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Chemistry

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Also known as: 52-89-1, L-cysteine.hcl, L-cysteine hydrochloride anhydrous, L-cysteine, hydrochloride, L-cysteine hcl anhydrous, (r)-cysteine hydrochloride
Molecular Formula
C3H8ClNO2S
Molecular Weight
157.62  g/mol
InChI Key
IFQSXNOEEPCSLW-DKWTVANSSA-N
FDA UNII
A9U1687S1S

L-Cysteine Hydrochloride
A thiol-containing non-essential amino acid that is oxidized to form CYSTINE.
1 2D Structure

L-Cysteine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2R)-2-amino-3-sulfanylpropanoic acid;hydrochloride
2.1.2 InChI
InChI=1S/C3H7NO2S.ClH/c4-2(1-7)3(5)6;/h2,7H,1,4H2,(H,5,6);1H/t2-;/m0./s1
2.1.3 InChI Key
IFQSXNOEEPCSLW-DKWTVANSSA-N
2.1.4 Canonical SMILES
C(C(C(=O)O)N)S.Cl
2.1.5 Isomeric SMILES
C([C@@H](C(=O)O)N)S.Cl
2.2 Other Identifiers
2.2.1 UNII
A9U1687S1S
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Cysteine

2. Cysteine Hydrochloride

3. Half Cystine

4. Half-cystine

5. L Cysteine

6. L-cysteine

7. Zinc Cysteinate

2.3.2 Depositor-Supplied Synonyms

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%

2.4 Create Date
2005-07-19
3 Chemical and Physical Properties
Molecular Weight 157.62 g/mol
Molecular Formula C3H8ClNO2S
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count4
Rotatable Bond Count2
Exact Mass156.9964274 g/mol
Monoisotopic Mass156.9964274 g/mol
Topological Polar Surface Area64.3 Ų
Heavy Atom Count8
Formal Charge0
Complexity75.3
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API SUPPLIERS

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Axplora

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Taenaka Kogyo

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Taenaka Kogyo

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Nippon Protein Co Ltd

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Ajinomoto Company

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USDMF

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Tanabe Seiyaku Co Ltd

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 1930

Submission : 1972-05-09

Status : Inactive

Type : II

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Nippon Protein Co Ltd

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DMF Review : Complete

Rev. Date : 2018-08-14

Pay. Date : 2018-07-02

DMF Number : 21364

Submission : 2008-02-26

Status : Active

Type : II

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Taenaka Kogyo Co Ltd

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DMF Review : Complete

Rev. Date : 2017-10-27

Pay. Date : 2017-03-14

DMF Number : 8866

Submission : 1990-11-30

Status : Active

Type : II

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R1-CEP 1997-014 - Rev 03
Valid
Chemical
2014-04-24
895
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Certificate Number : R1-CEP 1997-014 - Rev 03

Status : Valid

Issue Date : 2014-04-24

Type : Chemical

Substance Number : 895

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JDMF

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Japanese Pharmacopoeia L-Ethylcysteine ​​Hydrochloride

Registration Number : 219MF10005

Registrant's Address : 4-2-2 Nihonbashi Honcho, Chuo Ward, Tokyo

Initial Date of Registration : 2007-01-18

Latest Date of Registration : 2007-01-18

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L-Cysteine ​​hydrochloride (monohydrate) (Nippon Pro)

Registration Number : 217MF10553

Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture

Initial Date of Registration : 2005-09-09

Latest Date of Registration : 2007-08-07

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Japanese Pharmacopoeia L-Cysteine ​​Hydrochloride Hydrate "For manufacturing only"

Registration Number : 220MF10016

Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture

Initial Date of Registration : 2008-01-09

Latest Date of Registration : 2008-01-09

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Japanese Pharmacopoeia L-Cysteine ​​Hydrochloride Hydrate (for manufacturing only)

Registration Number : 220MF10229

Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture

Initial Date of Registration : 2008-11-17

Latest Date of Registration : 2008-11-17

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L-Cysteine HCl Monohydrate Ph. Eur

Date of Issue : 2022-06-24

Valid Till : 2025-07-02

Written Confirmation Number : WC-0102

Address of the Firm : Plot No.B5 & B6, A1&A2, MEPZ- Tambaram, Chennai-600045

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NDC API

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CYSTEINE HYDROCHLORIDE

NDC Package Code : 17333-909

Start Marketing Date : 2008-06-30

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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CYSTEINE HYDROCHLORIDE

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 P...

