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25 API Suppliers, 17 USDMF, 3 CEP/COS, 4 EU WC, 16 NDC API, 9 Listed Suppliers, $ API Reference Price

25 API Suppliers
17 USDMF
3 CEP/COS
4 EU WC
16 NDC API
9 Listed Suppliers
$ API Reference Price

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6 Drugs in Development

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2 Intermediates Suppliers

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26 FDF Dossiers, 15 FDA Orange Book, 1 Canada, 4 Australia, 1 South Africa, 5 Listed Dossiers

26 FDF Dossiers
15 FDA Orange Book
1 Canada
4 Australia
1 South Africa
5 Listed Dossiers

RELATED EXCIPIENT COMPANIES

6 DKSH, 1 Faran Shimi Pharmaceutical, 1 Gangwal Healthcare, 4 ACG Worldwide, 1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 1 Gangwal Chemicals, 3 Kerry, 3 Lonza Capsugel, 5 Microlex e.U, 1 Pluviaendo, 1 Prachin Chemical, 1 Qualicaps, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Vasa Pharmachem

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6 DKSH
1 Faran Shimi Pharmaceutical
1 Gangwal Healthcare
4 ACG Worldwide
1 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
2 BASF
1 Gangwal Chemicals
3 Kerry
3 Lonza Capsugel
5 Microlex e.U
1 Pluviaendo
1 Prachin Chemical
1 Qualicaps
3 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Vasa Pharmachem

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10 Fillers, Diluents & Binders, 8 Empty Capsules, 8 Lubricants & Glidants, 6 Coating Systems & Additives, 5 Thickeners and Stabilizers, 4 Co-Processed Excipients, 3 Direct Compression, 2 Film Formers & Plasticizers, 2 Granulation, 2 Coloring Agents, 2 Controlled & Modified Release, 1 Taste Masking, 1 Emulsifying Agents

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10 Fillers, Diluents & Binders
8 Empty Capsules
8 Lubricants & Glidants
6 Coating Systems & Additives
5 Thickeners and Stabilizers
4 Co-Processed Excipients
3 Direct Compression
2 Film Formers & Plasticizers
2 Granulation
2 Coloring Agents
2 Controlled & Modified Release
1 Taste Masking
1 Emulsifying Agents

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1 DATA COMPILATION #PharmaFlow
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3 US Medicaid Prescriptions, 2 Finished Drug Prices, 4 Annual Reports

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3 US Medicaid Prescriptions
2 Finished Drug Prices
4 Annual Reports

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10 APIs, 7 FDF Dossiers

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10 APIs
7 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM , 2 USP , 3 Others

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2 USP
3 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 1,322

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API

FDF

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FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

6DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

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US Patents

US Exclusivities

Health Canada Patents

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GLOBAL SALES INFORMATION

US Medicaid (USD)

13,375,304

Annual Reports (USD Million)

319

Finished Drug Prices

35 RELATED EXCIPIENT COMPANIES

54EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: D-penicillamine, 52-67-5, Cuprimine, D-(-)-penicillamine, 3-mercapto-d-valine, Depen

Molecular Formula

C₅H₁₁NO₂S

Molecular Weight

149.21 g/mol

InChI Key

VVNCNSJFMMFHPL-VKHMYHEASA-N

FDA UNII

GNN1DV99GX

3-Mercapto-D-valine. The most characteristic degradation product of the penicillin antibiotics. It is used as an antirheumatic and as a chelating agent in Wilson's disease.

Penicillamine is an Antirheumatic Agent.

1 2D Structure

Penicillamine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(2S)-2-amino-3-methyl-3-sulfanylbutanoic acid

