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Chemistry

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Also known as: 202825-46-5, Safinamide mesilate, (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamide methanesulfonate, Pnu-151774e, Nw-1015, Safinamide (mesylate)
Molecular Formula
C18H23FN2O5S
Molecular Weight
398.5  g/mol
InChI Key
YKOCHIUQOBQIAC-YDALLXLXSA-N
FDA UNII
YS90V3DTX0

Safinamide Mesylate
1 2D Structure

Safinamide Mesylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methylamino]propanamide;methanesulfonic acid
2.1.2 InChI
InChI=1S/C17H19FN2O2.CH4O3S/c1-12(17(19)21)20-10-13-5-7-16(8-6-13)22-11-14-3-2-4-15(18)9-14;1-5(2,3)4/h2-9,12,20H,10-11H2,1H3,(H2,19,21);1H3,(H,2,3,4)/t12-;/m0./s1
2.1.3 InChI Key
YKOCHIUQOBQIAC-YDALLXLXSA-N
2.1.4 Canonical SMILES
CC(C(=O)N)NCC1=CC=C(C=C1)OCC2=CC(=CC=C2)F.CS(=O)(=O)O
2.1.5 Isomeric SMILES
C[C@@H](C(=O)N)NCC1=CC=C(C=C1)OCC2=CC(=CC=C2)F.CS(=O)(=O)O
2.2 Other Identifiers
2.2.1 UNII
YS90V3DTX0
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (s)-2-((4-(3-fluorobenzoxy)benzyl)amino)propanamide

2. 2-(4-(3-fluorobenzyloxy)benzylamino)propionamide

3. Fbap Methanesulfonate

4. Fce 26743

5. Fce 28073

6. Fce-26743

7. Fce-28073

8. Nw-1015

9. Pnu 151774e

10. Pnu-151774e

11. Safinamide

12. Safinamide Methanesulfonate

13. Xadago

2.3.2 Depositor-Supplied Synonyms

1. 202825-46-5

2. Safinamide Mesilate

3. (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamide Methanesulfonate

4. Pnu-151774e

5. Nw-1015

6. Safinamide (mesylate)

7. Safinamide Methanesulfonate

8. Pnu 151774e

9. Safinamide Mesylate [usan]

10. Fce-28073

11. Nw 1015

12. Safinamide Methansulfonate

13. Ys90v3dtx0

14. Propanamide, 2-[[[4-[(3-fluorophenyl)methoxy]phenyl]methyl]amino]-, (2s)-, Methanesulfonate (1:1)

15. 202825-46-5 (mesylate)

16. Safinamide Mesilate (jan)

17. Safinamide Mesylate (usan)

18. Safinamide Mesilate [jan]

19. (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)-amino)propanamide Methanesulfonate

20. Chembl48582

21. (s)-2-[[4-[(3-fluorobenzyl)oxy]benzyl]amino]propanamide Methanesulfonate

22. Unii-ys90v3dtx0

23. Fce-28073(r-isomer)

24. Safinamidemesylate

25. Equfina (tn)

26. Xadago (tn)

27. Safinamide Mesylate Salt

28. Emd 1195686 Mesylate

29. Mls006010740

30. Schembl1665715

31. Dtxsid80942414

32. Hms3884o17

33. Safinamide Mesylate (fce28073)

34. Amy38833

35. Bcp16018

36. Ex-a2640

37. Hy-70057a

38. Mfcd15145475

39. S1472

40. Safinamide Mesilate [who-dd]

41. Akos015902297

42. Ccg-268636

43. Safinamide Methanesulfonate [mi]

44. Safinamide Mesylate [orange Book]

45. Ac-27739

46. As-75602

47. Pnu-151774e,fce28073

48. Smr004701699

49. Safinamide Mesylate Salt, >=98% (hplc)

50. Cs-0006742

51. Sw219452-1

52. D10191

53. J-013174

54. Q27294690

55. (s)-2[4-(3-fluorobenzyloxy)benzylamino]propanamide Methanesulfonate

56. (s)-(+)-2-(4-(3-fluorobenzyloxy) Benzylamino)propanamide, Methanesulfonate

57. (s)-2-((4-((3-fluorobenzyl)oxy)benzyl)amino)propanamidemethanesulfonate

58. (s)-2-[4-(3-fluorobenzyloxy)benzylamino]propanamide Methanesulfonate

59. (2s)-2-[[4-[(3-fluorophenyl)methoxy]phenyl]methylamino]propanamide;methanesulfonic Acid

