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1. 4-(((2-amino-3,5-dibromophenyl)methyl)amino)cyclohexanol
2. Abrohexal
3. Am, Bisolvon
4. Ambril
5. Ambro Puren
6. Ambro-puren
7. Ambrobeta
8. Ambrofur
9. Ambrohexal
10. Ambrols
11. Ambrolitic
12. Ambropp
13. Ambropuren
14. Ambroten
15. Ambroxin
16. Ambroxocompren
17. Ambroxol
18. Bisolvon Am
19. Bromhexine Metabolite Viii
20. Bronchopront
21. Bronchowern
22. Broxol
23. Contac Husten Trunk
24. Contac Husten-trunk
25. Contac Hustentrunk
26. Dinobroxol
27. Duramucal
28. Ebromin
29. Expeflen
30. Expit
31. Farmabroxol
32. Flavamed
33. Frenopect
34. Gelopol
35. Hustenlser, Pect
36. Hustenlser, Therapin
37. Larylin Husten Lser
38. Larylin Husten-lser
39. Larylin Hustenlser
40. Lasolvan
41. Metabolite Viii, Bromhexine
42. Mibrox
43. Motosol
44. Muco Fips
45. Muco-fips
46. Mucofips
47. Mucosolvan
48. Mucotablin
49. Na 872
50. Na-872
51. Na872
52. Pdiamuc
53. Pect Hustenlser
54. Pulmonal S
55. Pulmonal, Ringelheimer
56. Ringelheimer Pulmonal
57. Sekretovit
58. Stas Hustenlser
59. Stas-hustenlser
60. Stashustenlser
61. Surbronc
62. Therapin Hustenlser
1. 23828-92-4
2. Ambroxol Hcl
3. Mucoangin
4. Mucosolvan
5. Ambroxolhydrochloride
6. 1384955-66-1
7. 1146648-86-3
8. Lasolvan
9. 15942-05-9
10. Trans-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol Hydrochloride
11. Ambroxol Impurity D Hcl
12. 4-((2-amino-3,5-dibromobenzyl)amino)cyclohexan-1-ol Hydrochloride
13. Cis-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol Hydrochloride
14. Ambroxol Hydrochloride [jan]
15. Ambroxol Hydrochloride
16. Ambroxol (hydrochloride)
17. Ambroxol Hydrochloride, Cis-
18. 4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol;hydrochloride
19. Cc995zmv90
20. R3593uz7hs
21. Ambroxol Impurity D Hydrochloride
22. Na-872
23. Mfcd00078932
24. Nsc-758224
25. Ambroxol Hydrochloride (jan)
26. Ambroxol Hydrochloride 100 Microg/ml In Acetonitrile
27. Mucolear
28. Ambroxol Lozenge
29. Cis-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride
30. Cyclohexanol, 4-(((2-amino-3,5-dibromophenyl)methyl)amino)-, Hydrochloride (1:1), Cis-
31. Smr000875269
32. Na 872 Hydrochloride
33. Ncgc00016781-04
34. Cas-23828-92-4
35. Unii-cc995zmv90
36. Lazolvan
37. Ponophen
38. 4-(2-amino-3,5-dibromobenzylamino)cyclohexanol Hydrochloride
39. Ccris 8686
40. Mucosolvan-l
41. Sr-05000001463
42. Mucosal-l
43. Trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride
44. Hustless (tn)
45. Prestwick_717
46. Einecs 245-899-2
47. Dsstox_cid_25442
48. Dsstox_rid_80883
49. Unii-r3593uz7hs
50. Dsstox_gsid_45442
51. Schembl99455
52. Ambroxol Hydrochloride ,(s)
53. Ambroxol Hydrochloride, 98%
54. Mls001333105
55. Mls001333106
56. Mls002153788
57. Spectrum1503080
58. (e)-4-hdmb
59. Na-872et
60. Chembl1514634
61. Dtxsid2045442
62. Chebi:31198
63. Hy-b1039a
64. Dtxsid60936098
65. Exr-202
66. Hms1569i13
67. Hms1922c19
68. Pharmakon1600-01503080
69. Ambroxol Hydrochloride [mi]
70. 4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol Hydrochloride
71. Bcp04490
72. Tox21_110607
73. Ac-024
74. Ccg-39174
75. Nsc758224
76. S3064
77. (1r,4r)-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol Hydrochloride