2.1.2 InChI

InChI=1S/C5H11NO2S/c1-5(2,9)3(6)4(7)8/h3,9H,6H2,1-2H3,(H,7,8)/t3-/m0/s1

2.1.3 InChI Key

VVNCNSJFMMFHPL-VKHMYHEASA-N

2.1.4 Canonical SMILES

CC(C)(C(C(=O)O)N)S

2.1.5 Isomeric SMILES

CC(C)([C@H](C(=O)O)N)S

2.2 Other Identifiers

2.2.1 UNII

GNN1DV99GX

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Beta,beta Dimethylcysteine

2. Beta,beta-dimethylcysteine

3. Copper Penicillaminate

4. Cuprenil

5. Cuprimine

6. D 3 Mercaptovaline

7. D Penicillamine

8. D-3-mercaptovaline

9. D-penicillamine

10. Dimethylcysteine

11. Mercaptovaline

12. Metalcaptase

13. Penicillaminate, Copper

2.3.2 Depositor-Supplied Synonyms

1. D-penicillamine

2. 52-67-5

3. Cuprimine

4. D-(-)-penicillamine

5. 3-mercapto-d-valine

6. Depen

7. Cuprenil

8. D-penamine

9. (-)-penicillamine

10. Artamine

11. (2s)-2-amino-3-methyl-3-sulfanylbutanoic Acid

12. D-valine, 3-mercapto-

13. Kuprenil

14. Mercaptyl

15. Perdolat

16. Trolovol

17. D-3-mercaptovaline

18. (s)-3,3-dimethylcysteine

19. Penicilamina

20. Penicillaminum

21. 3-sulfanyl-d-valine

22. D-beta,beta-dimethylcysteine

23. D-mercaptovaline

24. Penicillamin

25. Beta-thiovaline

26. Metalcaptase

27. (d)-penicillamine

28. Beta,beta-dimethylcysteine

29. D-penicilamine

30. (s)-2-amino-3-mercapto-3-methylbutanoic Acid

31. Penicillamina [dcit]

32. Distamine

33. Penicilamina [inn-spanish]

34. Penicillaminum [inn-latin]

35. Cupripen

36. Depamine

37. Pendramine

38. Chebi:7959

39. (s)-penicillamine

40. Penicillamine (cuprimine)

41. Reduced Penicillamine

42. Sufirtan

43. Gnn1dv99gx

44. Chembl1430

45. Reduced D-penicillamine

46. 3,3-dimethyl-d-cysteine

47. Nsc-81549

48. (s)-penicillamin

49. D,3-mercaptovaline

50. Ncgc00024359-04

51. Penicillamina

52. Mfcd00064302

53. Sufortan

54. Cuprimine (tn)

55. Valine, 3-mercapto-, D-

56. Ccris 2904

57. D-beta-mercaptovaline

58. Depen (tn)

59. Hsdb 3378

60. Sr-01000000262

61. Einecs 200-148-8

62. Unii-gnn1dv99gx

63. Nsc 81549

64. Alpha-amino-beta-methyl-beta-mercaptobutyric Acid

65. (2s)-2-amino-3-methyl-3-sulfanyl-butanoic Acid

66. Distamine (*hydrochloride*)

67. D-penicillamin

68. Penicillamine (jan/usp/inn)

69. Dimethyl Cysteine

70. Metalcaptase (*hydrochloride*)

71. Penicillamine-(d)

72. 3-thio-d-valine

73. Penicillamine,(s)

74. D-(-)-2-amino-3-mercapto-3-methylbutanoic Acid

75. Nsc81549

76. Penicillamine-(racemic)

77. Spectrum_000283

78. Penicillamine [usan:usp:inn:ban:jan]

79. Spectrum2_001029

80. Spectrum3_000541

81. Spectrum4_000470

82. Spectrum5_001196

83. Penicillamine [mi]

84. Epitope Id:113237

85. P-1280

86. Penicillamine [inn]

87. Penicillamine [jan]

88. Schembl4343

89. Dsstox_cid_17069

90. Dsstox_rid_79300

91. Penicillamine [hsdb]

92. Penicillamine [usan]

93. Dsstox_gsid_37069

94. Bspbio_002181

95. Kbiogr_000920

96. Kbioss_000763

97. Penicillamine [vandf]

98. Cid_92173

99. Divk1c_000314

100. Penicillamine [mart.]

101. Spbio_001217

102. D-penicillamine, 98-101%

103. Penicillamine [usp-rs]

104. Penicillamine [who-dd]

105. Gtpl7264

106. Dtxsid6037069

107. Bdbm39346

108. Kbio1_000314

109. Kbio2_000763

110. Kbio2_003331

111. Kbio2_005899

112. Kbio3_001681

113. Ninds_000314

114. Zinc114127

115. Penicillamine [ep Impurity]

116. Penicillamine [orange Book]

117. Bcp17247

118. Hy-b0300

119. Str02534

120. Penicillamine [ep Monograph]

121. Tox21_110899

