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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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Chemistry

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Also known as: 103177-37-3, Azlaire, Ono-1078, Pranlukast hydrate, Ono 1078, Sb 205312
Molecular Formula
C27H23N5O4
Molecular Weight
481.5  g/mol
InChI Key
NBQKINXMPLXUET-UHFFFAOYSA-N
FDA UNII
TB8Z891092

Pranlukast Hydrate
Pranlukast is a cysteinyl leukotriene receptor-1 antagonist. It antagonizes or reduces bronchospasm caused, principally in asthmatics, by an allergic reaction to accidentally or inadvertently encountered allergens.
1 2D Structure

Pranlukast Hydrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
N-[4-oxo-2-(2H-tetrazol-5-yl)chromen-8-yl]-4-(4-phenylbutoxy)benzamide
2.1.2 InChI
InChI=1S/C27H23N5O4/c33-23-17-24(26-29-31-32-30-26)36-25-21(23)10-6-11-22(25)28-27(34)19-12-14-20(15-13-19)35-16-5-4-9-18-7-2-1-3-8-18/h1-3,6-8,10-15,17H,4-5,9,16H2,(H,28,34)(H,29,30,31,32)
2.1.3 InChI Key
NBQKINXMPLXUET-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1=CC=C(C=C1)CCCCOC2=CC=C(C=C2)C(=O)NC3=CC=CC4=C3OC(=CC4=O)C5=NNN=N5
2.2 Other Identifiers
2.2.1 UNII
TB8Z891092
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 8-(4 (4-phenylbutoxy)benzoyl)amino-2-(tetrazol-5'-yl)-4-oxo-4h-1-benzopyran

2. Ono 1078

3. Ono-1078

4. Ono-rs 411

5. Ono-rs-411

6. Sb 205312

2.3.2 Depositor-Supplied Synonyms

1. 103177-37-3

2. Azlaire

3. Ono-1078

4. Pranlukast Hydrate

5. Ono 1078

6. Sb 205312

7. Ccn 00401

8. Rs 411

9. Pranlukast (inn)

10. N-[4-oxo-2-(2h-tetrazol-5-yl)chromen-8-yl]-4-(4-phenylbutoxy)benzamide

11. Onon

12. Ono-rs-411

13. 4-oxo-8-(4-(4-phenylbutoxy)benzoylamino)-2-(tetrazol-5-yl)-4h-1-benzopyran

14. Chembl21333

15. N-(4-oxo-2-(1h-tetrazol-5-yl)-4h-chromen-8-yl)-4-(4-phenylbutoxy)benzamide

16. Ccn-00401

17. Rs-411

18. Tb8z891092

19. Ncgc00181765-01

20. Sb-205312

21. Pranlukast [inn]

22. N-(4-oxo-2-(1h-tetrazol-5-yl)-4h-1-benzopyran-8-yl)-p-(4-phenylbutoxy)benzamide

23. N-(4-oxo-2-(2h-tetrazol-5-yl)-4h-chromen-8-yl)-4-(4-phenylbutoxy)benzamide

24. 8-[4(4-phenylbutoxy)benzoyl]amino-2-(5-tetrazolyl)-4-oxo-4h-1-benzopyran;8-[4(4-phenylbutoxy)benzoyl]amino-2-(5-tetrazolyl)-4-oxo-4h-1-benzopyran

25. N-[4-oxo-2-(1h-tetrazol-5-yl)-4h-1-benzopyran-8-yl]-p-(4-phenylbutoxy)benzamide;n-[4-oxo-2-(1h-tetrazol-5-yl)-4h-1-benzopyran-8-yl]-p-(4-phenylbutoxy)benzamide

