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Chemistry

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Also known as: 28860-95-9, Lodosyn, Carbidopa anhydrous, (s)-(-)-carbidopa, (s)-carbidopa, S-(-)-carbidopa
Molecular Formula
C10H14N2O4
Molecular Weight
226.23  g/mol
InChI Key
TZFNLOMSOLWIDK-JTQLQIEISA-N
FDA UNII
KR87B45RGH

Carbidopa
An inhibitor of DOPA DECARBOXYLASE that prevents conversion of LEVODOPA to dopamine. It is used in PARKINSON DISEASE to reduce peripheral adverse effects of LEVODOPA. It has no anti-parkinson activity by itself.
1 2D Structure

Carbidopa

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-3-(3,4-dihydroxyphenyl)-2-hydrazinyl-2-methylpropanoic acid
2.1.2 InChI
InChI=1S/C10H14N2O4/c1-10(12-11,9(15)16)5-6-2-3-7(13)8(14)4-6/h2-4,12-14H,5,11H2,1H3,(H,15,16)/t10-/m0/s1
2.1.3 InChI Key
TZFNLOMSOLWIDK-JTQLQIEISA-N
2.1.4 Canonical SMILES
CC(CC1=CC(=C(C=C1)O)O)(C(=O)O)NN
2.1.5 Isomeric SMILES
C[C@](CC1=CC(=C(C=C1)O)O)(C(=O)O)NN
2.2 Other Identifiers
2.2.1 UNII
KR87B45RGH
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Carbidopa, (r)-isomer

2. Carbidopa, (s)-isomer

3. Lodosin

4. Lodosyn

5. Methyldopahydrazine

6. Mk 485

7. Mk 486

8. Mk-485

9. Mk-486

10. Mk485

11. Mk486

2.3.2 Depositor-Supplied Synonyms

1. 28860-95-9

2. Lodosyn

3. Carbidopa Anhydrous

4. (s)-(-)-carbidopa

5. (s)-carbidopa

6. S-(-)-carbidopa

7. Alpha-methyldopahydrazine

8. L-alpha-methyldopahydrazine

9. N-aminomethyldopa

10. Carbidopum

11. Carbidopum [inn-latin]

12. Carbidopa (anhydrous)

13. S(-)-carbidopa

14. Mk 486

15. (2s)-3-(3,4-dihydroxyphenyl)-2-hydrazinyl-2-methylpropanoic Acid

16. Carbidopa [inn]

17. L-3-(3,4-dihydroxyphenyl)-2-methyl-2-hydrazinopropionic Acid

18. (2s)-3-(3,4-dihydroxyphenyl)-2-hydrazino-2-methylpropanoic Acid

19. (-)-l-alpha-hydrazino-3,4-dihydroxy-alpha-methylhydrocinnamic Acid

20. (s)-3-(3,4-dihydroxyphenyl)-2-hydrazinyl-2-methylpropanoic Acid

21. Kr87b45rgh

22. (alphas)-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic Acid

23. Chebi:39585

24. 28860-95-9 (anhydrous)

25. Ncgc00024596-05

26. Hadrazino-alpha-methyldopa

27. C-dopa

28. 3,3,3-trideuterio-2-[dideuterio-(3,4-dihydroxyphenyl)methyl]-2-hydrazinylpropanoic Acid