122. Bdbm50217941

123. Penicillamine [usp Monograph]

124. S1853

125. Akos006237201

126. Zinc100509167

127. Am83710

128. Ccg-266197

129. Db00859

130. Cas-52-67-5

131. Idi1_000314

132. Smp1_000042

133. Ncgc00018283-01

134. Ncgc00024359-05

135. Ncgc00024359-06

136. P0147

137. En300-52608

138. C07418

139. D00496

140. M06142

141. P15236

142. 064p302

143. Q421239

144. Sr-01000000262-3

145. Sr-01000000262-4

146. (2s)-2-amino-3-mercapto-3-methyl-butyric Acid;hydrochloride

147. (2s)-2-amino-3-mercapto-3-methylbutanoic Acid;hydrochloride

148. (2s)-2-azanyl-3-methyl-3-sulfanyl-butanoic Acid;hydrochloride

149. Penicillamine, European Pharmacopoeia (ep) Reference Standard

150. (2s)-2-amino-3-methyl-3-sulfanylbutanoic Acid3-sulfanyl-d-valine

151. Penicillamine, United States Pharmacopeia (usp) Reference Standard

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₅H₁₁NO₂S
Molecular Weight	149.21 g/mol
XLogP3	-1.8
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	4
Rotatable Bond Count	2
Exact Mass	149.05104977 g/mol
Monoisotopic Mass	149.05104977 g/mol
Topological Polar Surface Area	64.3 Å²
Heavy Atom Count	9
Formal Charge	0
Complexity	124
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	1

4 Drug and Medication Information

4.1 Drug Information

1 of 4
Drug Name	Cuprimine
PubMed Health	Penicillamine (By mouth)
Drug Classes	Antirheumatic, Heavy Metal Chelator, Renal-Urologic Agent
Drug Label	Penicillamine is a chelating agent used in the treatment of Wilson's disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIO
Active Ingredient	Penicillamine
Dosage Form	Capsule
Route	Oral
Strength	250mg
Market Status	Prescription
Company	Aton

2 of 4
Drug Name	Depen
PubMed Health	Penicillamine (By mouth)
Drug Classes	Antirheumatic, Heavy Metal Chelator, Renal-Urologic Agent
Drug Label	DESCRIPTION - Penicillamine is 3-mercapto-D-valine, a disease modifying antirheumatic drug. It is a white or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and ca...
Active Ingredient	Penicillamine
Dosage Form	Tablet
Route	Oral
Strength	250mg
Market Status	Prescription
Company	Meda Pharms

3 of 4
Drug Name	Cuprimine
PubMed Health	Penicillamine (By mouth)
Drug Classes	Antirheumatic, Heavy Metal Chelator, Renal-Urologic Agent
Drug Label	Penicillamine is a chelating agent used in the treatment of Wilson's disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy (see INDICATIO
Active Ingredient	Penicillamine
Dosage Form	Capsule
Route	Oral
Strength	250mg
Market Status	Prescription
Company	Aton

4 of 4
Drug Name	Depen
PubMed Health	Penicillamine (By mouth)
Drug Classes	Antirheumatic, Heavy Metal Chelator, Renal-Urologic Agent
Drug Label	DESCRIPTION - Penicillamine is 3-mercapto-D-valine, a disease modifying antirheumatic drug. It is a white or practically white, crystalline powder, freely soluble in water, slightly soluble in alcohol, and insoluble in ether, acetone, benzene, and ca...
Active Ingredient	Penicillamine
Dosage Form	Tablet
Route	Oral
Strength	250mg
Market Status	Prescription
Company	Meda Pharms

4.2 Therapeutic Uses

Antidotes; Antirheumatic Agents; Chelating Agents

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)

THE D ISOMER IS USED CLINICALLY, ALTHOUGH THE L ISOMER ALSO FORMS CHELATION COMPLEXES. PENICILLAMINE IS EFFECTIVE CHELATOR OF COPPER, MERCURY, ZINC, & LEAD & PROMOTES EXCRETION OF THESE METALS IN URINE.

Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1610

THERE IS SOME PROMISE IN TREATMENT OF RHEUMATOID ARTHRITIS WITH PENICILLAMINE. ... BENEFICIAL EFFECT IS SEEN ONLY AFTER SEVERAL WK OF TREATMENT, & ARTHRITIC SYMPTOMS RETURN IF DRUG IS WITHDRAWN PREMATURELY.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 920

PENICILLAMINE HAS BECOME ESTABLISHED IN TREATMENT OF CYSTINURIA & ASSOC NEPHROLITHIASIS. IN DOSE OF 30 MG/KG/DAY, IT LOWERS OR ELIMINATES URINARY CYSTINE & PREVENTS FURTHER STONE DEVELOPMENT.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 920

For more Therapeutic Uses (Complete) data for (D)-PENICILLAMINE (11 total), please visit the HSDB record page.

4.3 Drug Warning

VET: USE IN PREGNANCY IS CONTRAINDICATED BECAUSE OF ITS CHELATING EFFECT ON TRACE METALS.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 417

CROSS SENSITIVITY BETWEEN PENICILLIN & PENICILLAMINE DOES NOT ALWAYS OCCUR; THEREFORE, PENICILLAMINE CAN BE GIVEN CAUTIOUSLY TO PATIENTS WHO ARE HYPERSENSITIVE TO PENICILLIN.

American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991., p. 757

CAREFUL EXAM OF SKIN, AS WELL AS URINALYSIS, DIFFERENTIAL & WHITE BLOOD CELL COUNTS, DIRECT PLATELET COUNTS, & HEMOGLOBIN DETERMINATION SHOULD BE PERFORMED.

American Medical Association. AMA Drug Evaluations Annual 1991. Chicago, IL: American Medical Association, 1991., p. 757

EXPTL, TOXIC EFFECTS IN RATS GIVEN HIGH DOSES OF PENICILLAMINE RESEMBLE THOSE SEEN IN PYRIDOXINE DEFICIENCY, & EFFECTS ARE REVERSED BY FEEDING PYRIDOXINE. IN HUMAN BEINGS, PYRIDOXINE ANTAGONISM IS READILY DEMONSTRATED WITH L & DL FORMS, BUT RARELY WITH D FORM. ... INCR URINARY EXCRETION OF XANTHURENIC ACID & KYNURENINE.

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 919

For more Drug Warnings (Complete) data for (D)-PENICILLAMINE (11 total), please visit the HSDB record page.

4.4 Drug Indication

For treatment of Wilson's disease, cystinuria and active rheumatoid arthritis.

FDA Label

5 Pharmacology and Biochemistry

5.1 Pharmacology

Penicillamine is a chelating agent used in the treatment of Wilson's disease. It is also used to reduce cystine excretion in cystinuria and to treat patients with severe, active rheumatoid arthritis unresponsive to conventional therapy. Penicillamine is used as a form of immunosuppression to treat rheumatoid arthritis. Penicillamine inhibits macrophages, decreases IL-1 and the number of T-lymphocytes, and prevents collagen cross linkage. In Wilson's disease it binds copper, allowing it to be eliminated in the urine.

5.2 MeSH Pharmacological Classification

Antidotes

Agents counteracting or neutralizing the action of POISONS. (See all compounds classified as Antidotes.)

Chelating Agents

Chemicals that bind to and remove ions from solutions. Many chelating agents function through the formation of COORDINATION COMPLEXES with METALS. (See all compounds classified as Chelating Agents.)

Antirheumatic Agents

Drugs that are used to treat RHEUMATOID ARTHRITIS. (See all compounds classified as Antirheumatic Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

PENICILLAMINE

5.3.2 FDA UNII

GNN1DV99GX

5.3.3 Pharmacological Classes

Antirheumatic Agent [EPC]

5.4 ATC Code

M - Musculo-skeletal system

M01 - Antiinflammatory and antirheumatic products

M01C - Specific antirheumatic agents

M01CC - Penicillamine and similar agents

M01CC01 - Penicillamine

5.5 Absorption, Distribution and Excretion

Absorption

rapidly but incompletely

Route of Elimination

Excretion is mainly renal, mainly as disulfides.

