5.2 MeSH Pharmacological Classification

Antihypertensive Agents

Drugs used in the treatment of acute or chronic vascular HYPERTENSION regardless of pharmacological mechanism. Among the antihypertensive agents are DIURETICS; (especially DIURETICS, THIAZIDE); ADRENERGIC BETA-ANTAGONISTS; ADRENERGIC ALPHA-ANTAGONISTS; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; CALCIUM CHANNEL BLOCKERS; GANGLIONIC BLOCKERS; and VASODILATOR AGENTS. (See all compounds classified as Antihypertensive Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

SELEXIPAG

5.3.2 FDA UNII

5EXC0E384L

5.3.3 Pharmacological Classes

Prostacyclin Receptor Agonists [MoA]; Prostacyclin Receptor Agonist [EPC]

5.4 ATC Code

B01AC27

B - Blood and blood forming organs

B01 - Antithrombotic agents

B01A - Antithrombotic agents

B01AC - Platelet aggregation inhibitors excl. heparin

B01AC27 - Selexipag

5.5 Absorption, Distribution and Excretion

Absorption

After oral administration, maximum concentrations of selexipag and its metabolite were observed to be reached at 1-3 and 3-4 hours, respectively. Absorption was impaired in the presence of food, resulting in delayed time to maximum concentration as well as ~30% lower peak plasma concentration. However, exposure was not found to be significantly affected by food.

Route of Elimination

93% in feces, 12% in urine.

Clearance

On average, 35 L/hour.

5.6 Metabolism/Metabolites

Selexipag yields its active metabolite by hydrolysis of the acylsulfonamide by the enzyme hepatic carboxylesterase 1. Oxidative metabolism catalyzed by CYP3A4 and CYP2C8 results in hydroxylated and dealkylated products. UGT1A3 and UGT2B7 are involved in the glucuronidation of the active metabolite. Other than active metabolite, other metabolites in circulation do not exceed 3% of the total drug-related material.

5.7 Biological Half-Life

Selexipag's terminal half life is 0.8-2.5 hours. The active metabolite's terminal half life is 6.2-13.5 hours.

5.8 Mechanism of Action

Selexipag is a selective prostacyclin (IP, also called PGI2) receptor agonist. The key features of pulmonary arterial hypertension include a decrease in prostacyclin and prostacyclin synthase (enzyme that helps produce prostacyclin) in the lung. Prostacyclin is a potent vasodilator with anti-proliferative, anti-inflammatory, and anti-thrombotic effects; therefore, there is strong rationale for treatment with IP receptor agonists. Selexipag is chemically distinct as it is not PGI2 or a PGI2 analogue and has high selectivity for the IP receptor. It is metabolized by carboxylesterase 1 to yield an active metabolite (ACT-333679) that is approximately 37 times more potent than selexipag. Both selexipag and its metabolite are selective for the IP receptor over other prostanoid receptors.

API SUPPLIERS

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USDMF

01

Biophore India Pharmaceuticals Pvt L...

India

DCAT Week

Attending

Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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India