29. Smr000058235

30. Ccris 5093

31. Sr-01000597655

32. Einecs 249-271-9

33. Unii-kr87b45rgh

34. Benzenepropanoic Acid, .alpha.-hydrazino-3,4-dihydroxy-.alpha.-methyl-, (s)-

35. Alpha-hydrazino-alpha-methyl-beta-(3,4-dihydroxyphenyl)propionic Acid

36. L-alpha-methyl-alpha-hydrazino-beta-(3,4-dihydroxyphenylpropionic Acid

37. L-alpha-methyl-beta-(3,4-dihydroxyphenyl)-alpha-hydrazinopropionic Acid

38. Mfcd00069231

39. Nd0611

40. Tocris-0455

41. C-126

42. Dsstox_cid_2735

43. Carbidopa [who-dd]

44. Dsstox_rid_76707

45. Dsstox_gsid_22735

46. Lopac0_000382

47. Schembl35084

48. Mls000069628

49. Mls002207014

50. S-(-)-carbidopa Monohydrate

51. Gtpl5159

52. Carbidopa, L- Anhydrous

53. Carbidopa Anhydrous [mi]

54. Chembl1201236

55. Dtxsid4022735

56. Hms2089b12

57. Hms3266a20

58. Hms3411m13

59. Hms3655g20

60. Hms3675m13

61. Hms3713l10

62. Hms3884m14

63. Hy-b0311

64. Tox21_110910

65. (2s)-3-(3,4-dihydroxyphenyl)-2-hydrazino-2-methyl-propanoic Acid

66. Bdbm50418773

67. Nsc751137

68. S1891

69. Zinc19168887

70. Akos015969657

71. Benzenepropanoic Acid, Alpha-hydrazino-3,4-dihydroxy-alpha-methyl-, (s)-

72. Hydrocinnamic Acid, Alpha-hydrazino-3,4-dihydroxy-alpha-methyl-, L-

73. Ac-1676

74. Ccg-204476

75. Db00190

76. Sdccgmls-0072919.p025

77. Mls-0072919

78. Smp1_000057

79. Ncgc00024596-01

80. Ncgc00024596-03

81. Ncgc00024596-06

82. Ncgc00024596-07

83. Ncgc00024596-08

84. As-16862

85. Bc164279

86. Mls-0072919.p013

87. Cas-28860-95-9

88. Eu-0100382

89. Sw199080-2

90. 60c959

91. Ab00441332-05

92. Ab00441332-06

93. Ab00441332_07

94. Ab00441332_08

95. Sr-01000597655-1

96. Sr-01000597655-3

97. Sr-01000597655-5

98. Sr-01000597655-9

99. Brd-k78712176-001-07-5

100. Benzenepropanoic Acid, A-hydrazino-3,4-dihydroxy-a-methyl-

101. (-)-l-alpha-hydrazino-3,4-dihydroxy-alpha-methylhydrocinamic Acid

102. (s)-?-hydrazino-?-methyl-?-(3,4-dihydroxyphenyl)propionic Acid

103. (s)-3-(3,4-dihydroxyphenyl)-2-hydrazino-2-methylpropionic Acid

104. (s)-3-(3,4-dihydroxyphenyl)-2-hydrazinyl-2-methylpropanoicacid

105. (2s)-3-(3,4-dihydroxyphenyl)-2-hydrazinyl-2-methyl-propanoic Acid

106. (2s)-3-(3,4-dihydroxyphenyl)-2-hydrazino-2-methylpropionic Acid Monohydrate

107. Benzenepropanoic Acid, .alpha.-hydrazinyl-3,4-dihydroxy-.alpha.-methyl-, (.alpha.s)-

108. Kinson; 3-(3,4-dihydroxy-phenyl)-2-hydrazino-2-methyl-propionic Acid

109. 1426847-87-1

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 226.23 g/mol
Molecular Formula C10H14N2O4
XLogP3-2.2
Hydrogen Bond Donor Count5
Hydrogen Bond Acceptor Count6
Rotatable Bond Count4
Exact Mass226.09535693 g/mol
Monoisotopic Mass226.09535693 g/mol
Topological Polar Surface Area116 Ų
Heavy Atom Count16
Formal Charge0
Complexity261
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameCarbidopa
PubMed HealthCarbidopa (By mouth)
Drug ClassesAntiparkinsonian
Drug LabelCarbidopa and levodopa extended release tablets are extended release combination of carbidopa and levodopa for the treatment of Parkinsons disease and syndrome.Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline...
Active IngredientCarbidopa
Dosage FormTablet
RouteOral
Strength25mg
Market StatusPrescription
CompanyAmerigen Pharms