HUMAN SUBJECTS SUFFERING FROM WILSON'S DISEASE, RAPIDLY ABSORBED ORAL DOSE OF (35)S DL-PENICILLAMINE. PLASMA CONCN OF (35)S PEAKED WITHIN 60 MIN. (35)S WAS RAPIDLY EXCRETED, ALMOST COMPLETELY IN 24 HR URINE WHERE 73% OF ADMIN (35)S ... RECOVERED. THERE WAS INTERSUBJECT VARIATION IN EXTENT OF BINDING ... BY PLASMA PROTEINS. /DL-PENICILLAMINE/

The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 2: A Review of the Literature Published Between 1970 and 1971. London: The Chemical Society, 1972., p. 135

FROM METABOLIC POINT OF VIEW, D-PENICILLAMINE IS VIRTUALLY INERT, & THIS OBSERVATION IS COMPATIBLE WITH FACT THAT EXTRACELLULAR WATER MAKES UP MAIN DISTRIBUTION VOL FOR D-PENICILLAMINE.

The Chemical Society. Foreign Compound Metabolism in Mammals. Volume 4: A Review of the Literature Published during 1974 and 1975. London: The Chemical Society, 1977., p. 153

PENICILLAMINE IS WELL ABSORBED (40% to70%) FROM GI TRACT &, THEREFORE, HAS DECIDED ADVANTAGE OVER OTHER CHELATING AGENTS. PEAK CONCN IN BLOOD ARE OBTAINED BETWEEN 1 AND 3 HR AFTER ADMINISTRATION. ... /IT/ IS SOMEWHAT RESISTANT TO ATTACK BY CYSTEINE DESULFHYDRASE OR L-AMINO ACID OXIDASE. AS A RESULT ... IS RELATIVELY STABLE IN VIVO. ... HEPATIC BIOTRANSFORMATION IS RESPONSIBLE FOR MOST OF THE DEGRADATION OF PENICILLAMINE, AND VERY LITTLE IS EXCRETED UNCHANGED. METABOLITES ARE FOUND IN BOTH URINE AND FECES.

Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1610

The effects of chelating agents (citric acid, tartaric acid, penicillamine and ethylenediaminetetraacetic acid) and cysteine on the absorption of mercuric chloride were investigated in rats. Perfusion of the small intestine showed that the chelating agents and cysteine decreased the absorption of mercuric chloride depending on their stability of constants wtih Hg2+, under the predominant conditions of water absorption and secretion. The difference in absorption of mercuric chloride between both conditions was inversely correlated with their logarithmic stability constant values. These agents decreased the transport of mercuric chloride through the everted intestinal wall and the uptake of mercuric chloride by the intestinal brush border membrane in a similar manner. From these results, it is suggested that the chelating agents and cysteine decrease the absorption of mercuric chloride through the pores of the brush border membrane due to th solvent drag effect.

PMID:2057447 Endo T et al; Pharmacol Toxicol 68 (3): 171-6 (1991)

For more Absorption, Distribution and Excretion (Complete) data for (D)-PENICILLAMINE (7 total), please visit the HSDB record page.

5.6 Metabolism/Metabolites

Hepatic

The transformation of D-penicillamine was studied in orally and iv dosed rats and in human plasma in vitro. In each case, low molecular weight metabolites (previously identified as disulfides) and a mixed disulfide between D-penicillamine and albumin (D-penicillamine-protein) formed. The rates of D-penicillamine elimination, other than through protein conjugation, were comparable in the rat groups to the rate of oxidation to low molecula weight metabolites in vitro. The rates of transformation to D-penicillamine protein were also comparable in the in vitro preparations and in orally treated rats. These qualitative and quantitative similarities suggest blood plasma may be an important site of transformation in vivo. Extracellular oxidation of D-penicillamine may be linked to its antirheumatic action, either through reduction of oxygen species or through formation of D-penicillamine protein disulfides at surfaces of mononuclear leukocytes.

PMID:2085148 Joyce DA, Murphy BR; Agents Actions 31 (3-4): 353-7 (1990)

5.7 Biological Half-Life

1 hour

5.8 Mechanism of Action

Penicillamine is a chelating agent recommended for the removal of excess copper in patients with Wilson's disease. From in vitro studies which indicate that one atom of copper combines with two molecules of penicillamine. Penicillamine also reduces excess cystine excretion in cystinuria. This is done, at least in part, by disulfide interchange between penicillamine and cystine, resulting in formation of penicillamine-cysteine disulfide, a substance that is much more soluble than cystine and is excreted readily. Penicillamine interferes with the formation of cross-links between tropocollagen molecules and cleaves them when newly formed. The mechanism of action of penicillamine in rheumatoid arthritis is unknown although it appears to suppress disease activity. Unlike cytotoxic immunosuppressants, penicillamine markedly lowers IgM rheumatoid factor but produces no significant depression in absolute levels of serum immunoglobulins. Also unlike cytotoxic immunosuppressants which act on both, penicillamine in vitro depresses T-cell activity but not B-cell activity.