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Digital Content

SELEXIPAG

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 33947

Submission : 2019-06-18

Status : Active

Type : II

02

Alembic Pharmaceuticals Ltd

India

BIO Partnering at JPM

Not Confirmed

03

Apicore Llc

India

India

BIO Partnering at JPM

Not Confirmed

Not Confirmed

10

Zhejiang Huayi Pharmaceutical Co Ltd

China

BIO Partnering at JPM

Not Confirmed

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EU WC

01

Alembic Pharmaceuticals Limited

India

India

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Not Confirmed

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API Reference Price

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BEOGRAD","customer":"HEMOFARM A.D.","customerCountry":"SERBIA","quantity":"0.14","actualQuantity":"0.14","unit":"KGS","unitRateFc":"150000","totalValueFC":"20793.8","currency":"USD","unitRateINR":12221428.571428571,"date":"22-May-2023","totalValueINR":"1711000","totalValueInUsd":"20793.8","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"0","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"SERBIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BOMBAY AIR","supplierAddress":"PLOT NO 34 SY NO 30\/P 38\/P 39\/P,GA CHIBOWLI KONDAPUR, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1692815400,"product":"SELEXIPAG","address":"ALEMBIC ROAD","city":"VADODARA","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"Z TO ORDER AND NA","customerCountry":"GREECE","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"250000","totalValueFC":"24722.2","currency":"USD","unitRateINR":20478954.539999999,"date":"24-Aug-2023","totalValueINR":"2047895.454","totalValueInUsd":"24722.2","indian_port":"AHMEDABAD AIR","hs_no":"29181990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"AHMEDABAD AIR","supplierAddress":"ALEMBIC ROAD, VADODARA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698863400,"product":"SELEXIPAG(FORM-P)(NET QTY: 5 GMS)","address":"PLOT NO.C-24, MNS HOUSE,","city":"HYDERABAD, AP.","supplier":"MAITHRI DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"AUCKLAND","customer":"TO","customerCountry":"NEW ZEALAND","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"2500","totalValueFC":"12321.2","currency":"USD","unitRateINR":205200,"date":"02-Nov-2023","totalValueINR":"1026000","totalValueInUsd":"12321.2","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"5072539","productDescription":"API","marketType":"REGULATED MARKET","country":"NEW ZEALAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.C-24, MNS HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1702578600,"product":"SELEXIPAG","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"DR. MICKAEL MORIN\/DR. MATHILDE","customerCountry":"SWITZERLAND","quantity":"0.00","actualQuantity":"2","unit":"GMS","unitRateFc":"38000","totalValueFC":"816.9","currency":"INR","unitRateINR":34000,"date":"15-Dec-2023","totalValueINR":"68000","totalValueInUsd":"816.9","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"6066968","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1704306600,"product":"SELEXIPAG","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CIPLA","supplierCountry":"INDIA","foreign_port":"BASLE","customer":"DR. MICKAEL MORIN\/DR. MATHILDE","customerCountry":"SWITZERLAND","quantity":"0.00","actualQuantity":"2","unit":"GMS","unitRateFc":"38000","totalValueFC":"820","currency":"INR","unitRateINR":34074.599999999999,"date":"04-Jan-2024","totalValueINR":"68149.2","totalValueInUsd":"820","indian_port":"Bombay Air","hs_no":"29359090","bill_no":"6514354","productDescription":"API","marketType":"REGULATED MARKET","country":"SWITZERLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"MUMBAI CENTRAL,, MUMBAI, MAHARASHTRA.","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1708108200,"product":"SELEXIPAG","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA","supplierCountry":"INDIA","foreign_port":"MOSCOW DOMODEDOVO","customer":"PSK PHARMA LTD.","customerCountry":"RUSSIA","quantity":"0.02","actualQuantity":"24","unit":"GMS","unitRateFc":"5210","totalValueFC":"1507","currency":"INR","unitRateINR":5210,"date":"17-Feb-2024","totalValueINR":"125040","totalValueInUsd":"1507","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"7617251","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SYNO.257 258\/1, DNO.11-6\/56,, VILLAGE BALANGAR POST HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713897000,"product":"ACTIVE PHARMACEUTICALS INGREDIENTS APIPHARMACEUTICALS RAW MATERIAL FOR PHARMAINDUSTRIES GRADE- PRODUCT NAME SELEXIPAG","address":"ALEMBIC ROAD","city":"GUJARAT","supplier":"ALEMBIC PHARMACEUTICALS LIMITED","supplierCountry":"INDIA","foreign_port":"MOSCOW","customer":"TO THE ORDER OF","customerCountry":"RUSSIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"232000","totalValueFC":"22565.2","currency":"USD","unitRateINR":18843625,"date":"24-Apr-2024","totalValueINR":"1884362.5","totalValueInUsd":"22565.2","indian_port":"Ahmedabad Air","hs_no":"29181990","bill_no":"9357693","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Ahmedabad Air","supplierAddress":"ALEMBIC ROAD, GUJARAT","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716834600,"product":"SELEXIPAG","address":"MSN HOUSE, PLOT NO. C-24,","city":"HYDERABAD. AP","supplier":"MSN