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Chemistry

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Also known as: 156-57-0, 2-aminoethanethiol hydrochloride, Cysteamine hcl, 2-mercaptoethylamine hydrochloride, Mercaptamine hydrochloride, Bekaptan
Molecular Formula
C2H8ClNS
Molecular Weight
113.61  g/mol
InChI Key
OGMADIBCHLQMIP-UHFFFAOYSA-N
FDA UNII
IF1B771SVB

Cysteamine Hydrochloride
A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS.
1 2D Structure

Cysteamine Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-aminoethanethiol;hydrochloride
2.1.2 InChI
InChI=1S/C2H7NS.ClH/c3-1-2-4;/h4H,1-3H2;1H
2.1.3 InChI Key
OGMADIBCHLQMIP-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C(CS)N.Cl
2.2 Other Identifiers
2.2.1 UNII
IF1B771SVB
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2 Aminoethanethiol

2. 2-aminoethanethiol

3. 35s-labeled Cysteamine

4. Becaptan

5. Beta Mercaptoethylamine

6. Beta-mercaptoethylamine

7. Bitartrate, Cysteamine

8. Cystagon

9. Cysteamine

10. Cysteamine Bitartrate

11. Cysteamine Dihydrochloride

12. Cysteamine Hydrobromide

13. Cysteamine Maleate (1:1)

14. Cysteamine Tartrate

15. Cysteamine Tartrate (1:1)

16. Cysteamine Tosylate

17. Cysteamine, 35s Labeled

18. Cysteamine, 35s-labeled

19. Cysteinamine

20. Dihydrochloride, Cysteamine

21. Hydrobromide, Cysteamine

22. Hydrochloride, Cysteamine

23. Mercamine

24. Mercaptamine

25. Mercaptoethylamine

26. Tartrate, Cysteamine

27. Tosylate, Cysteamine

2.3.2 Depositor-Supplied Synonyms

1. 156-57-0

2. 2-aminoethanethiol Hydrochloride

3. Cysteamine Hcl

4. 2-mercaptoethylamine Hydrochloride

5. Mercaptamine Hydrochloride

6. Bekaptan

7. Cysteaminium Chloride

8. Ethanethiol, 2-amino-, Hydrochloride

9. Mercaptoethylamine Hydrochloride

10. Cysteamine (hydrochloride)

11. 2-thioethylamine Hydrochloride

12. Cysteamine Hydrochloride [usan]

13. 2-aminoethane-1-thiol Hydrochloride

14. 2-aminoethanethiol;hydrochloride

15. Beta-mercaptoethylamine Hydrochloride

16. Mfcd00012904

17. Nsc-758692

18. 2-mercaptoethylammonium Chloride

19. Ci-9148

20. If1b771svb

21. Thioethanolamine Hydrochloride

22. 2-aminoethylmercaptan Hydrochloride

23. Nsc-21116

24. Nsc-25116

25. Ncgc00094090-01

26. 2-mercaptoethylamine Hcl

27. Dsstox_cid_25779

28. Dsstox_rid_81121

29. Dsstox_gsid_45779

30. Merkamin Hydrochloride

31. Cysteamine Hydrochloride (usan)

32. Mercamine Hydrochloride

33. Cysteamine Chlorohydrate

34. Usaf Ee-3

35. Cas-156-57-0

36. Cysteaminhydrochlorid

37. Cysteaminhydrochlorid [german]

38. Ccris 3926

39. Eta-mercaptoethylamine Hydrochloride

40. 1-aminoethane-2-thiol Hydrochloride

41. Einecs 205-858-1

42. Nsc 21116

43. Unii-if1b771svb

44. 1-amino-2-mercaptoethane Hydrochloride

45. Ci 9148

46. Ethylamine, 2-mercapto-, Hydrochloride

47. Cysteamine-hcl

48. Ai3-26089

49. Ccris 3619

50. Beta-mercaptoaethylamin Chlorhydrat [german]

51. A-889

52. Beta-mercaptoaethylamin Chlorhydrat

53. Cystaran (tn)

54. Decarboxycystine Hcl

55. Cym-h.hcl

56. Cystadrops

57. Cysteamine Hydrochoride

58. 2-aminoethanethiol-hcl

59. Cysteamine, Hydrochloride

60. Spectrum2_001667

61. Spectrum3_000992

62. Spectrum4_001120

63. Spectrum5_001422

64. (beta)-mea Hydrochloride

65. Ec 205-858-1

66. Schembl51598

67. Kbiogr_001600

68. Mls000028734

69. Cysteamine Hcl [inci]

70. Decarboxycysteine Hydrochloride

71. Spectrum1504226

72. 2-aminoethanthiol Hydrochloride

73. Spbio_001853

74. Mercaptamine; Mea Hydrochloride

75. Chembl1256137

76. Dtxsid8045779

77. 2-amino-ethanethiol Hydrochloride

78. 2-aminoethanethiol, Hydrochloride

79. B-mercaptoethylamine Hydrochloride

80. Kbio3_001903

81. 2-mercaptoethanamine Hydrochloride

82. A-mercaptoethylamine Hydrochloride

83. Cysteamine Hydrochloride, Bioxtra

84. Hms1922h05

85. Pharmakon1600-01504226

86. Bcp15033

87. Hydrochloric Acid 2-aminoethanethiol

88. Tox21_111245

89. Tox21_500749

90. Ac-301

91. Ccg-39094

92. Cysteamine Hydrochloride [mi]

93. Nsc758692

94. S4206

95. Akos007929948

96. Tox21_111245_1

97. Lp00749

98. 2-aminoethanethiol Hydrochloride (1:1)

