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1. Cysteine
2. Cysteine Hydrochloride
3. Half Cystine
4. Half-cystine
5. L Cysteine
6. L-cysteine
7. Zinc Cysteinate
1. 52-89-1
2. L-cysteine.hcl
3. L-cysteine Hydrochloride Anhydrous
4. L-cysteine, Hydrochloride
5. L-cysteine Hcl Anhydrous
6. (r)-cysteine Hydrochloride
7. (r)-2-amino-3-mercaptopropanoic Acid Hydrochloride
8. L-cysteine Hcl
9. L-(+)-cysteine Hydrochloride
10. Cysteine Hydrochloride
11. Cysteine Monohydrochloride
12. L-cysteine, Hcl
13. L-cysteine Monohydrochloride
14. Cysteine Hcl
15. Cystein Chloride
16. Cysteine Hcl (anhydrous)
17. Cysteine Hydrochloride (anhydrous)
18. Cysteine, L-, Hydrochloride
19. Cysteine Hydrochloride Anhydrous
20. L-cysteine, Hydrochloride (1:1)
21. Cysteine Chlorhydrate
22. L-cysteine (hydrochloride)
23. H-cys-oh.hcl
24. Nsc 8746
25. A9u1687s1s
26. 3-mercaptoalanine Hydrochloride
27. Ek 2367
28. Cysteine (as Hydrochloride)
29. Ccris 3613
30. Cysteine, L-, Monohydrochloride
31. Nsc-755898
32. Einecs 200-157-7
33. Wr 348
34. Cysteine-hcl
35. Unii-a9u1687s1s
36. Ai3-18781
37. L-cysteine Hydrochloride, Anhydrous
38. Mfcd00064553
39. Cysteine-hydrochloride
40. L-cysteinium Chloride
41. H-cys-oh?cl
42. L-cysteine Chlorhydrate
43. Dsstox_cid_367
44. L-cysteine Hydro-chloride
45. L-cysteine Hydrochloride;
46. Ec 200-157-7
47. Dsstox_rid_75543
48. Dsstox_gsid_20367
49. Schembl18161
50. L-cysteinemethyl Hydrochloride
51. L-2-amino-3-mercaptopropanoic Acid Monohydrochloride
52. Chembl1200630
53. Dtxsid0020367
54. Chebi:91247
55. Hy-y0337a
56. Tox21_200699
57. S4815
58. Akos015849225
59. Ccg-266272
60. Cs-w018517
61. Cysteine Hydrochloride [who-dd]
62. Cas-52-89-1
63. Cysteine Hydrochloride, Anhydrous
64. (r)-(+)-cysteine Hydrochloride Hydrate
65. Ncgc00258253-01
66. (2r)-2-amino-3-mercapto-propionic Acid
67. Ac-12796
68. As-11682
69. L-cysteine Hydrochloride [usp-rs]
70. L-cysteine Hydrochloride, 98.0-102.0%
71. Cysteine Hydrochloride Anhydrous [ii]
72. Cysteine Hydrochloride Anhydrous [mi]
73. (r)2-amino-3-thiopropanoic Acid Hydrochloride
74. E72644
75. (r)-2-amino-3-mercaptopropanoicacidhydrochloride
76. 064c553
77. A829298
78. (1r)-1-carboxy-2-sulfanylethan-1-aminium Chloride
79. (2r)-2-amino-3-sulfanylpropanoic Acid;hydrochloride
80. J-019666
81. L-cysteine Hydrochloride, Anhydrous, >=98% (tlc)
82. W-105789
83. L-cysteine Hydrochloride, Anhydrous, >=99.0% (rt)
84. Q27163158
85. L-cysteine Hydrochloride, Fg, Product Of Wacker Chemie Ag
86. L-cysteine Hydrochloride, Vetec(tm) Reagent Grade, >=98%
87. (2r)-2-amino-3-sulfanyl-propanoic Acid Hydrochloride;h-cys-oh.hcl
88. L-cysteine Hydrochloride, Anhydrous, From Non-animal Source, Bioreagent, Suitable For Cell Culture, >=98.0%
| Molecular Weight | 157.62 g/mol |
|---|---|
| Molecular Formula | C3H8ClNO2S |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 4 |
| Rotatable Bond Count | 2 |
| Exact Mass | 156.9964274 g/mol |
| Monoisotopic Mass | 156.9964274 g/mol |
| Topological Polar Surface Area | 64.3 Ų |
| Heavy Atom Count | 8 |
| Formal Charge | 0 |
| Complexity | 75.3 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
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Certificate Number : R1-CEP 1997-014 - Rev 03
Issue Date : 2014-04-24
Type : Chemical
Substance Number : 895
Status : Valid
| Available Reg Filing : EU |
Date of Issue : 2022-06-24
Valid Till : 2025-07-02
Written Confirmation Number : WC-0102n
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-27
Pay. Date : 2017-03-14
DMF Number : 8866
Submission : 1990-11-30
Status : Active
Type : II
Registration Number : 220MF10229
Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture
Initial Date of Registration : 2008-11-17
Latest Date of Registration :
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-08-14
Pay. Date : 2018-07-02
DMF Number : 21364
Submission : 2008-02-26
Status : Active
Type : II
Registration Number : 220MF10016
Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture
Initial Date of Registration : 2008-01-09
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1930
Submission : 1972-05-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2753
Submission : 1976-10-15
Status : Inactive
Type : II
NDC Package Code : 12497-1013
Start Marketing Date : 1978-03-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10741
Submission : 1994-02-28
Status : Inactive
Type : II
NDC Package Code : 17333-909
Start Marketing Date : 2008-06-30
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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USDMF
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Cysteine Hydrochloride Monohydrate Ph.Eur
Date of Issue : 2022-06-24
Valid Till : 2025-07-02
Written Confirmation Number : WC-0102n
Address of the Firm : Plot No. B5&B6, A1&A2, MEPZ-Tambaram, Chennai-600 045, India
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DOSAGE - SOLUTION;INTRAVENOUS - 2500MG/50ML (...DOSAGE - SOLUTION;INTRAVENOUS - 2500MG/50ML (50MG/ML)
USFDA APPLICATION NUMBER - 210660
DOSAGE - SOLUTION;INTRAVENOUS - 500MG/10ML (5...DOSAGE - SOLUTION;INTRAVENOUS - 500MG/10ML (50MG/ML)
USFDA APPLICATION NUMBER - 210660
Digital Content
NEWS #PharmaBuzz
29 Nov 2023
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-29-2023-18805.pdf
