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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
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)
| Molecular Weight | 481.5 g/mol |
|---|---|
| Molecular Formula | C27H23N5O4 |
| XLogP3 | 4.2 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 9 |
| Exact Mass | 481.17500423 g/mol |
| Monoisotopic Mass | 481.17500423 g/mol |
| Topological Polar Surface Area | 119 Ų |
| Heavy Atom Count | 36 |
| Formal Charge | 0 |
| Complexity | 778 |
| 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 |
Used as an adjunct to the standard therapy of inhaled steroids with inhaled long- and/or short-acting beta-agonists.
Pranlukast is a cysteinyl leukotriene receptor-1 antagonist.
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.)
R - Respiratory system
R03 - Drugs for obstructive airway diseases
R03D - Other systemic drugs for obstructive airway diseases
R03DC - Leukotriene receptor antagonists
R03DC02 - Pranlukast
Hepatic
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.
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
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 :
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2020-11-13
Registration Number : 20160108-171-I-474-06(1)
Manufacturer Name : Zhejiang Hengkang Pharmaceutical Co., Ltd.
Manufacturer Address : No.1 Longxiang Road, Hairun Street, Sanmen, Zhejiang, China
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
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 :
Registrant Name : Bansen Co., Ltd.
Registration Date : 2016-01-08
Registration Number : 20160108-171-I-474-06
Manufacturer Name : Zhejiang Hengkang Pharmaceutical Co., Ltd.
Manufacturer Address : No.1 Longxiang Road, Hairun Street, Sanmen, Zhejiang, China
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 :
Registrant Name : Kyungbo Pharmaceutical Co., Ltd.
Registration Date : 2011-06-15
Registration Number : 20110615-171-I-12-03
Manufacturer Name : Kyungbo Pharmaceutical Co., Ltd.
Manufacturer Address : 174 Silok-ro, Asan-si, Chungcheongnam-do

Registration Number : 228MF10119
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2016-06-24
Latest Date of Registration :
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2025-10-31
Registration Number : 20251031-171-I-736-11
Manufacturer Name : Zhejiang Ausun Pharmaceutical Co., Ltd.
Manufacturer Address : No.5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China


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

Registration Number : 230MF10049
Registrant's Address : Ramky Pharma City (SEZ), Plot Nos. 96,97,98,124&126,Parawada-531 019,Visakhapatnam District,A. P. , India
Initial Date of Registration : 2018-03-30
Latest Date of Registration :

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 :
Registrant Name : Polaris AI Pharma Co., Ltd.
Registration Date : 2012-08-30
Registration Number : 20120830-171-I-152-02
Manufacturer Name : Polaris AI Pharma Co., Ltd.
Manufacturer Address : Nos. 10 and 11, Block 34, Balan Industrial Complex, 25, Balan Gongdan-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do

Registration Number : 302MF10035
Registrant's Address : Visakha Pharmacity Limited (SEZ), Plot Nos. 96,97,98,124&126, Parawada-531 019, Anakapalli District, A. P. , India
Initial Date of Registration : 2020-03-16
Latest Date of Registration :

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 :
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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
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 Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
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
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

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

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

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

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

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

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

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
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 Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
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
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

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

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

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...

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

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

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

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

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...

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 ...

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...

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...

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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

Lead Product(s) : Pranlukast Hydrate,R713R
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Bioequivalence Study of AJU-R713 and R713R in Healthy Adult Volunteers
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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Lead Product(s) : PRIC,Pranlukast Hydrate
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety, Pharmacokinetic Study of PRIC in Healthy Adult Subjects
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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Lead Product(s) : Pranlukast Hydrate,Inapplicable
Therapeutic Area : Otolaryngology (Ear, Nose, Throat)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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...
4-(4-Phenyl butoxy) benzoic acid
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...
N-(3-Acetyl-2-Hydroxyphenyl)-4-(4-Phenylbutoxy) Be...
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...
3-Amino 2-Hydroxy Acetophenone
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...
1H-Tetrazole-5-carboxylic Acid Ethyl Ester
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...
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...
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...

4-(4-Phenylbutoxy)benzoic acid
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...

3'-[4-(4-Phenylbutoxy)benzoylamino]-2'-hydroxyacet...
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...

8-AMINO-2-(2H-TETRAZOL-5-YL)-4H-CHROMEN-4-ONE HYDR...
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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Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Dry Syrup
Dosage Strength : 10%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Dry Syrup
Dosage Strength : 10%
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India

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Packaging :
Regulatory Info :
Dosage : Dry Syrup
Dosage Strength : 10%
Brand Name :
Approval Date :
Application Number :
Registration Country : India

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Global Sales Information
Market Place
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A Ultair manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ultair, including repackagers and relabelers. The FDA regulates Ultair manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ultair 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 Ultair manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ultair supplier is an individual or a company that provides Ultair active pharmaceutical ingredient (API) or Ultair finished formulations upon request. The Ultair suppliers may include Ultair API manufacturers, exporters, distributors and traders.
click here to find a list of Ultair suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
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 Ultair Drug Master File in Japan (Ultair JDMF) empowers Ultair 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 Ultair JDMF during the approval evaluation for pharmaceutical products. At the time of Ultair 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 Ultair suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ultair Drug Master File in Korea (Ultair KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ultair. The MFDS reviews the Ultair KDMF as part of the drug registration process and uses the information provided in the Ultair KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ultair 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 Ultair API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ultair suppliers with KDMF on PharmaCompass.
Ultair 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 Ultair GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ultair GMP manufacturer or Ultair GMP API supplier for your needs.
A Ultair CoA (Certificate of Analysis) is a formal document that attests to Ultair's compliance with Ultair specifications and serves as a tool for batch-level quality control.
Ultair CoA mostly includes findings from lab analyses of a specific batch. For each Ultair 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.
Ultair may be tested according to a variety of international standards, such as European Pharmacopoeia (Ultair EP), Ultair JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ultair USP).