Synopsis
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JDMF
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KDMF
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NDC API
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FDA Orange Book
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Europe
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Canada
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1. Barberry Root
2. Barberry Root Extract
3. Berberidis Radix
4. Berberidis Radix Extract
5. Berberis Wilsoniae Root
6. Berberis Wilsoniae Root Extract
7. Sankezhen
1. Berberine Hydrochloride
2. 633-65-8
3. Natural Yellow 18
4. Berberinium Chloride
5. Benzodioxide
6. Berberine Hcl
7. Berberine (chloride)
8. Berberinum
9. Nsc-163088
10. Berberin Hydrochloride
11. 9,10-dimethoxy-5,6-dihydro-[1,3]dioxolo[4,5-g]isoquinolino[3,2-a]isoquinolin-7-ium Chloride
12. Mfcd00011939
13. Uot4o1byv8
14. Nsc-646666
15. Mls002702530
16. Natural Yellow 18 (chloride)
17. Chebi:31271
18. Nsc163088
19. 633-65-8 (chloride)
20. Dsstox_cid_4602
21. Berbinium, 7,8,13,13a-tetradehydro-9,10-dimethoxy-2,3-(methylenedioxy)-, Chloride
22. 5,6-dihydro-9,10-dimethoxybenzo[g]-1,3-benzodioxolo[5,6-a]quinolizinium Chloride
23. Benzo(g)-1,3-benzodioxolo(5,6-a)quinolizinium, 5,6-dihydro-9,10-dimethoxy-, Chloride
24. Dsstox_rid_77465
25. Dsstox_gsid_24602
26. Berberinium Chloride Hydrate
27. Chembl12089
28. Berberine Chloride [jan]
29. Gnf-pf-4545
30. 16,17-dimethoxy-5,7-dioxa-13$l^{5}-azapentacyclo[11.8.0.0^{2,10}.0^{4,8}.0^{15,20}]henicosa-1(13),2,4(8),9,14,16,18,20-octaen-13-ylium Chloride
31. Smr001233240
32. Nsc646666
33. Berberine Chloride Form
34. Sr-01000711827
35. Ncgc00016526-02
36. Ncgc00016526-07
37. Cas-633-65-8
38. Einecs 211-195-9
39. Unii-uot4o1byv8
40. Nsc 163088
41. Berberine Chloride, Primary Pharmaceutical Reference Standard
42. Ai3-61834
43. Ccris 8656
44. 5,6-dihydro-9,10-dimethoxybenzo(g)-1,3-benzodioxolo(5,6-a)quinolizinium Chloride
45. Prestwick_91
46. Barberry Root Extract
47. Nsc 646666
48. Dimethoxy[?] Chloride
49. Berberine Chloride (tn)
50. Berberinum [hpus]
51. Berberine Hydrochloride,(s)
52. Mls002153890
53. Schembl153906
54. Spectrum1500811
55. Dtxsid8024602
56. Hms500n07
57. Chebi: 16118
58. Hms1569f14
59. Hms1921i18
60. Hms2096f14
61. Hms2210a06
62. Hms2235h16
63. Hms3336c05
64. Hms3373l14
65. Hms3655f20
66. Pharmakon1600-01500811
67. Berberine Chloride [usp-rs]
68. Tox21_110474
69. Tox21_200348
70. Ac-118
71. Ccg-39622
72. Nsc757795
73. S2271
74. Akos007930622
75. Tox21_110474_1
76. Cs-3214
77. Ks-5294
78. Nsc-757795
79. 5,6-dihydro-9,10-dimethoxybenzo(g)-1,3-benzodioxolo(5,6-a)quinolizinium Chloride Hydrate
80. Benzo[g]-1,3-benzodioxolo[5,6-a]quinolizinium,5,6-dihydro-9,10-dimethoxy-, Chloride
81. Berberine Hydrochloride [who-dd]
82. Ncgc00091896-01
83. Ncgc00094858-01
84. Ncgc00094858-02
85. Ncgc00257902-01
86. 16,17-dimethoxy-5,7-dioxa-13-azoniapentacyclo[11.8.0.02,10.04,8.015,20]henicosa-1(13),2,4(8),9,14,16,18,20-octaene;chloride
87. Hy-18258
88. Sy076593
89. Cas: 638-65-8
90. B0450
91. Ft-0622874
92. N1699
93. Sw196403-2
94. A834344
95. Berberine Chloride Hydrate, Technical, >=90% (at)
96. Q-100261
97. Q-100731
98. Sr-01000711827-4
99. Sr-01000711827-6
100. Z2768724441
101. Berberine Chloride, British Pharmacopoeia (bp) Reference Standard
102. Berberine Chloride, European Pharmacopoeia (ep) Reference Standard
103. Benzo[g]-1,6-a]quinolizinium, 5,6-dihydro-9,10-dimethoxy-, Chloride
104. Berberine Chloride, United States Pharmacopeia (usp) Reference Standard
105. 5,6-dihydro-9,10-dimethoxy-1,3-benzodioxolo[5,6-a]benzo[g]quinolizinium Chloride (1:1)
106. Berberine Chloride, Pharmaceutical Secondary Standard; Certified Reference Material
107. Berbinium,8,13,13a-tetradehydro-9.10-dimethoxy-2,3-(methylene Dioxy)-, Chloride