99. Cysteamine Hydrochloride [vandf]

100. Ncgc00015691-06

101. Ncgc00094090-02

102. Ncgc00094090-03

103. Ncgc00094090-04

104. Ncgc00261434-01

105. As-12111

106. Hy-77591

107. Mercaptamine Hydrochloride [mart.]

108. Smr000059101

109. 2-aminoethanethiol Chloride;cysteamine Hcl

110. Cysteamine Hydrochloride, >=97.0% (rt)

111. Mercaptamine Hydrochloride [who-dd]

112. Db-043323

113. A0296

114. Cysteamine Hydrochloride, Analytical Standard

115. Eu-0100749

116. Ft-0611242

117. Sw219210-1

118. Cysteamine Hydrochloride [orange Book]

119. Cysteamine Hydrochloride, >=98% (titration)

120. Ethanethiol, 2-amino-, Hydrochloride (1:1)

121. A16474

122. C-9520

123. D03635

124. D70222

125. M 6500

126. A809757

127. Sr-01000075546-1

128. Q27280697

129. Cysteamine Hydrochloride, Vetec(tm) Reagent Grade, 98%

130. F2191-0299

131. Cysteamine Hydrochloride, Pharmagrade, Manufactured Under Appropriate Controls For Use As Raw Material In Pharma Or Biopharmaceutical Production.

132. Cysteamine Hydrochloride, Pharmagrade, Manufactured Under Appropriate Gmp Controls For Pharma Or Biopharmaceutical Production

2.4 Create Date
2005-07-19
3 Chemical and Physical Properties
Molecular Weight 113.61 g/mol
Molecular Formula C2H8ClNS
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count2
Rotatable Bond Count1
Exact Mass113.0065981 g/mol
Monoisotopic Mass113.0065981 g/mol
Topological Polar Surface Area27 Ų
Heavy Atom Count5
Formal Charge0
Complexity10
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameCystaran
PubMed HealthCysteamine (Into the eye)
Drug ClassesOphthalmologic Agent
Drug LabelCYSTARAN is a sterile ophthalmic solution containing 6.5 mg/mL of cysteamine hydrochloride, equivalent to 4.4 mg/mL of cysteamine (0.44%) as the active ingredient. Cysteamine is a cystine-depleting agent which lowers the cystine content of cells in p...
Active IngredientCysteamine hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.44% base
Market StatusPrescription
CompanySigma Tau

2 of 2  
Drug NameCystaran
PubMed HealthCysteamine (Into the eye)
Drug ClassesOphthalmologic Agent
Drug LabelCYSTARAN is a sterile ophthalmic solution containing 6.5 mg/mL of cysteamine hydrochloride, equivalent to 4.4 mg/mL of cysteamine (0.44%) as the active ingredient. Cysteamine is a cystine-depleting agent which lowers the cystine content of cells in p...
Active IngredientCysteamine hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.44% base
Market StatusPrescription
CompanySigma Tau

4.2 Drug Indication

Cystadrops is indicated for the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Cystine Depleting Agents

Compounds and drugs that react with CYSTINE and convert it into a compound that can be more easily metabolized or intracellularly transported. Drugs in this class have been used to treat CYSTINOSIS. (See all compounds classified as Cystine Depleting Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Cystine Disulfide Reduction [MoA]; Cystine Depleting Agent [EPC]
5.3 ATC Code

S01XA21


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01-Jan-2022
27-Dec-2024
KGS
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FDF Dossiers

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01

Recordati

Italy
Specialty & Agro Chemical
Not Confirmed
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Recordati

Italy
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Specialty & Agro Chemical
Not Confirmed

CYSTEAMINE HYDROCHLORIDE

Brand Name : CYSTADROPS

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.37% BASE

Packaging :

Approval Date : 2020-08-19

Application Number : 211302

Regulatory Info : RX

Registration Country : USA

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02

SIGMA TAU

U.S.A
Specialty & Agro Chemical
Not Confirmed
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SIGMA TAU

U.S.A
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Specialty & Agro Chemical
Not Confirmed

CYSTEAMINE HYDROCHLORIDE

Brand Name : CYSTARAN

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.44% BASE

Packaging :

Approval Date : 2012-10-02

Application Number : 200740

Regulatory Info : RX

Registration Country : USA

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03

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed

Cysteamine Hydrochloride

Brand Name : CYSTAMIN

Dosage Form : Eye Drop Solution

Dosage Strength : 0.55%

Packaging : 5 ml / HDPE Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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04