60. Propanamide, 2-(((4-((3-fluorophenyl)methoxy)phenyl)methyl)amino)-, (s)-, Monomethanesulfonate

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 398.5 g/mol
Molecular Formula C18H23FN2O5S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count7
Rotatable Bond Count7
Exact Mass398.13117117 g/mol
Monoisotopic Mass398.13117117 g/mol
Topological Polar Surface Area127 Ų
Heavy Atom Count27
Formal Charge0
Complexity438
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Xadago is indicated for the treatment of adult patients with idiopathic Parkinsons disease (PD) as add-on therapy to a stable dose of Levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.


5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
Monoamine Oxidase Type B Inhibitor [EPC]; Monoamine Oxidase-B Inhibitors [MoA]; Breast Cancer Resistance Protein Inhibitors [MoA]
5.2 ATC Code

N04B


API SUPPLIERS

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Polpharma

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Biophore India Pharmaceuticals Pvt...

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LGM Pharma

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Metrochem API Private Limited

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Suanfarma

Spain

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ZACH System SA

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HRV Global Life Sciences

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MSN Laboratories

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MSN Laboratories

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Solara Active Pharma Sciences

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Merck Group

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Merck Group

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GDUFA

DMF Review : N/A

Rev. Date :

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DMF Number : 34164

Submission : 2019-09-30

Status : Active

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DMF Review : Complete

Rev. Date : 2020-11-05

Pay. Date : 2020-09-28

DMF Number : 35201

Submission : 2020-09-28

Status : Active

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Biophore

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euroPLX 86 Munich
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euroPLX 86 Munich
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DMF Review : Complete

Rev. Date : 2020-11-05

Pay. Date : 2020-09-26

DMF Number : 34399

Submission : 2020-02-13

Status : Active

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DMF Review : Complete

Rev. Date : 2020-10-14

Pay. Date : 2020-09-09

DMF Number : 35179

Submission : 2020-09-10

Status : Active

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euroPLX 86 Munich
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DMF Number : 32225

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Merck Kgaa

Germany

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Merck Kgaa

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euroPLX 86 Munich
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DMF Review : Complete

Rev. Date : 2020-10-15

Pay. Date : 2020-08-12

DMF Number : 34628

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euroPLX 86 Munich
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DMF Review : Complete

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Safinamide Mesylate

Registration Number : 304MF10141

Registrant's Address : Z. I. La Croix Cadeau, C. S. 10079,49242 AVRILLE Cedex,France

Initial Date of Registration : 2022-10-12

Latest Date of Registration : 2023-10-04

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Merck KGaA

Germany
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Merck KGaA

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Safinamide Mesylate

Registration Number : 230MF10101

Registrant's Address : Frankfurter Strasse 250 64293 Darmstadt Germany

Initial Date of Registration : 2018-08-02

Latest Date of Registration : 2018-08-02

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Polpharma

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Safinamide Mesylate

About the Company : Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the c...

Polpharma API. European CDMO partner and API manufacturer since 1951. Poland-based CDMO and API producer, delivering products to pharmaceutical companies worldwide. Aiming at the continuous development of Polpharma and caring for the future of patients, business partners and our employees, we are launching a specialized facility for the R&D and Production of HPAPI with an OEL value of 10 ng/m3 (OEB 6). The HP API investment includes separate process laboratories (PDL), analytical laboratories (ADL) with the possibility of performing QC analyses, and a GMP kilo-lab production line with volume up to 1.5 kg with potential volume increase.
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Virtual BoothBiophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Safinamide Mesylate

About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...

Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-approved API manufacturing facilities, a dedicated intermediate facility, and a R&D laboratory housing 400 scientists, Biophore has positioned itself as a global leader among API companies. It consistently ranks among the top 10 US DMF filers and has obtained over 150 patents worldwide in process and polymorph areas. Biophore's facilities have an impressive track record of successful audits by regulatory bodies such as USFDA, EMEA, ANVISA, COFEPRIS, and WHO GMP.
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LGM Pharma

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Safinamide Mesylate

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, analytical method development and testing, and commercial manufacturing. LGM Pharma offers custom API synthesis, analytical development, and regulatory services. With a network of over 300 accredited CGMP manufacturing partners, LGM provides unparalleled supply chain security. And, with over 100,000 square feet of FDA-inspected cGMP manufacturing and warehouse capacity, LGM Pharma provides a one-stop solution for solid dose, powder, semi-solid and liquid drugs.
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Safinamide Mesylate

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Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product ...

Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product groups and has been approved by ISO 9001-2015, USFDA, WHO GMP, Cofepris & Japanese authorities. Metrochem’s in-depth industry knowledge, & hi-tech & advanced infrastructure, helps it provide quality products to its customers. Note: None of the products will be supplied to the countries where this could conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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Suanfarma

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Safinamide Mesylate

About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indu...

Suanfarma founded in 1993, is a B2B life science partner committed to health & innovation by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical industry innovatively & sustainably. Backed by a robust global network of 12 strategically located local offices, we cater to the needs of over 400 active customers in 70+ countries. At Suanfarma we offer our CDMO capacity for fermentation & chemical synthesis projects, offering a One Stop Shop service with a solid track record, & which allows us to achieve success in the development, scaling, manufacturing, & commercialization of an API, either innovative or generic.
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Safinamide Mesylate

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.
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07

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Safinamide Mesylate

About the Company : Beijing Fukangren Biopharmaceutical Technology Co., Ltd. started its drug R&D service in 1999 and is the CRO company with the longest continuous service time in China. Fukangren no...

Beijing Fukangren Biopharmaceutical Technology Co., Ltd. started its drug R&D service in 1999 and is the CRO company with the longest continuous service time in China. Fukangren now has 3 pharmaceutical R&D centers, 1 clinical R&D center, 4 API production bases and 1 preparation production base, forming an end-to-end CDMO service system that can provide customers with drug R&D and production. The development of high-end formulations is a major advantage of Fukangren. Among them, multiple platform projects such as sustained and controlled release formulations.
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Safinamide Mesylate

About the Company : Brother Enterprises Holding Co., Ltd. was founded in 1991 and is headquartered in Haining City, Zhejiang Province, China. With over 30 years of experience, Brother Enterprises has ...

Brother Enterprises Holding Co., Ltd. was founded in 1991 and is headquartered in Haining City, Zhejiang Province, China. With over 30 years of experience, Brother Enterprises has grown into an international chemical group, covering four business divisions – leather chemicals, vitamins, spices, and active pharmaceutical ingredients. There are also several wholly owned subsidiaries. Brother Enterprises has four manufacturing plants: three in China (Zhejiang Province, Jiangsu Province, and Jiangxi Province) and one in Newcastle, South Africa.
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Hetero Drugs

India
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Hetero Drugs

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Safinamide Mesylate

About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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Safinamide Mesylate

About the Company : Optimus is one of the fastest-growing pharmaceutical companies with 16 years of experience in providing the best quality of API, Intermediates & Finished formulations in Global mar...