2 of 4  
Drug NameLodosyn
PubMed HealthCarbidopa (By mouth)
Drug ClassesAntiparkinsonian
Drug LabelCarbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as ()-L--hydrazino--methyl--(3,4-dihydroxybenzene) pro...
Active IngredientCarbidopa
Dosage FormTablet
RouteOral
Strength25mg
Market StatusPrescription
CompanyAton

3 of 4  
Drug NameCarbidopa
PubMed HealthCarbidopa (By mouth)
Drug ClassesAntiparkinsonian
Drug LabelCarbidopa and levodopa extended release tablets are extended release combination of carbidopa and levodopa for the treatment of Parkinsons disease and syndrome.Carbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline...
Active IngredientCarbidopa
Dosage FormTablet
RouteOral
Strength25mg
Market StatusPrescription
CompanyAmerigen Pharms

4 of 4  
Drug NameLodosyn
PubMed HealthCarbidopa (By mouth)
Drug ClassesAntiparkinsonian
Drug LabelCarbidopa, an inhibitor of aromatic amino acid decarboxylation, is a white, crystalline compound, slightly soluble in water, with a molecular weight of 244.3. It is designated chemically as ()-L--hydrazino--methyl--(3,4-dihydroxybenzene) pro...
Active IngredientCarbidopa
Dosage FormTablet
RouteOral
Strength25mg
Market StatusPrescription
CompanyAton

4.2 Drug Indication

Carbidopa is indicated with [levodopa] for the treatment of symptoms of idiopathic Parkinson disease, postencephalitic parkinsonism and symptomatic parkinsonism followed by carbon monoxide or manganese intoxication. The combination therapy is administered for the reduction of [levodopa]-driven nausea and vomiting. The product of carbidopa should be used in patients where the combination therapy of carbidopa/[levodopa] provide less than the adequate daily dosage. As well carbidopa can be used in patients where the dosages of carbidopa and [levodopa] require individual titration.


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

When mixed with [levodopa], carbidopa inhibits the peripheral conversion of [levodopa] to dopamine and the decarboxylation of [oxitriptan] to serotonin by aromatic L-amino acid decarboxylase. This results in an increased amount of [levodopa] and [oxitriptan] available for transport to the central nervous system. Carbidopa also inhibits the metabolism of [levodopa] in the GI tract, thus, increasing the bioavailability of [levodopa]. The presence of additional units of circulating [levodopa] can increase the effectiveness of the still functional dopaminergic neurons and it has been shown to alleviate symptoms for a time. The action of carbidopa is very important as [levodopa] is able to cross the blood-brain barrier while dopamine cannot. Hence the administration of carbidopa is essential to prevent the transformation of external [levodopa] to dopamine before reaching the main action site in the brain. The coadministration of carbidopa with [levodopa] has been shown to increase the half-life of [levodopa] more than 1.5 times while increasing the plasma level and decreasing clearance. The combination therapy has also shown an increase of the recovery of [levodopa] in urine instead of dopamine which proves a reduced metabolism. This effect has been highly observed by a significant reduction in [levodopa] requirements and a significant reduction in the presence of side effects such as nausea. It has been observed that the effect of carbidopa is not dose-dependent.


5.2 MeSH Pharmacological Classification

Antiparkinson Agents

Agents used in the treatment of Parkinson's disease. The most commonly used drugs act on the dopaminergic system in the striatum and basal ganglia or are centrally acting muscarinic antagonists. (See all compounds classified as Antiparkinson Agents.)


Aromatic Amino Acid Decarboxylase Inhibitors

Compounds and drugs that block or inhibit the enzymatic action of AROMATIC AMINO ACID DECARBOXYLASES. Pharmaceutical agents in this category are used in conjunction with LEVODOPA in order to slow its metabolism. (See all compounds classified as Aromatic Amino Acid Decarboxylase Inhibitors.)