The rationale for ... use in cyctinuria is that penicillamine forms a relatively soluble disulfide compound with cysteine through a disulfide interchange mechanism and thereby decr the formation of cystine containing renal stones.

Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1610

Penicillamine chelates mercury, lead, copper, iron, and probably other heavy metals to form stable, soluble complexes that are readily excreted in the urine.

US Pharmacopeial Convention; US Pharmacopeia Dispensing Information (USP DI); Drug Information for the Health Care Professional 12th ed, V.I p.2158 (1992)

The mechanism of action of penicillamine in rheumatoid arthritis is not known, but may involve improvement of lymphocyte function. It markedly reduces IgM rheumatoid factor and immune complexes in serum and synovial fluid, but does not significantly lower absolute concentrations of serum immunoglobulins. In vitro, penicillamine depresses T-cell but not B-cell activity. However, the relationship of these effects to the activity of penicillamine in rheumatoid arthritis is not known.

US Pharmacopeial Convention; US Pharmacopeia Dispensing Information (USP DI); Drug Information for the Health Care Professional 12th ed, V.I p.2158 (1992)

Antiurolithic (cystine calculi) Penicillamine combines chemically with cystine (cysteine-cysteine disulfide) to form penicillamine cysteine disulfide, which is more soluble than cystine and is readily excreted. As a result, urinary cystine concentrations are lowered and the formation of cystine calculi is prevented. With prolonged treatment, existing cystine calculi may be gradually dissolved.

US Pharmacopeial Convention; US Pharmacopeia Dispensing Information (USP DI); Drug Information for the Health Care Professional 12th ed, V.I p.2158 (1992)