26. Azlaire (tn)

27. Pranlukast [inn:ban]

28. Sr-05000001474

29. Unii-tb8z891092

30. N-[4-oxo-2-(1h-tetrazol-5-yl)-4h-chromen-8-yl]-4-(4-phenylbutoxy)benzamide

31. N-[4-oxo-2-(2h-tetrazol-5-yl)-1-benzopyran-8-yl]-4-(4-phenylbutoxy)benzamide

32. Pranlukast [mi]

33. Pranlukast [mart.]

34. Schembl3693

35. Dsstox_cid_23782

36. Dsstox_rid_80074

37. Pranlukast [who-dd]

38. Dsstox_gsid_43782

39. Mls006010078

40. Gtpl3634

41. Ono Rs-411

42. Dtxsid3043782

43. Schembl18058592

44. Chebi:94810

45. Hms2089h16

46. Hms3650a14

47. Hms3714e03

48. Bcp04577

49. Hy-b0290

50. Zinc1542146

51. Tox21_112952

52. Ac-696

53. Bdbm50023198

54. Mfcd00864631

55. Akos015967342

56. Ccg-220661

57. Db01411

58. Sb19080

59. N-[4-oxo-2-(1h-tetrazol-5-yl)-4h-1-benzopyran-8-yl]-4-(4-phenylbutoxy)benzamide

60. As-15105

61. Smr004701229

62. Cas-103177-37-3

63. Ft-0652673

64. P2115

65. C71133

66. D08408

67. Ab01275471-01

68. 177p373

69. L013134

70. Q7238392

71. Sr-05000001474-1

72. Sr-05000001474-2

73. Sr-05000001474-3

74. Brd-k97045029-001-01-9

75. Brd-k97045029-001-04-3

76. 8-[4-(4-phenylbutyloxy)benzoyl]amino-2-(tetrazol-5-yl)-4-oxo-4h-1-benzopyran

77. Benzamide, N-(4-oxo-2-(1h-tetrazol-5-yl)-4h-1-benzopyran-8-yl)-4-(4-phenylbutoxy)-

78. N-[4-oxo-2-(1h-tetrazol-5-yl)-4h-1-benzopyran-8-yl]-4(4-phenylbutoxy)benzamide

79. N-[4-oxo-2-(1h-tetrazol-5-yl)-4h-chromen-8-yl]-4-(4-phenyl-butoxy)-benzamide

80. Benzamide, N-(4-oxo-2-(2h-tetrazol-5-yl)-4h-1-benzopyran-8-yl)-4-(4-phenylbutoxy)-

81. Knt

82. N-[4-oxo-2-(1h-tetrazol-5-yl)-4h-chromen-8-yl]-4-(4-phenyl-butoxy)-benzamide (ono-rs-411)

83. N-[4-oxo-2-(1h-tetrazol-5-yl)-4h-chromen-8-yl]-4-(4-phenyl-butoxy)-benzamide(ono-rs-411)

2.4 Create Date
2005-03-25
3 Chemical and Physical Properties
Molecular Weight 481.5 g/mol
Molecular Formula C27H23N5O4
XLogP34.2
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count9
Exact Mass481.17500423 g/mol
Monoisotopic Mass481.17500423 g/mol
Topological Polar Surface Area119 Ų
Heavy Atom Count36
Formal Charge0
Complexity778
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Used as an adjunct to the standard therapy of inhaled steroids with inhaled long- and/or short-acting beta-agonists.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Pranlukast is a cysteinyl leukotriene receptor-1 antagonist.


5.2 MeSH Pharmacological Classification

Leukotriene Antagonists

A class of drugs designed to prevent leukotriene synthesis or activity by blocking binding at the receptor level. (See all compounds classified as Leukotriene Antagonists.)


Anti-Asthmatic Agents

Drugs that are used to treat asthma. (See all compounds classified as Anti-Asthmatic Agents.)


5.3 ATC Code

R - Respiratory system

R03 - Drugs for obstructive airway diseases

R03D - Other systemic drugs for obstructive airway diseases

R03DC - Leukotriene receptor antagonists

R03DC02 - Pranlukast


5.4 Metabolism/Metabolites

Hepatic


5.5 Mechanism of Action

Pranlukast selectively antagonizes leukotriene D4 (LTD4) at the cysteinyl leukotriene receptor, CysLT1, in the human airway. Pranlukast inhibits the actions of LTD4 at the CysLT1 receptor, preventing airway edema, smooth muscle contraction, and enhanced secretion of thick, viscous mucus.