Optimus is one of the fastest-growing pharmaceutical companies with 16 years of experience in providing the best quality of API, Intermediates & Finished formulations in Global markets. Our aim from day one has been to provide and ensure better healthcare across the globe through our research, Innovations, affordable products & manufacturing excellence. Optimus was established to provide quality & affordable pharmaceutical products in the global markets.
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AP","supplier":"OPTIMUS DRUGS PRIVATE ","supplierCountry":"INDIA","foreign_port":"ISTANBUL","customer":"TO THE ORDER OF","customerCountry":"TURKEY","quantity":"3.00","actualQuantity":"3","unit":"KGS","unitRateFc":"1800","totalValueFC":"5300.7","currency":"USD","unitRateINR":146666.66666666666,"date":"04-Sep-2023","totalValueINR":"440000","totalValueInUsd":"5300.7","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"3702690","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"TURKEY","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"PLOT NO.131,3RD FLOOR,NARMADA, HYDERABAD. AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705948200,"product":"SAFINAMIDE MESYLATE IN-HOUSE","address":"FLAT.203,SATYA SAI RESY.PLOT","city":"ROAD,AMEERPET, HYDERABAD,AP","supplier":"NIFTY LABS","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"M\/S:PENTA PHARMA EGYPT,","customerCountry":"EGYPT","quantity":"16.00","actualQuantity":"16","unit":"KGS","unitRateFc":"3100","totalValueFC":"49070.1","currency":"USD","unitRateINR":254893.68124999999,"date":"23-Jan-2024","totalValueINR":"4078298.9","totalValueInUsd":"49070.1","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"6961751","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"FLAT.203,SATYA SAI RESY.PLOT, ROAD,AMEERPET, HYDERABAD,AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727116200,"product":"SAFINAMIDE MESYLATE","address":"HOSTER LABS PRIVATE LIMITED","city":"HYDERABAD","supplier":"HOSTER LABS PRIVATE LIMITED","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"JP BIO CORPRATIONS","customerCountry":"REPUBLIC OF KOREA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"1350","totalValueFC":"2640.1","currency":"USD","unitRateINR":110623.38499999999,"date":"24-Sep-2024","totalValueINR":"221246.77","totalValueInUsd":"2640.1","indian_port":"Hyderabad Air","hs_no":"29242990","bill_no":"4286779","productDescription":"API","marketType":"REGULATED MARKET","country":"REPUBLIC OF KOREA","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"HOSTER LABS PRIVATE LIMITED, HYDERABAD","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q1","strtotime":1612463400,"product":"SAFINAMIDE METHANESULFONATE","address":"802, BLOCK-A, ALPINE HEIGHTS GULMOHAR AVENUE, SOMAJIGUDA","city":"HYDERABAD, A.P.","supplier":"POLPHARMA","supplierCountry":"POLAND","foreign_port":"WARSAW","customer":"TIEFENBACHER API + INGREDIENTS GMBH","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"0.5","unit":"KGS","unitRateFc":"4400","totalValueFC":"2698.4","currency":"EUR","unitRateINR":"392920","date":"05-Feb-2021","totalValueINR":"196460","totalValueInUsd":"2698.4","indian_port":"HYDERABAD AIR","hs_no":"29349990","bill_no":"2626969","productDescription":"API","marketType":"REGULATED MARKET","country":"POLAND","selfForZScoreResived":"Pharma Grade","supplierPort":"WARSAW","supplierAddress":"","customerAddress":"802, BLOCK-A, ALPINE HEIGHTS GULMOHAR AVENUE, SOMAJIGUDA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1712601000,"product":"SAFINAMIDE MESYLATE. B\/N: D5431-22-004 (3 KG) & D5431-22-008M1 (2 KG) MFG. DT. 08\/05\/2022 RETEST DT. 04\/2025 (3 KG) MFG.","address":"PLOT NO.5222, PHASE- IV,","city":"AHMEDABAD -","supplier":"ZHEJIANG HUAHAI PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"UNISON PHARMACEUTICALS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"1200","totalValueFC":"6060.5","currency":"USD","unitRateINR":"101220","date":"09-Apr-2024","totalValueINR":"506100","totalValueInUsd":"6060.5","indian_port":"Ahmedabad Air","hs_no":"29242990","bill_no":"2947206","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"XUNQIAO,LINHAI ,ZHEJIANG 317024 CHISDNF CHINA","customerAddress":"PLOT NO.5222, PHASE- IV,"}]
05-Feb-2021
24-Sep-2024
KGS
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Average Price (USD/KGS)