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CYSTEINE HYDROCHLORIDE

NDC Package Code : 53884-1013

Start Marketing Date : 2023-01-27

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT FOR HUMAN P...

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CYSTEINE HYDROCHLORIDE

NDC Package Code : 10695-128

Start Marketing Date : 2024-06-03

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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L-Cysteine Hydrochloride

About the Company : Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-qual...

Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.
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Medlab Asia & Asia Health
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L-Cysteine HCl

About the Company : The Ajinomoto Group Standards of Business Conduct (hereinafter the "Standards of Conduct") describe the conduct that every member of the Ajinomoto Group must understand and practic...

The Ajinomoto Group Standards of Business Conduct (hereinafter the "Standards of Conduct") describe the conduct that every member of the Ajinomoto Group must understand and practice every day in order to implement the Ajinomoto Group Philosophy in accordance with the Ajinomoto Group Way. The Standards of Conduct also represent the commitments made to all stakeholders by Ajinomoto Group companies. We conduct ourselves in a socially responsible manner based on the values and ethics set forth under the Ajinomoto Group Philosophy: "We create better lives globally by contributing to significant advances in Food and Health and working for Life."
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Medlab Asia & Asia Health
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L-Cysteine Hydrochloride Monohydrate

About the Company : Apotex Pharmachem is a global fully integrated API R&D and manufacturing organization with its headquarters located in Brantford, Ontario, Canada and is a member of the Apotex grou...

Apotex Pharmachem is a global fully integrated API R&D and manufacturing organization with its headquarters located in Brantford, Ontario, Canada and is a member of the Apotex group of companies. Currently employing more than 1600 highly-skilled and motivated professionals globally, Apotex Pharmachem has multiple facilities around the world located in Canada, India, Mexico, and China.
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Medlab Asia & Asia Health
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L-Cysteine Hydrochloride Monohydrate

About the Company : We specialize in the supply of API and API related intermediates and services. A significant part of our business comes from the process/production development tailored to our cust...

We specialize in the supply of API and API related intermediates and services. A significant part of our business comes from the process/production development tailored to our customers' requirement.We see our core-value in our top-of-the-rank R&D capabilities, strict quality system, fast communication with accuracy and 15years of continued dedication to pharmaceutical and chemical industries.We take pride in the long term partnership with our reputed customers, and feel truly fortunate to work with mutual and respect. We constantly strive to keep up with their ever increasing expectation, to ensure we are worthy of their trust and reliance.
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API Reference Price

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XIHU DISTRICT HANGZHOU, SDNF CHINA","customerAddress":"PLOT.NO.49,CANARA BANK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730053800,"product":"L-CYSTEINE HYDROCHLORIDE MONOHYDRATE L-CYSTEINE HYDROCHLORIDE MONOHYDRATE","address":"B-5 AND B6 MEPZ","city":"CHENNAI","supplier":"NANJING JOYIN PHARMACHEM CO, LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"PHARMAZELL","customerCountry":"INDIA","quantity":"23400.00","actualQuantity":"23400","unit":"KGS","unitRateFc":"8.3","totalValueFC":"195171.6","currency":"USD","unitRateINR":"700.8","date":"28-Oct-2024","totalValueINR":"16399597.5","totalValueInUsd":"195171.6","indian_port":"Madras-EPZ\/SEZ","hs_no":"29309040","bill_no":"6377406","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 1201 BUILDING C, WANDA PLAZA NO.108 MIDDLE JIANGDONG ROAD JIANYE DISTRICT, NANJING CHINA","customerAddress":"B-5 AND B6 MEPZ"}]
22-Jan-2021
28-Oct-2024
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Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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Drugs in Development

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Details:

U.S.FDA granted company,180 days of generic exclusivity as a result of being the first ANDA submitted for cysteine hydrochloride injection, a bioequivalent generic of Exela Pharma Sciences’ Elcys, against the reference product.