API SUPPLIERS

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Zhejiang Hengkang Pharmaceutical

China

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Zhejiang Hengkang Pharmaceutical

China

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Kyongbo Pharmaceutical Co., Ltd

South Korea

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Kyongbo Pharmaceutical Co., Ltd

South Korea

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Zhejiang Ausun Pharmaceutical

China

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Zhejiang Ausun Pharmaceutical

China

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Refarmed Chemicals

Switzerland

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Samhwa Biopharm

South Korea

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Samhwa Biopharm

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Eisai

Japan

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Eisai

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Polaris AI Pharma

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Polaris AI Pharma

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Eisai

Japan

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Eisai

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Pharmacostech

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Pharmacostech

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JDMF

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Virtual BoothZhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

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Pranlukast hydrate

Registration Number : 306MF10129

Registrant's Address : No. 11 Chengen Road, Pubagan Town, Sanmen, Zhejiang, China

Initial Date of Registration : 2024-09-25

Latest Date of Registration : 2024-09-25

Zhejiang Hengkang Pharmaceutical

02

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Pranlukast hydrate

Registration Number : 222MF10148

Registrant's Address : No. 1 Longxiang Road, Hairun Street, Sanmen, Zhejiang, China

Initial Date of Registration : 2010-04-28

Latest Date of Registration : 2010-04-28

Zhejiang Hengkang Pharmaceutical

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Pranlukast hydrate

Registration Number : 230MF10044

Registrant's Address : 2-36-1 Kanda Jimbocho, Chiyoda-ku, Tokyo

Initial Date of Registration : 2018-03-14

Latest Date of Registration : 2018-03-14

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Pranlukast hydrate (for manufacturing purposes only)

Registration Number : 223MF10125

Registrant's Address : Sarkhej-Dholka Road, Bhat, Ahmedabad-382 210, Gujarat, INDIA

Initial Date of Registration : 2011-07-28

Latest Date of Registration : 2023-03-23

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PRANLUKAST HYDRATE (JP)

Registration Number : 228MF10105

Registrant's Address : No. 2066 Tangkou Road, Economy and Technology Development Zone, Hefei, Anhui Province...

Initial Date of Registration : 2016-06-06

Latest Date of Registration : 2019-05-08

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Japanese Pharmacopoeia Pranlukast Hydrate

Registration Number : 230MF10049

Registrant's Address : Ramky Pharma City (SEZ), Plot Nos. 96,97,98,124&126,Parawada-531 019,Visakhapatnam Di...

Initial Date of Registration : 2018-03-30

Latest Date of Registration : 2020-02-13

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Japanese Pharmacopoeia Pranlukast Hydrate (P)

Registration Number : 302MF10035

Registrant's Address : Visakha Pharmacity Limited (SEZ), Plot Nos. 96,97,98,124&126, Parawada-531 019, Anaka...

Initial Date of Registration : 2020-03-16

Latest Date of Registration : 2026-04-09

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Pranlukast hydrate (for manufacturing purposes only)

Registration Number : 303MF10001

Registrant's Address : 174, Sirok-ro, Asan-si, Chungcheongnam-do, KOREA

Initial Date of Registration : 2021-01-05

Latest Date of Registration : 2021-01-05

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Pranlukast hydrate

Registration Number : 303MF10068

Registrant's Address : 47, Jeyakdanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Republic of Korea

Initial Date of Registration : 2021-04-19

Latest Date of Registration : 2025-01-09

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Pranlukast hydrate (for manufacturing purposes only)

Registration Number : 224MF10149

Registrant's Address : 25, Barangongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea

Initial Date of Registration : 2012-07-31

Latest Date of Registration : 2020-08-18

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KDMF

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Franlucast Luggage

Registrant Name : Bansen Co., Ltd.

Registration Date : 2016-01-08

Registration Number : 20160108-171-I-474-06

Manufacturer Name : Zhejiang Hengkang Pharmaceut...