Dopamine Agents

Any drugs that are used for their effects on dopamine receptors, on the life cycle of dopamine, or on the survival of dopaminergic neurons. (See all compounds classified as Dopamine Agents.)


5.3 Absorption, Distribution and Excretion

Absorption

When [levodopa]/carbidopa is administered orally, 40-70% of the administered dose is absorbed. Once absorbed, carbidopa shows bioavailability of 58%. A maximum concentration of 0.085 mcg/ml was achieved after 143 min with an AUC of 19.28 mcg.min/ml.


Route of Elimination

In animal studies, 66% of the administered dose of carbidopa was eliminated via the urine while 11% was found in feces. These studies were performed in humans and it was observed a urine excretion covering 50% of the administered dose.


Volume of Distribution

The volume of distribution reported for the combination therapy of carbidopa/[levodopa] is of 3.6 L/kg. However, carbidopa is widely distributed in the tissues, except in the brain. After one hour, carbidopa is found mainly in the kidney, lungs, small intestine and liver.


Clearance

The reported clearance rate for the combination therapy of [levodopa]/carbidopa is 51.7 L/h.


5.4 Metabolism/Metabolites

The loss of the hydrazine functional group (probably as molecular nitrogen) represents the major metabolic pathway for carbidopa. There are several metabolites of carbidopa metabolism including 3-(3,4-dihydroxyphenyl)-2-methylpropionic acid, 3-(4-hydroxy-3-methoxyphenyl)-2-methylpropionic acid, 3-(3-hydroxyphenyl)-2-methylpropionic acid, 3-(4-hydroxy-3-methoxyphenyl)-2-methyllactic acid, 3-(3-hydroxyphenyl)-2-methyllactic acid, and 3,4-dihydroxyphenylacetone (1,2).


5.5 Biological Half-Life

The reported half-life of carbidopa is of approximately 107 minutes.


5.6 Mechanism of Action

Carbidopa is an inhibitor of the DDC which in order, inhibits the peripheral metabolism of levodopa. DDC is very important in the biosynthesis of L-tryptophan to serotonin and the modification of L-DOPA to dopamine. DDC can be found in the body periphery and in the blood-brain barrier. The action of carbidopa is focused on peripheral DDC as this drug cannot cross the blood-brain barrier. Hence, it will prevent the metabolism of [levodopa] in the periphery but it will not have any activity on the generation of dopamine in the brain.


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TECHNOLOGY CO., L","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"75.00","actualQuantity":"75","unit":"KGS","unitRateFc":"255","totalValueFC":"19386.1","currency":"USD","unitRateINR":"22389","date":"09-Mar-2025","totalValueINR":"1679175","totalValueInUsd":"19386.1","indian_port":"Ahmedabad Air","hs_no":"29280090","bill_no":"8788811","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"TD NO 7 DONGHAI 4TH ROAD TAIZHOU B AY ECONOMIC AND TECHNOGICAL DEVELOP MENT ZONE LINHAI TAIZHOU ZHEJIANG P CHINA","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743186600,"product":"CARBIDOPA ( QTY 50 KGS) BATCH NO:CAA-20240104 CARBIDOPA ( QTY 50 KGS) BATCH NO:CAA-20240104","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"ZHEJIANG CHIRAL MEDICINE CHEMICALS CO","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"330","totalValueFC":"16630","currency":"USD","unitRateINR":"28809","date":"29-Mar-2025","totalValueINR":"1440450","totalValueInUsd":"16630","indian_port":"Ahmedabad Air","hs_no":"29280090","bill_no":"9192292","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NANYANG ECONOMY DEVELOPMENT ZONE XI AOSHAN HANGZHOU ZHEJIANG CHINA SDNF CHINA","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1743359400,"product":"CARBIDOPA IP (4 DRUMS) IUPAC NAME: 2-(3,4-DIHYDROXYBENZYL)-2-HYDRAZINOPR OPIONIC ACID MONOHYDRATE CAS NO.: 38821-49-7 (RCARBIDOPA IP (4 DRUMS) IUPAC NAME: 2-(3,4-DIHYDROXYBENZYL)-2","address":"Unit No. 309, 3rd Floor, Adani Insp","city":"Mumbai","supplier":"ZHEJIANG WILD WIND PHARMACEUTICAL CO","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ASCENDAS PANVEL FTWZ PRIVATE LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"235","totalValueFC":"23685.1","currency":"USD","unitRateINR":"20515.5","date":"31-Mar-2025","totalValueINR":"2051550","totalValueInUsd":"23685.1","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29280090","bill_no":"9207416","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Beijiang Industrial Zone Geshan Tow n Dongyang Zhejiang, , CHINA SDNF CHINA","customerAddress":"Unit No. 309, 3rd Floor, Adani Insp"}]
11-Jan-2021
31-Mar-2025
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG;100MG