78. Akos015895175
79. Akos015951294
80. Akos024462505
81. Ambroxol Hydrochloride [mart.]
82. Ambroxol Hydrochloride [who-dd]
83. Bcp9000284
84. Ccg-220366
85. Ks-5248
86. Nsc 758224
87. Ncgc00016781-03
88. Ncgc00092387-01
89. Ncgc00094999-01
90. Ncgc00094999-02
91. Ba166015
92. Sy052506
93. Ambroxol Hydrochloride, Analytical Standard
94. Bcp0726000073
95. Ambroxol Hydrochloride [ep Impurity]
96. Ambroxol Hydrochloride [ep Monograph]
97. B2267
98. Cs-0013219
99. Ft-0630506
100. Sw198832-2
101. A16398
102. D01479
103. H11915
104. A816928
105. Sr-01000837516
106. Q-100980
107. Sr-01000837516-3
108. Sr-05000001463-2
109. Q27275396
110. Ambroxol Hydrochloride Pound Ep2001/cp2000 Pound(c)
111. F1131-0002
112. Ambroxol Hydrochloride 1.0 Mg/ml In Methanol (as Free Base)
113. Trans-4-(2-amino-3,5-dibromobenzylamino)cyclohexanol Hydrochloride
114. (1r,4r)-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexan-1-ol Hydrochloride
115. (1r,4r)-4-(2-amino-3,5-dibromobenzylamino)cyclohexanol Hydrochloride
116. 4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride, Aldrichcpr
117. Ambroxol Hydrochloride, European Pharmacopoeia (ep) Reference Standard
118. Cyclohexanol, 4-((2-amino-3,5-dibromobenzyl)amino)-, Hydrochloride, Trans-
119. Cyclohexanol, 4-(n-(2-amino-3,5-dibromobenzyl)amino)-, Hydrochloride (e)-
120. Cyclohexanol, 4-[[(2-amino-3,5-dibromophenyl)methyl]amino]-, Hydrochloride
121. Cyclohexanol,4-[[(2-amino-3,5-dibromophenyl)methyl]amino]-,hydrochloride
122. Trans-4-((2-amino-3,5-dibromobenzyl)-amino)cyclohexanol Hydrochloride
123. 4-{[(2-amino-3,5-dibromophenyl)methyl]amino}cyclohexan-1-ol--hydrogen Chloride (1/1)
124. Cyclohexanol, 4-(((2-amino-3,5-dibromophenyl)methyl)amino)-, Monohydrochloride, Trans-
125. Cyclohexanol, 4-[[(2-amino-3,5-dibromophenyl)methyl]amino]-, Hydrochloride (1:1), Trans-
126. Imp. D (ep): Cis-4-[(2-amino-3,5-dibromobenzyl)amino]-cyclohexanol Hcl
127. Trans-4-(((2-amino-3,5-dibromophenyl)methyl)amino)cyclohexan-1-ol Hydrochloride
128. Trans-4-[[(2-amino-3,5-dibromo-phenyl)methyl]amino]-cyclohexanol Hydrochloride
129. Trans-4-[[(2-amino-3,5-dibromophenyl)methyl]amino]cyclohexanol Hydrochloride
| Molecular Weight | 414.56 g/mol |
|---|---|
| Molecular Formula | C13H19Br2ClN2O |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 3 |
| Rotatable Bond Count | 3 |
| Exact Mass | 413.95322 g/mol |
| Monoisotopic Mass | 411.95527 g/mol |
| Topological Polar Surface Area | 58.3 Ų |
| Heavy Atom Count | 19 |
| Formal Charge | 0 |
| Complexity | 259 |
| 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 | 2 |
Expectorants
Agents that increase mucous excretion. Mucolytic agents, that is drugs that liquefy mucous secretions, are also included here. (See all compounds classified as Expectorants.)