LABORATORIES","supplierCountry":"INDIA","foreign_port":"ATHENS","customer":"PHARMATHEN SA","customerCountry":"GREECE","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"350000","totalValueFC":"34600.9","currency":"USD","unitRateINR":28841330,"date":"28-May-2024","totalValueINR":"2884133","totalValueInUsd":"34600.9","indian_port":"Hyderabad Air","hs_no":"29359090","bill_no":"1231036","productDescription":"API","marketType":"REGULATED MARKET","country":"GREECE","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"MSN HOUSE, PLOT NO. C-24,, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727289000,"product":"SELEXIPAG (EXPORT INVOICE NO. 6124010347, DATE: 23.09.2024)","address":"SYNO.257 258\/1, DNO.11-6\/56,","city":"VILLAGE BALANGAR POST HYDERABAD","supplier":"LEE PHARMA","supplierCountry":"INDIA","foreign_port":"SHEREMETYEVO","customer":"MPC ALIUM LLC","customerCountry":"RUSSIA","quantity":"0.66","actualQuantity":"660.64","unit":"GMS","unitRateFc":"17876.3","totalValueFC":"140799.4","currency":"INR","unitRateINR":17860.199261322352,"date":"26-Sep-2024","totalValueINR":"11799162.04","totalValueInUsd":"140799.4","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"4368704","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"RUSSIA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"SYNO.257 258\/1, DNO.11-6\/56,, VILLAGE BALANGAR POST HYDERABAD","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1731263400,"product":"SELEXIPAG (FORM-P)","address":"PLOT NO.C-24, MNS HOUSE,","city":"HYDERABAD, AP.","supplier":"MAITHRI DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"HANOI - NOIBAI","customer":"VINH PHUC PHARMACEUTICAL","customerCountry":"VIETNAM","quantity":"0.02","actualQuantity":"20","unit":"GMS","unitRateFc":"400","totalValueFC":"7878.3","currency":"USD","unitRateINR":33241.650000000001,"date":"11-Nov-2024","totalValueINR":"664833","totalValueInUsd":"7878.3","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"5518828","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"VIETNAM","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.C-24, MNS HOUSE,, HYDERABAD, AP.","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1633113000,"product":"(N.C.V) SELEXIPAG (JNJ-67896049-AAA) REF.STD. ACETAMIDE ,2-[4-[(5,6-DIPHENYL-2-PYRIZINYL)(1-METHYLETHYL)AMINO]BUTOXY]-N-","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"UNITED KINGDOM","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"0.3","unit":"GMS","unitRateFc":"286","totalValueFC":"101.3","currency":"EUR","unitRateINR":"25296.7","date":"02-Oct-2021","totalValueINR":"7589.01","totalValueInUsd":"101.3","indian_port":"BOMBAY AIR","hs_no":"29359090","bill_no":"5676815","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686767400,"product":"(N.C.V) JNJ-67896049-AAA REF STD OF SELEXIPAG ACETAMIDE-2[4-[5,6-DIPHENYL-2-PYRAZINYL)(1-METHLETHYL)AMINO]BUTOXY]-N-(ME","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"UNITED KINGDOM","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"1.5","unit":"GMS","unitRateFc":"286","totalValueFC":"468.9","currency":"EUR","unitRateINR":"25697.2","date":"15-Jun-2023","totalValueINR":"38545.409","totalValueInUsd":"468.9","indian_port":"BOMBAY AIR","hs_no":"29359090","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"}]

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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ABOUT THIS PAGE

Selexipag Manufacturers

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

Selexipag Suppliers

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

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

Selexipag USDMF

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

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

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

Selexipag KDMF

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

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

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

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

Selexipag WC

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

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

Selexipag 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 Selexipag as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Selexipag GMP

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

Selexipag CoA

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

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

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

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DEVELOPMENTS

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FINISHED DOSAGE FORMULATIONS

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39 FDA Orange Book

18 Europe

8 Canada

20 Australia

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EXCIPIENTS BY APPLICATIONS

42 Coating Systems & Additives

40 Fillers, Diluents & Binders

19 Direct Compression

17 Controlled & Modified Release

14 Chewable & Orodispersible Aids

14 Taste Masking

10 Co-Processed Excipients

9 Film Formers & Plasticizers

9 Disintegrants & Superdisintegrants

8 Lubricants & Glidants

6 Thickeners and Stabilizers

6 Granulation

5 Parenteral

5 Empty Capsules

5 Coloring Agents

4 Vegetarian Capsules

4 API Stability Enhancers

3 Solubilizers

3 Emulsifying Agents

3 Topical

1 Rheology Modifiers

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