Lead Product(s): L-Cysteine Hydrochloride

Therapeutic Area: Nutrition and Weight Loss Brand Name: Cysteine Hydrochloride - Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 11, 2022

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01

Medlab Asia & Asia Health
Not Confirmed
Medlab Asia & Asia Health
Not Confirmed

Details : U.S.FDA granted company,180 days of generic exclusivity as a result of being the first ANDA submitted for cysteine hydrochloride injection, a bioequivalent generic of Exela Pharma Sciences’ Elcys, against the reference product.

Brand Name : Cysteine Hydrochloride - Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 11, 2022

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SOLUTION;INTRAVENOUS - 2500MG/50ML (...DOSAGE - SOLUTION;INTRAVENOUS - 2500MG/50ML (50MG/ML)

USFDA APPLICATION NUMBER - 210660

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DOSAGE - SOLUTION;INTRAVENOUS - 500MG/10ML (5...DOSAGE - SOLUTION;INTRAVENOUS - 500MG/10ML (50MG/ML)

USFDA APPLICATION NUMBER - 210660

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APIs

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Patents & EXCLUSIVITIES

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US Patents

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01

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Medlab Asia & Asia Health
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Medlab Asia & Asia Health
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CYSTEINE HYDROCHLORIDE

US Patent Number : 11648262

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212535

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-01-15

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02

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Medlab Asia & Asia Health
Not Confirmed
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Medlab Asia & Asia Health
Not Confirmed

CYSTEINE HYDROCHLORIDE

US Patent Number : 11642370

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212535

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-01-15

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03

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Medlab Asia & Asia Health
Not Confirmed
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Medlab Asia & Asia Health
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CYSTEINE HYDROCHLORIDE

US Patent Number : 10933089

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212535

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-01-15

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04

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Medlab Asia & Asia Health
Not Confirmed
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Medlab Asia & Asia Health
Not Confirmed

CYSTEINE HYDROCHLORIDE

US Patent Number : 10493051

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212535

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-03-15

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05

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Medlab Asia & Asia Health
Not Confirmed
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Medlab Asia & Asia Health
Not Confirmed

CYSTEINE HYDROCHLORIDE

US Patent Number : 10543186

Drug Substance Claim :

Drug Product Claim :

Application Number : 212535

Patent Use Code : U-2722

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-03-15

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06

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Medlab Asia & Asia Health
Not Confirmed
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Medlab Asia & Asia Health
Not Confirmed

CYSTEINE HYDROCHLORIDE

US Patent Number : 10905713

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212535

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-01-15

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07

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Medlab Asia & Asia Health
Not Confirmed

EXELA PHARMA

U.S.A
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Medlab Asia & Asia Health
Not Confirmed

CYSTEINE HYDROCHLORIDE

US Patent Number : 10905714

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210660

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-01-15

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08

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Medlab Asia & Asia Health
Not Confirmed

EXELA PHARMA

U.S.A
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Medlab Asia & Asia Health
Not Confirmed

CYSTEINE HYDROCHLORIDE

US Patent Number : 10478453

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210660

Patent Use Code : U-2752

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-01-15

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09

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Medlab Asia & Asia Health
Not Confirmed

EXELA PHARMA

U.S.A
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Medlab Asia & Asia Health
Not Confirmed

CYSTEINE HYDROCHLORIDE

US Patent Number : 10583155

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210660

Patent Use Code : U-2752

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-01-15

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10

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Medlab Asia & Asia Health
Not Confirmed

EXELA PHARMA

U.S.A
arrow
Medlab Asia & Asia Health
Not Confirmed

CYSTEINE HYDROCHLORIDE

US Patent Number : 11648262

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 210660

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-01-15

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