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API Reference Price

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LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1650.5","totalValueFC":"242171.3","currency":"GBP","unitRateINR":"176304.1","date":"24-Mar-2021","totalValueINR":"17630405.6","totalValueInUsd":"242171.3","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"3282717","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"","customerAddress":"781, INDUSTRIAL AREA,PHASE-II,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1643308200,"product":"D-PENICILLAMINE PH EUR (LIST 4\/ITEM NO.69, IGST LIST 1\/ITEMNO.190)","address":"781, INDUSTRIAL AREA,,PHASE-II,","city":"CHANDIGARH,CHANDIGARH","supplier":"BARENTZ UK LIMITED","supplierCountry":"UNITED KINGDOM","foreign_port":"#N\/A","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"1650.5","totalValueFC":"350653.1","currency":"GBP","unitRateINR":"174142.4","date":"28-Jan-2022","totalValueINR":"26121360.67","totalValueInUsd":"350653.1","indian_port":"DELHI AIR","hs_no":"29419090","bill_no":"7269540","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED KINGDOM","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"781, INDUSTRIAL AREA,,PHASE-II,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1665081000,"product":"PENICILLAMINE USP (RE-IMPORT VIDE SB NO.2225315 DT 05.06.2021)","address":"PLOT NO.68 & 69, JUBILEE HEIGHTS,J UBILEE ENCLAVE, MADHAPUR","city":"HYDERABAD,TELANGANA","supplier":"APOTEX INC","supplierCountry":"INDIA","foreign_port":"NA","customer":"VIJAYASRI ORGANICS LIMITED","customerCountry":"INDIA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"2050","totalValueFC":"62647.8","currency":"USD","unitRateINR":"171831","date":"07-Oct-2022","totalValueINR":"5154928.59","totalValueInUsd":"62647.8","indian_port":"HYDERABAD AIR","hs_no":"29420090","bill_no":"2763731","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.68 & 69, JUBILEE HEIGHTS,J UBILEE ENCLAVE, MADHAPUR"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1665081000,"product":"PENICILLAMINE USP (RE-IMPORT VIDE SB NO.2983028 DT 08.07.2021)","address":"PLOT NO.68 & 69, JUBILEE HEIGHTS,J UBILEE ENCLAVE, MADHAPUR","city":"HYDERABAD,TELANGANA","supplier":"APOTEX INC","supplierCountry":"INDIA","foreign_port":"NA","customer":"VIJAYASRI ORGANICS LIMITED","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"2050","totalValueFC":"20882.6","currency":"USD","unitRateINR":"171831","date":"07-Oct-2022","totalValueINR":"1718309.53","totalValueInUsd":"20882.6","indian_port":"HYDERABAD AIR","hs_no":"29420090","bill_no":"2763731","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"PLOT NO.68 & 69, JUBILEE HEIGHTS,J UBILEE ENCLAVE, MADHAPUR"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695148200,"product":"D-PENICILLAMINE","address":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK","city":"KURLA, MUMBAI","supplier":"NINGBO NUOBAI PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"PIRAMAL PHARMA SOLUTIONS","customerCountry":"INDIA","quantity":"0.10","actualQuantity":"0.1","unit":"KGS","unitRateFc":"1500","totalValueFC":"151.7","currency":"USD","unitRateINR":"125925","date":"20-Sep-2023","totalValueINR":"12592.5","totalValueInUsd":"151.7","indian_port":"Madras Air","hs_no":"29339990","bill_no":"7917992","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.21,JIANGXIA ST.NINGBO315000 CHINASDNF CHINA","customerAddress":"PIRAMAL ANANTA, PIRAMAL AGASTYA PARK"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1709145000,"product":"D-PENICILLAMINE (CAS:52-67-5 )","address":"D-44 ZAKIR NAGAR WEST","city":"NEW DELHI","supplier":"HEFEI HOME SUNSHINE ","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"ALCHEMY MEDICINE PRIVATE ","customerCountry":"INDIA","quantity":"20.00","actualQuantity":"20","unit":"KGS","unitRateFc":"365","totalValueFC":"7381.5","currency":"USD","unitRateINR":"30623.5","date":"29-Feb-2024","totalValueINR":"612470","totalValueInUsd":"7381.5","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"2357578","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"LTD.1002, HUANMAO BUILDING, NO.105,,MENGCHENG ROAD, HEFEI CITY, 230061, CHINA","customerAddress":"D-44 ZAKIR NAGAR WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1718044200,"product":"D-PENICILLAMINE PH EUR (AS PER ITEM LIST 4\/ITEM NO.69, IGSTLIST 1\/ITEM NO.190)","address":"781, INDUSTRIAL AREA,","city":"CHANDIGARH.","supplier":"BARENTZ UK LIMITED","supplierCountry":"GERMANY","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"IND SWIFT LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"1895.2","totalValueFC":"190955.3","currency":"GBP","unitRateINR":"212544.5","date":"11-Jun-2024","totalValueINR":"15940838.88","totalValueInUsd":"190955.3","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"3941401","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"OMNIBUS LESBOURNE ROAD REIGATE SURREY RH2 7LD UNITED KINGDOM REIGATE,, UNITED KINGDOM UNITED KINGDOM","customerAddress":"781, INDUSTRIAL AREA,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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ABOUT THIS PAGE

Penicillamine Manufacturers

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

Penicillamine Suppliers

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

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

Penicillamine USDMF

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

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

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

Penicillamine CEP

A Penicillamine CEP of the European Pharmacopoeia monograph is often referred to as a Penicillamine Certificate of Suitability (COS). The purpose of a Penicillamine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Penicillamine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Penicillamine to their clients by showing that a Penicillamine CEP has been issued for it. The manufacturer submits a Penicillamine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Penicillamine CEP holder for the record. Additionally, the data presented in the Penicillamine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Penicillamine DMF.

A Penicillamine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Penicillamine 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 Penicillamine suppliers with CEP (COS) on PharmaCompass.

Penicillamine WC

A Penicillamine written confirmation (Penicillamine WC) is an official document issued by a regulatory agency to a Penicillamine manufacturer, verifying that the manufacturing facility of a Penicillamine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Penicillamine APIs or Penicillamine finished pharmaceutical products to another nation, regulatory agencies frequently require a Penicillamine WC (written confirmation) as part of the regulatory process.

click here to find a list of Penicillamine suppliers with Written Confirmation (WC) on PharmaCompass.

Penicillamine 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 Penicillamine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Penicillamine 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 Penicillamine 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 Penicillamine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Penicillamine NDC to their finished compounded human drug products, they may choose to do so.

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

Penicillamine GMP

Penicillamine 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 Penicillamine 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 Penicillamine GMP manufacturer or Penicillamine GMP API supplier for your needs.

Penicillamine CoA

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

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

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