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Certificate Number : CEP 2014-135 - Rev 03
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 1489
Status : Valid
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-10-28
Registration Number : 20221028-45-B-470-06
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India
| Available Reg Filing : CN, MX |
Chynops Pharma is an ideal sourcing partner for high-quality APIs, advanced intermediates, speciality chemicals & excipients.
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Certificate Number : CEP 2023-168 - Rev 01
Issue Date : 2025-04-28
Type : Chemical
Substance Number : 1489
Status : Valid
Registration Number : 305MF10118
Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Vadodara-390 020, Gujarat, India
Initial Date of Registration : 2023-11-01
Latest Date of Registration :
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm :
Registrant Name : Hanmi Pharmaceutical Co., Ltd.
Registration Date : 2023-02-27
Registration Number : 20221028-45-B-470-06(1)
Manufacturer Name : Ami Lifesciences Private Limited
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Dist : Vadodara, Gujarat State India
| Available Reg Filing : CN, MX |
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USDMF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40785
Submission : 2024-11-11
Status : Active
Type : II
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Website
Corporate PDF
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Ambroxol Hydrochloride, Process II
Certificate Number : CEP 2023-168 - Rev 01
Status : Valid
Issue Date : 2025-04-28
Type : Chemical
Substance Number : 1489
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Certificate Number : CEP 2014-135 - Rev 03
Status : Valid
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 1489
Certificate Number : CEP 2018-033 - Rev 02
Status : Valid
Issue Date : 2024-11-20
Type : Chemical
Substance Number : 1489
Certificate Number : R1-CEP 2002-142 - Rev 03
Status : Valid
Issue Date : 2011-02-10
Type : Chemical
Substance Number : 1489
Certificate Number : R1-CEP 2004-012 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2011-03-07
Type : Chemical
Substance Number : 1489
Certificate Number : R1-CEP 2002-117 - Rev 02
Status : Valid
Issue Date : 2020-07-10
Type : Chemical
Substance Number : 1489
Certificate Number : R0-CEP 2013-115 - Rev 01
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2016-07-29
Type : Chemical
Substance Number : 1489
Certificate Number : R0-CEP 2004-164 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2006-12-19
Type : Chemical
Substance Number : 1489
Certificate Number : R0-CEP 2015-012 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2017-02-02
Type : Chemical
Substance Number : 1489
Certificate Number : CEP 2023-081 - Rev 00
Status : Valid
Issue Date : 2024-12-02
Type : Chemical
Substance Number : 1489
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Registration Number : 305MF10118
Registrant's Address : 2nd Floor, Prestige Plaza-40, Urmi Society, Near Urmi Cross Road, BPC Road, Akota, Va...
Initial Date of Registration : 2023-11-01
Latest Date of Registration : 2023-11-01
Registration Number : 231MF10088
Registrant's Address : “ADWAVE TOWERS” C/4, THIRD FLOOR NEW NO. 17 (OLD NO.9), SOUTH BOAG ROAD, T. NAGAR...
Initial Date of Registration : 2019-04-11
Latest Date of Registration : 2019-04-11
Registration Number : 228MF10205
Registrant's Address : “ADWAVE TOWERS” C/4, THIRD FLOOR NEW NO. 17 (OLD NO.9), SOUTH BOAG ROAD, T. NAGAR...