108. 16,17-dimethoxy-5,7-dioxa-13lambda5-azapentacyclo[11.8.0.0^{2,10}.0^{4,8}.0^{15,20}]henicosa-1(21),2(10),3,8,13,15(20),16,18-octaen-13-ylium Chloride
109. 9,10-dimethoxy-5,6-dihydro-[1,3]dioxolo[4,5-g]isoquinolino[3,2-a]isoquinolin-7-iumchloride
110. Benzo(g)-1,3-benzodioxolo(5,6-a)quinolizinium, 5,6-dihydro-9,10-dimethoxy-, Chloride (1:1)
| Molecular Weight | 371.8 g/mol |
|---|---|
| Molecular Formula | C20H18ClNO4 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 2 |
| Exact Mass | 371.0924357 g/mol |
| Monoisotopic Mass | 371.0924357 g/mol |
| Topological Polar Surface Area | 40.8 Ų |
| Heavy Atom Count | 26 |
| Formal Charge | 0 |
| Complexity | 488 |
| 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 |
API SUPPLIERS
Sichuan Elixir Pharmaceutical, a manufacturer of small molecule APIs & a CMO/CDMO service provider for anti-tumor characteristic APIs..
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35391
Submission : 2020-11-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38587
Submission : 2023-07-05
Status : Active
Type : II
Date of Issue : 2022-01-04
Valid Till : 2025-02-01
Written Confirmation Number : WC-0350
Address of the Firm :
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Average Price (USD/KGS) |
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ABOUT THIS PAGE
A Berberine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Berberine Hydrochloride, including repackagers and relabelers. The FDA regulates Berberine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Berberine 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 Berberine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Berberine Hydrochloride supplier is an individual or a company that provides Berberine Hydrochloride active pharmaceutical ingredient (API) or Berberine Hydrochloride finished formulations upon request. The Berberine Hydrochloride suppliers may include Berberine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Berberine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Berberine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Berberine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Berberine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Berberine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Berberine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Berberine Hydrochloride USDMF includes data on Berberine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Berberine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Berberine Hydrochloride suppliers with USDMF on PharmaCompass.
A Berberine Hydrochloride written confirmation (Berberine Hydrochloride WC) is an official document issued by a regulatory agency to a Berberine Hydrochloride manufacturer, verifying that the manufacturing facility of a Berberine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Berberine Hydrochloride APIs or Berberine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Berberine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Berberine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
Berberine 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 Berberine 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 Berberine Hydrochloride GMP manufacturer or Berberine Hydrochloride GMP API supplier for your needs.
A Berberine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Berberine Hydrochloride's compliance with Berberine Hydrochloride specifications and serves as a tool for batch-level quality control.
Berberine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Berberine 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.
Berberine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Berberine Hydrochloride EP), Berberine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Berberine Hydrochloride USP).
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