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/exela-pharma-sciences-llc-issues-voluntary-nationwide-recall-84-sodium-bicarbonate-injection-usp-50
11 Apr 2022
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2022/04/11/2419949/0/en/Eton-Pharmaceuticals-Announces-FDA-Approval-of-Cysteine-Hydrochloride-Injection.html
08 Apr 2022
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214082
07 May 2020
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2020/05/07/2029382/0/en/Eton-Pharmaceuticals-Confirms-First-to-File-Patent-Challenge-on-Elcys-Cysteine-Hydrochloride-Injection.html
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PharmaCompass offers a list of L-Cysteine 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 L-Cysteine Hydrochloride manufacturer or L-Cysteine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred L-Cysteine Hydrochloride manufacturer or L-Cysteine Hydrochloride supplier.
PharmaCompass also assists you with knowing the L-Cysteine Hydrochloride API Price utilized in the formulation of products. L-Cysteine Hydrochloride API Price is not always fixed or binding as the L-Cysteine Hydrochloride Price is obtained through a variety of data sources. The L-Cysteine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cysteine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cysteine Hydrochloride, including repackagers and relabelers. The FDA regulates Cysteine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cysteine 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 Cysteine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cysteine Hydrochloride supplier is an individual or a company that provides Cysteine Hydrochloride active pharmaceutical ingredient (API) or Cysteine Hydrochloride finished formulations upon request. The Cysteine Hydrochloride suppliers may include Cysteine Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Cysteine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cysteine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cysteine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cysteine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Cysteine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cysteine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cysteine Hydrochloride USDMF includes data on Cysteine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cysteine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cysteine 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 Cysteine Hydrochloride Drug Master File in Japan (Cysteine Hydrochloride JDMF) empowers Cysteine 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 Cysteine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Cysteine Hydrochloride 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 Cysteine Hydrochloride suppliers with JDMF on PharmaCompass.
A Cysteine Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Cysteine Hydrochloride Certificate of Suitability (COS). The purpose of a Cysteine Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cysteine Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cysteine Hydrochloride to their clients by showing that a Cysteine Hydrochloride CEP has been issued for it. The manufacturer submits a Cysteine Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cysteine Hydrochloride CEP holder for the record. Additionally, the data presented in the Cysteine Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cysteine Hydrochloride DMF.
A Cysteine Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cysteine Hydrochloride CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Cysteine Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Cysteine Hydrochloride written confirmation (Cysteine Hydrochloride WC) is an official document issued by a regulatory agency to a Cysteine Hydrochloride manufacturer, verifying that the manufacturing facility of a Cysteine Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Cysteine Hydrochloride APIs or Cysteine Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Cysteine Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Cysteine Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
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 Cysteine Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cysteine 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 Cysteine 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 Cysteine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cysteine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cysteine Hydrochloride suppliers with NDC on PharmaCompass.
Cysteine 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 Cysteine 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 Cysteine Hydrochloride GMP manufacturer or Cysteine Hydrochloride GMP API supplier for your needs.
A Cysteine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Cysteine Hydrochloride's compliance with Cysteine Hydrochloride specifications and serves as a tool for batch-level quality control.
Cysteine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Cysteine 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.
Cysteine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cysteine Hydrochloride EP), Cysteine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cysteine Hydrochloride USP).
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