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed

Cysteamine Hydrochloride

Brand Name : CYSTAMIN

Dosage Form : Eye Drop Solution

Dosage Strength : 0.55%

Packaging : 5 ml / HDPE Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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FDA Orange Book

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01

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed

CYSTEAMINE HYDROCHLORIDE

Brand Name : CYSTADROPS

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.37% BASE

Approval Date : 2020-08-19

Application Number : 211302

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
Not Confirmed

CYSTEAMINE HYDROCHLORIDE

Brand Name : CYSTARAN

Dosage Form : SOLUTION/DROPS;OPHTHALMIC

Dosage Strength : EQ 0.44% BASE

Approval Date : 2012-10-02

Application Number : 200740

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Europe

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01

Specialty & Agro Chemical
Not Confirmed
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Specialty & Agro Chemical
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Cysteamine Hydrochloride

Brand Name : CYSTAMIN

Dosage Form : Eye Drop Solution

Dosage Strength : 0.55%

Packaging : 5 ml / HDPE Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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Cysteamine Hydrochloride

Brand Name : CYSTAMIN

Dosage Form : Eye Drop Solution

Dosage Strength : 0.55%

Packaging : 5 ml / HDPE Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Turkey

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01

Specialty & Agro Chemical
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Specialty & Agro Chemical
Not Confirmed

Cysteamine Hydrochloride

Dosage : Eye Drop Solution

Dosage Strength : 0.55%

Brand Name : CYSTAMIN

Approval Date :

Application Number :

Registration Country : Turkey

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Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination
The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   

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12 Sep 2024

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Looking for 156-57-0 / Cysteamine Hydrochloride API manufacturers, exporters & distributors?

Cysteamine Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Cysteamine 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 Cysteamine Hydrochloride manufacturer or Cysteamine Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cysteamine Hydrochloride manufacturer or Cysteamine Hydrochloride supplier.

PharmaCompass also assists you with knowing the Cysteamine Hydrochloride API Price utilized in the formulation of products. Cysteamine Hydrochloride API Price is not always fixed or binding as the Cysteamine Hydrochloride Price is obtained through a variety of data sources. The Cysteamine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Cysteamine Hydrochloride

Synonyms

156-57-0, 2-aminoethanethiol hydrochloride, Cysteamine hcl, 2-mercaptoethylamine hydrochloride, Mercaptamine hydrochloride, Bekaptan

Cas Number

156-57-0

Unique Ingredient Identifier (UNII)

IF1B771SVB

About Cysteamine Hydrochloride

A mercaptoethylamine compound that is endogenously derived from the COENZYME A degradative pathway. The fact that cysteamine is readily transported into LYSOSOMES where it reacts with CYSTINE to form cysteine-cysteamine disulfide and CYSTEINE has led to its use in CYSTINE DEPLETING AGENTS for the treatment of CYSTINOSIS.

Cysteamine Hydrochloride Manufacturers

A Cysteamine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cysteamine Hydrochloride, including repackagers and relabelers. The FDA regulates Cysteamine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cysteamine 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 Cysteamine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Cysteamine Hydrochloride Suppliers

A Cysteamine Hydrochloride supplier is an individual or a company that provides Cysteamine Hydrochloride active pharmaceutical ingredient (API) or Cysteamine Hydrochloride finished formulations upon request. The Cysteamine Hydrochloride suppliers may include Cysteamine Hydrochloride API manufacturers, exporters, distributors and traders.

click here to find a list of Cysteamine Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Cysteamine Hydrochloride USDMF

A Cysteamine Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Cysteamine Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Cysteamine Hydrochloride DMFs exist exist since differing nations have different regulations, such as Cysteamine Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Cysteamine Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Cysteamine Hydrochloride USDMF includes data on Cysteamine Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cysteamine Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Cysteamine Hydrochloride suppliers with USDMF on PharmaCompass.

Cysteamine Hydrochloride JDMF

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 Cysteamine Hydrochloride Drug Master File in Japan (Cysteamine Hydrochloride JDMF) empowers Cysteamine 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 Cysteamine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Cysteamine 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 Cysteamine Hydrochloride suppliers with JDMF on PharmaCompass.

Cysteamine Hydrochloride NDC

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 Cysteamine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Cysteamine Hydrochloride API and other APIs are published in this directory by the FDA.

Unfinished drugs

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 Cysteamine 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.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Cysteamine Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cysteamine Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Cysteamine Hydrochloride suppliers with NDC on PharmaCompass.

Cysteamine Hydrochloride GMP

Cysteamine 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 Cysteamine 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 Cysteamine Hydrochloride GMP manufacturer or Cysteamine Hydrochloride GMP API supplier for your needs.

Cysteamine Hydrochloride CoA

A Cysteamine Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Cysteamine Hydrochloride's compliance with Cysteamine Hydrochloride specifications and serves as a tool for batch-level quality control.

Cysteamine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Cysteamine 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.

Cysteamine Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Cysteamine Hydrochloride EP), Cysteamine Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cysteamine Hydrochloride USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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