Initial Date of Registration : 2016-11-02
Latest Date of Registration : 2016-11-02
Registration Number : 220MF10085
Registrant's Address : S. S. 11 Padana Superiore,N. 8 24040 Fornovo San Giovanni
Initial Date of Registration : 2008-03-18
Latest Date of Registration : 2008-03-18
Registration Number : 221MF10158
Registrant's Address : Via Curiel 34, 20067 Paulo, Milano, ITALY
Initial Date of Registration : 2009-07-21
Latest Date of Registration : 2016-03-02
Ambroxol Hydrochloride (for manufacturing purposes only)
Registration Number : 230MF10131
Registrant's Address : Quattro Muromachi Building 9F, 4-1-6 Muromachi, Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2018-09-06
Latest Date of Registration : 2018-09-06
Registration Number : 222MF10147
Registrant's Address : 6-8, 24, Namdaemun-ro 9-gil, Jung-gu, Seoul, Republic of Korea
Initial Date of Registration : 2010-04-28
Latest Date of Registration : 2019-09-26
Ambroxol Hydrochloride (for manufacturing purposes only)
Registration Number : 219MF10010
Registrant's Address : VIA F. BARACCA 19-24060 SAN PAOLO D'ARGON (BERGAMO) ITALY
Initial Date of Registration : 2007-01-18
Latest Date of Registration : 2008-02-08
Ambroxol hydrochloride (for manufacturing purposes only)
Registration Number : 217MF10603
Registrant's Address : 129 Suidocho, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2009-10-19
Registration Number : 304MF10124
Registrant's Address : Shilpa House, #12-6-214/A1, Hyderabad Road, Raichur-584135, Karnataka, India
Initial Date of Registration : 2022-08-24
Latest Date of Registration : 2022-08-24
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Ambroxol Hydrochloride Ph. Eur
Date of Issue : 2025-08-05
Valid Till : 2028-06-25
Written Confirmation Number : WC-0054
Address of the Firm : Block No. 82/B, ECP Road, At & Post Karakhadi, Tal - Padra, Dist. Baroda, Gujara...
Ambroxol Hydrochloride BP/Ph.Eur.
Date of Issue : 2025-09-19
Valid Till : 2028-09-18
Written Confirmation Number : WC-0348
Address of the Firm : No. A-14, SIDCO Pharmaceutical Complex, Alathur -603110, Thirupporur, Kancheepur...
Date of Issue : 2023-04-18
Valid Till : 2026-01-03
Written Confirmation Number : WC-0086
Address of the Firm : E-17/3, 17/4 & E18 Boisar, MIDCTarapur, Tal.District-Palghar, 401506, Maharashtr...
Date of Issue : 2025-10-09
Valid Till : 2028-07-02
Written Confirmation Number : WC-0148
Address of the Firm : 1A & 1A \'P\', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B, Deosugur Industrial Are...
Ambroxol Hydrochloride BP/IP/EP
Date of Issue : 2023-03-21
Valid Till : 2026-03-20
Written Confirmation Number : WC-0552
Address of the Firm : Plot No. D-2/CH/41A, GIDC Industrial Estate, Dahej Il, Bharuch-392140, Gujarat, ...
Ambroxol Hydrochloride IP/BP/Ph. Eur
Date of Issue : 2025-06-13
Valid Till : 2028-07-02
Written Confirmation Number : WC-0209
Address of the Firm : Plot No. 2903, 05, 07, 09, 10, 2704 to 2708, GIDC Industrial Estate, Village -Sa...
Ambroxol Hydrochloride BP/Ph. Eur.
Date of Issue : 2023-11-09
Valid Till : 2025-10-17
Written Confirmation Number : WC-0388
Address of the Firm : Plot No. 64, Phase 1, Sompura Industrial Area, Dobbespet, Bangalore Rural 562111...
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Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-10-28
Registration Number : 20221028-45-B-470-06
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
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Registrant Name : Hanmi Pharmaceutical Co., Ltd.
Registration Date : 2023-02-27
Registration Number : 20221028-45-B-470-06(1)
Manufacturer Name : Ami Lifesciences Private Lim...
Manufacturer Address : Block No. 82/B, ECP Road At & Post. Karakhadi, Tal-Padra, City : Karakhadi-391450, Di...
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2014-10-20
Registration Number : 20050831-45-B-116-03(1)
Manufacturer Name : Hwail Pharmaceutical Co., Lt...
Manufacturer Address : 57, 3rd Jakyak Industrial Complex Road, Hyangnam-eup, Hwaseong-si, Gyeonggi-do_x000D_
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2005-08-31
Registration Number : 20050831-45-B-112-01
Manufacturer Name : PEN TSAO CHEMICAL INDUSTRY L...
Manufacturer Address : 2 Tie Li Road, Wu Song, shanghai 200940, China
Registrant Name : Opella Healthcare Korea Co., Ltd.
Registration Date : 2020-04-01
Registration Number : 20050915-45-B-206-05(7)
Manufacturer Name : Shilpa Medicare Limited
Manufacturer Address : 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosug...
Registrant Name : Daeshin Pharmaceutical Co., Ltd.