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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INTERMEDIATES SUPPLIERS

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01

Compamed
Not Confirmed
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Compamed
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CAS Number : 66742-57-2

End Use API : Safinamide Mesylate

About The Company : Jinan Xinke Pharmaceutical Science and Technology Co., Ltd. (XKPHARM) is an innovation driven company, headquartered in Jinan city, Shandong province, China and...

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02

Compamed
Not Confirmed
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Compamed
Not Confirmed
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CAS Number : 33208-99-0

End Use API : Safinamide Mesylate

About The Company : Jinan Xinke Pharmaceutical Science and Technology Co., Ltd. (XKPHARM) is an innovation driven company, headquartered in Jinan city, Shandong province, China and...

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Europe

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01

Zambon SpA,

Switzerland
Compamed
Not Confirmed
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Zambon SpA,

Switzerland
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Compamed
Not Confirmed

safinamidmesilat

Brand Name : Xadago

Dosage Form : FILM COATED PILL

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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02

Zambon SpA,

Switzerland
Compamed
Not Confirmed
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Zambon SpA,

Switzerland
arrow
Compamed
Not Confirmed

safinamidmesilat

Brand Name : Xadago

Dosage Form : FILM COATED PILL

Dosage Strength : 50 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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03

ZAMBON SpA

Switzerland
Compamed
Not Confirmed
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ZAMBON SpA

Switzerland
arrow
Compamed
Not Confirmed

Safinamide Mesylate

Brand Name : Xadago

Dosage Form : Safinamide 100Mg 30 Joined' Oral Use

Dosage Strength : 30 cpr riv 100 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

ZAMBON SpA

Switzerland
Compamed
Not Confirmed
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ZAMBON SpA

Switzerland
arrow
Compamed
Not Confirmed

Safinamide Mesylate

Brand Name : Xadago

Dosage Form : Safinamide 50Mg 30 Joined' Oral Use

Dosage Strength : 30 cpr riv 50 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

Zambon SpA

Switzerland
Compamed
Not Confirmed
arrow

Zambon SpA

Switzerland
arrow
Compamed
Not Confirmed

Safinamide Mesylate

Brand Name : Xadago

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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06

Zambon SpA

Switzerland
Compamed
Not Confirmed
arrow

Zambon SpA

Switzerland
arrow
Compamed
Not Confirmed

Safinamide Mesylate

Brand Name : Xadago

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

Zambon SpA

Switzerland
Compamed
Not Confirmed
arrow

Zambon SpA

Switzerland
arrow
Compamed
Not Confirmed

Safinamide Mesylate

Brand Name : Xadago

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 50 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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08

Compamed
Not Confirmed
arrow
arrow
Compamed
Not Confirmed

Safinamide

Brand Name : Xadago

Dosage Form : Film-Coated Tablets

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

Compamed
Not Confirmed
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arrow
Compamed
Not Confirmed

Safinamide

Brand Name : Xadago

Dosage Form : Film-Coated Tablets

Dosage Strength : 100mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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10

Compamed
Not Confirmed
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arrow
Compamed
Not Confirmed

Safinamide

Brand Name : Xadago

Dosage Form : Film-Coated Tablets

Dosage Strength : 50mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Australia

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01

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

safinamide

Brand Name : Xadago

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

euroPLX 86 Munich
Not Confirmed
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euroPLX 86 Munich
Not Confirmed

safinamide

Brand Name : Xadago

Dosage Form :

Dosage Strength :

Packaging : 30

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - EQ 100MG BASE

USFDA APPLICATION NUMBER - 207145

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DOSAGE - TABLET;ORAL - EQ 50MG BASE

USFDA APPLICATION NUMBER - 207145

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API Stability Enhancers

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