USFDA APPLICATION NUMBER - 17555

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DOSAGE - TABLET;ORAL - 25MG;100MG

USFDA APPLICATION NUMBER - 17555

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DOSAGE - TABLET;ORAL - 25MG;250MG

USFDA APPLICATION NUMBER - 17555

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DOSAGE - TABLET;ORAL - 25MG

USFDA APPLICATION NUMBER - 17830

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19856

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DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 19856

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 23....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG

USFDA APPLICATION NUMBER - 203312

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG

USFDA APPLICATION NUMBER - 203312

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 48....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG

USFDA APPLICATION NUMBER - 203312

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DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG

USFDA APPLICATION NUMBER - 203312

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DOSAGE - TABLET;ORAL - 12.5MG;200MG;50MG

USFDA APPLICATION NUMBER - 21485

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DOSAGE - TABLET;ORAL - 18.75MG;200MG;75MG

USFDA APPLICATION NUMBER - 21485

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DOSAGE - TABLET;ORAL - 25MG;200MG;100MG

USFDA APPLICATION NUMBER - 21485

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DOSAGE - TABLET;ORAL - 31.25MG;200MG;125MG

USFDA APPLICATION NUMBER - 21485

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DOSAGE - TABLET;ORAL - 37.5MG;200MG;150MG

USFDA APPLICATION NUMBER - 21485

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DOSAGE - TABLET;ORAL - 50MG;200MG;200MG

USFDA APPLICATION NUMBER - 21485

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ABOUT THIS PAGE

Looking for 28860-95-9 / Carbidopa API manufacturers, exporters & distributors?

Carbidopa manufacturers, exporters & distributors 1

64

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

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

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

API | Excipient name

Carbidopa

Synonyms

28860-95-9, Lodosyn, Carbidopa anhydrous, (s)-(-)-carbidopa, (s)-carbidopa, S-(-)-carbidopa

Cas Number

28860-95-9

Unique Ingredient Identifier (UNII)

KR87B45RGH

About Carbidopa

An inhibitor of DOPA DECARBOXYLASE that prevents conversion of LEVODOPA to dopamine. It is used in PARKINSON DISEASE to reduce peripheral adverse effects of LEVODOPA. It has no anti-parkinson activity by itself.

Lodosyn Manufacturers

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

Lodosyn Suppliers

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

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

Lodosyn USDMF

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

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

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

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

Lodosyn KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Lodosyn Drug Master File in Korea (Lodosyn KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lodosyn. The MFDS reviews the Lodosyn KDMF as part of the drug registration process and uses the information provided in the Lodosyn KDMF to evaluate the safety and efficacy of the drug.

After submitting a Lodosyn KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Lodosyn API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Lodosyn suppliers with KDMF on PharmaCompass.

Lodosyn CEP

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

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

Lodosyn WC

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

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

Lodosyn 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 Lodosyn as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Lodosyn GMP

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

Lodosyn CoA

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

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

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