Registration Date : 2011-08-05
Registration Number : 20050915-45-B-206-05(2)
Manufacturer Name : Shilpa Pharma Lifesciences L...
Manufacturer Address : 1A & 1A'P', 1B, 2, 2A, 2B, 3A to 3E, 4A, 5A, 4B & 5B Deosugur Industrial Area, Deosug...
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Registration Date : 2020-03-25
Registration Number : 20050915-45-B-206-05(6)
Manufacturer Name : Shilpa Pharma Lifesciences L...
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Registration Date : 2021-04-23
Registration Number : 20050915-45-B-206-05(8)
Manufacturer Name : Shilpa Pharma Lifesciences L...
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Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2005-09-15
Registration Number : 20050915-45-B-206-05
Manufacturer Name : Shilpa Pharma Lifesciences L...
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Registration Date : 2016-07-29
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NDC Package Code : 12828-0093
Start Marketing Date : 2022-08-04
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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PharmaCompass offers a list of Ambroxol Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ambroxol Hydrochloride manufacturer or Ambroxol Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ambroxol Hydrochloride manufacturer or Ambroxol Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ambroxol Hydrochloride API Price utilized in the formulation of products. Ambroxol Hydrochloride API Price is not always fixed or binding as the Ambroxol Hydrochloride Price is obtained through a variety of data sources. The Ambroxol Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ambroxol Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ambroxol Hydrochloride, including repackagers and relabelers. The FDA regulates Ambroxol Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ambroxol Hydrochloride 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 Ambroxol Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ambroxol Hydrochloride supplier is an individual or a company that provides Ambroxol Hydrochloride active pharmaceutical ingredient (API) or Ambroxol Hydrochloride finished formulations upon request. The Ambroxol Hydrochloride suppliers may include Ambroxol Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Ambroxol Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ambroxol Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Ambroxol Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Ambroxol Hydrochloride DMFs exist exist since differing nations have different regulations, such as Ambroxol Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ambroxol Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Ambroxol Hydrochloride USDMF includes data on Ambroxol Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ambroxol Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ambroxol Hydrochloride suppliers with USDMF 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 Ambroxol Hydrochloride Drug Master File in Japan (Ambroxol Hydrochloride JDMF) empowers Ambroxol Hydrochloride 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 Ambroxol Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Ambroxol Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ambroxol Hydrochloride Drug Master File in Korea (Ambroxol Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ambroxol Hydrochloride. The MFDS reviews the Ambroxol Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Ambroxol Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ambroxol Hydrochloride 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 Ambroxol Hydrochloride API can apply through the Korea Drug Master File (KDMF).
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A Ambroxol Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Ambroxol Hydrochloride Certificate of Suitability (COS). The purpose of a Ambroxol Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ambroxol Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ambroxol Hydrochloride to their clients by showing that a Ambroxol Hydrochloride CEP has been issued for it. The manufacturer submits a Ambroxol Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ambroxol Hydrochloride CEP holder for the record. Additionally, the data presented in the Ambroxol Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ambroxol Hydrochloride DMF.
A Ambroxol Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ambroxol Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Ambroxol Hydrochloride written confirmation (Ambroxol Hydrochloride WC) is an official document issued by a regulatory agency to a Ambroxol Hydrochloride manufacturer, verifying that the manufacturing facility of a Ambroxol Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ambroxol Hydrochloride APIs or Ambroxol Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Ambroxol Hydrochloride WC (written confirmation) as part of the regulatory process.
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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 Ambroxol Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ambroxol Hydrochloride API and other APIs are published in this directory by the FDA.
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 Ambroxol Hydrochloride 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.
The NDC directory also contains data on finished compounded human drug products that contain Ambroxol Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ambroxol Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ambroxol Hydrochloride suppliers with NDC on PharmaCompass.
Ambroxol Hydrochloride 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 Ambroxol Hydrochloride 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 Ambroxol Hydrochloride GMP manufacturer or Ambroxol Hydrochloride GMP API supplier for your needs.
A Ambroxol Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Ambroxol Hydrochloride's compliance with Ambroxol Hydrochloride specifications and serves as a tool for batch-level quality control.
Ambroxol Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Ambroxol Hydrochloride 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.
Ambroxol Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Ambroxol Hydrochloride EP), Ambroxol Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ambroxol Hydrochloride USP).