Manufacturer Address : No.1 Longxiang Road, Hairun Street, Sanmen, Zhejiang, China

Zhejiang Hengkang Pharmaceutical

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Virtual BoothZhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

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Franlucast Luggage

Registrant Name : Ace Biopharm Co., Ltd.

Registration Date : 2020-11-13

Registration Number : 20160108-171-I-474-06(1)

Manufacturer Name : Zhejiang Hengkang Pharmaceut...

Manufacturer Address : No.1 Longxiang Road, Hairun Street, Sanmen, Zhejiang, China

Zhejiang Hengkang Pharmaceutical

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Pranlukast Hydrate

Registrant Name : Ace Biopharm Co., Ltd.

Registration Date : 2018-08-09

Registration Number : 20180809-171-I-571-08

Manufacturer Name : Chongqing Shenghuaxi Pharmac...

Manufacturer Address : No.8, Jiangqiao Road, Nan'an District, Chongqing, China

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Franlucast Luggage

Registrant Name : Sam-O Pharmaceutical Co., Ltd.

Registration Date : 2022-06-20

Registration Number : 20180809-171-I-571-08(1)

Manufacturer Name : Chongqing Shenghuaxi Pharmac...

Manufacturer Address : No.8, Jiangqiao Road, Nan'an District, Chongqing, China

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Franlucast Luggage

Registrant Name : Dong-A ST Co., Ltd.

Registration Date : 2013-09-12

Registration Number : 20130912-171-I-213-05

Manufacturer Name : Fujimoto Chemicals Co., Ltd....

Manufacturer Address : 1-24, Rinkai-cho, Izumiohtsu-city, Osaka, Japan

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Korea Biochem Pharm

South Korea
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Korea Biochem Pharm

South Korea
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Franlucast Luggage

Registrant Name : Korea Biochem Pharmaceutical Co., Ltd.

Registration Date : 2025-01-10

Registration Number : 20250110-171-I-691-09

Manufacturer Name : Korea Biochem Pharmaceutical...

Manufacturer Address : Korea Biochem Pharmaceutical Co., Ltd., 204, Sandan-gil, Jeonui-myeon, Sejong Special...

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Pharmacostech

South Korea
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Franlucast

Registrant Name : Pharmacostec Co., Ltd.

Registration Date : 2013-01-16

Registration Number : 20130116-171-I-269-04

Manufacturer Name : Pharmacostec Co., Ltd.

Manufacturer Address : 47, Jeyakdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

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Pharmacostech

South Korea
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Franlucast

Registrant Name : Pharmacostec Co., Ltd.

Registration Date : 2018-06-11

Registration Number : 20180611-171-I-570-07

Manufacturer Name : Pharmacostec Co., Ltd.

Manufacturer Address : 47, Jeyakdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

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Samhwa Biopharm

South Korea
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Samhwa Biopharm

South Korea
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Franlucast

Registrant Name : Samhwa Biopharm Co., Ltd.

Registration Date : 2012-11-28

Registration Number : 20121128-171-I-280-01

Manufacturer Name : Samhwa Biopharm Co., Ltd.

Manufacturer Address : 150 Hyeopnyeop-ro, Siheung-si, Gyeonggi-do

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Franlucast Luggage

Registrant Name : SG Biochem Co., Ltd.

Registration Date : 2025-10-31

Registration Number : 20251031-171-I-736-11

Manufacturer Name : Zhejiang Ausun Pharmaceutica...

Manufacturer Address : No.5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, Chi...

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Listed Suppliers

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01

  • fda
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Virtual BoothZhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.

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Digital Content Digital Content

Pranlukast Hydrate

About the Company : Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming ...

Established in 2004 and headquartered in Hangzhou, Hengkang established multiple factories, research and sales centers in Zhejiang, Shandong, and Henan. With facilities conforming to global API standards, along with professional R&D and marketing teams, Hengkang’s operations span major pharmaceutical markets such as China, Europe, the CIS region, Japan, and South Korea. Hengkang has established long-term and stable relationships with nearly 70 countries overseas and hundreds of domestic enterprises. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Zhejiang Hengkang Pharmaceutical

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Pranlukast Hemihydrate

About the Company : Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past six decades, we have been developing and manufacturing affordable ...

Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies in India. Over the past six decades, we have been developing and manufacturing affordable medicines for patients around the world. Our innovation-led drug discovery processes ensure the health and well-being of people around the world. Our enhanced investment in innovation and a strong track record in research and development have produced medical miracles that have changed lives and made a profound impact on real life.
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Polaris AI Pharma

South Korea
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Polaris AI Pharma

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Pranlukast hemihydrate

About the Company : Polaris AI Pharma is a dynamic company specializing in innovative pharmaceutical solutions. Leveraging cutting-edge AI technology, it focuses on drug discovery, development, and op...

Polaris AI Pharma is a dynamic company specializing in innovative pharmaceutical solutions. Leveraging cutting-edge AI technology, it focuses on drug discovery, development, and optimization to address unmet medical needs. Committed to advancing healthcare, Polaris AI Pharma combines scientific expertise with digital innovation to deliver impactful treatments.
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Refarmed Chemicals

Switzerland
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Pranlukast

About the Company : Refarmed Chemicals is a fully integrated Swiss-based marketing company with extensive experience in the generics industry. Our global market activity and strategic offices located ...

Refarmed Chemicals is a fully integrated Swiss-based marketing company with extensive experience in the generics industry. Our global market activity and strategic offices located in India and China give customers the benefit of our expertise in API sourcing, finished formulation and new product development, technical and regulatory support, supply chain logistics, out-licensing and other business development activities. Our presence in over 60 countries gives us a vast network to monitor the latest market developments.
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Samhwa Biopharm

South Korea
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Samhwa Biopharm

South Korea
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Pranlukast Hydrate

About the Company : Samhwa Biopharm Co., Ltd. is a South Korean pharmaceutical company specializing in the development and production of active pharmaceutical ingredients (APIs), excipients, and inter...

Samhwa Biopharm Co., Ltd. is a South Korean pharmaceutical company specializing in the development and production of active pharmaceutical ingredients (APIs), excipients, and intermediates. With a portfolio encompassing over 30 products, Samhwa Biopharm serves global markets, including Russia, Vietnam, and Colombia. The company operates manufacturing facilities in Gyeonggi-do, South Korea, and maintains a robust supply chain with partners in India. Samhwa Biopharm is committed to delivering high-quality pharmaceutical solutions to meet diverse therapeutic needs worldwide.
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pranlukast hydrate

About the Company : Founded in 2010, Ausun Pharmaceutical is a public company, specialized in high-tech. threshold Generic API Dev. & providing CDMO services. Ausun owns & operates 1 on-site R&D Cente...

Founded in 2010, Ausun Pharmaceutical is a public company, specialized in high-tech. threshold Generic API Dev. & providing CDMO services. Ausun owns & operates 1 on-site R&D Center & 1 Mfg. Site which has been certified by US FDA, JPMDA & EMA, supported by >550 highly trained professionals across departments & >200 scientists to bring high quality products to customers. More than 130 products/projects have been successfully developed since founded. Process Innovation, R&D Efficiency & Cost Effectiveness are Ausun's key competencies. Create Chemistry and to be the 1st Class Worldwide Pharmaceutical Corporation is our goal.
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Drugs in Development

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  • Development Update

Details:

Pranlukast Hydrate is a small molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Asthma.


Lead Product(s): Pranlukast Hydrate,R713R

Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 17, 2025

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AJU Pharm

Country
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AJU Pharm

Country
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Details : Pranlukast Hydrate is a small molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Asthma.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

November 17, 2025

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Details:

PRIC is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): PRIC,Pranlukast Hydrate

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Undisclosed

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 01, 2019

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02

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PEGS Boston Summit
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Details : PRIC is a drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Undisclosed

Upfront Cash : Inapplicable

February 01, 2019

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Details:

Pranlukast Hydrate is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Rhinitis, Allergic, Perennial.


Lead Product(s): Pranlukast Hydrate,Inapplicable

Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 27, 2012

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PEGS Boston Summit
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Details : Pranlukast Hydrate is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Rhinitis, Allergic, Perennial.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 27, 2012

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INTERMEDIATE SUPPLIERS

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  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAnlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.

CAS Number : 3360-41-6

End Use API : Pranlukast Hydrate

About The Company : Anlon Healthcare is a research-focused pharmaceutical manufacturer based in Rajkot, specializing in bulk drugs and intermediates. The company’s products compl...

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02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAnlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.

CAS Number : 30131-16-9

End Use API : Pranlukast Hydrate

About The Company : Anlon Healthcare is a research-focused pharmaceutical manufacturer based in Rajkot, specializing in bulk drugs and intermediates. The company’s products compl...

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03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAnlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.

CAS Number : 136450-06-1

End Use API : Pranlukast Hydrate

About The Company : Anlon Healthcare is a research-focused pharmaceutical manufacturer based in Rajkot, specializing in bulk drugs and intermediates. The company’s products compl...

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04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAnlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.

CAS Number : 70977-72-9

End Use API : Pranlukast Hydrate

About The Company : Anlon Healthcare is a research-focused pharmaceutical manufacturer based in Rajkot, specializing in bulk drugs and intermediates. The company’s products compl...

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05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAnlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.

CAS Number : 55408-10-1

End Use API : Pranlukast Hydrate

About The Company : Anlon Healthcare is a research-focused pharmaceutical manufacturer based in Rajkot, specializing in bulk drugs and intermediates. The company’s products compl...

Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAnlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.

CAS Number : 4830-93-7

End Use API : Pranlukast Hydrate

About The Company : Anlon Healthcare is a research-focused pharmaceutical manufacturer based in Rajkot, specializing in bulk drugs and intermediates. The company’s products compl...

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07

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CAS Number : 3360-41-6

End Use API : Pranlukast Hydrate

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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CAS Number : 30131-16-9

End Use API : Pranlukast Hydrate

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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CAS Number : 136450-06-1

End Use API : Pranlukast Hydrate

About The Company : Established in 2003 with small pilot plant and came in to commercial production in 2013 in the name of Allchem Laboratories, it is an independent privately owne...

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CAS Number : 110683-23-3

End Use API : Pranlukast Hydrate

About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...

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FDF Dossiers

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Pranlukast

Brand Name :

Dosage Form : Dry Syrup

Dosage Strength : 10%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Listed Dossiers

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Pranlukast

Brand Name :

Dosage Form : Dry Syrup

Dosage Strength : 10%

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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Pranlukast

Dosage : Dry Syrup

Dosage Strength : 10%

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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ABOUT THIS PAGE

Looking for 103177-37-3 / Pranlukast Hydrate API manufacturers, exporters & distributors?

Pranlukast Hydrate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Pranlukast Hydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pranlukast Hydrate manufacturer or Pranlukast Hydrate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pranlukast Hydrate manufacturer or Pranlukast Hydrate supplier.

API | Excipient name

Pranlukast Hydrate

Synonyms

103177-37-3, Azlaire, Ono-1078, Ono 1078, Sb 205312, Ccn 00401

Cas Number

103177-37-3

Unique Ingredient Identifier (UNII)

TB8Z891092

About Pranlukast Hydrate

Pranlukast is a cysteinyl leukotriene receptor-1 antagonist. It antagonizes or reduces bronchospasm caused, principally in asthmatics, by an allergic reaction to accidentally or inadvertently encountered allergens.

Pranlukast Hydrate Manufacturers

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

Pranlukast Hydrate Suppliers

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

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

Pranlukast Hydrate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Pranlukast Hydrate Drug Master File in Japan (Pranlukast Hydrate JDMF) empowers Pranlukast Hydrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Pranlukast Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Pranlukast Hydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Pranlukast Hydrate suppliers with JDMF on PharmaCompass.

Pranlukast Hydrate KDMF

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

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

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

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

Pranlukast Hydrate GMP

Pranlukast Hydrate 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 Pranlukast Hydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Pranlukast Hydrate GMP manufacturer or Pranlukast Hydrate GMP API supplier for your needs.

Pranlukast Hydrate CoA

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

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

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