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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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KURLA ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744050600,"product":"CARBIDOPA IP CARBIDOPA IP","address":"ACME PLAZA , ANDHERI KURLA ROAD","city":"MUMBAI","supplier":"ZHEJIANG WILD WIND PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SUN PHARMA LABORATORIES LIMITED","customerCountry":"INDIA","quantity":"1175.00","actualQuantity":"1175","unit":"KGS","unitRateFc":"230","totalValueFC":"273401.4","currency":"USD","unitRateINR":"19918","date":"08-Apr-2025","totalValueINR":"23403650","totalValueInUsd":"273401.4","indian_port":"JNPT","hs_no":"29280090","bill_no":"9370128","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"BEIJIANG INDUSTRIAL ZONE, GESHAN TO WN, DONGYANG ZHEJIANG PROV.CHINA SDNF China","customerAddress":"ACME PLAZA , ANDHERI KURLA ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745346600,"product":"CARBIDOPA IP (2 DRM)(BOE NO-1010075 ,DT:05\/08\/2024) (USED FOR PHARMACEUTICAL PRODUCT) (IUPAC NAME- (2S)-3-)3,4-DIHYDROXYCARBIDOPA IP (2 DRM)(BOE NO-1010075 ,DT:05\/08\/2024) (USED FO","address":"305 AGGARWAL CITY SQUARE","city":"DELHI","supplier":"SHAH TC GLOBAL EXIM LLP","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SHAH TC DISTRIBUTION LLP","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"255","totalValueFC":"12868.9","currency":"USD","unitRateINR":"22032","date":"23-Apr-2025","totalValueINR":"1101600","totalValueInUsd":"12868.9","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29280090","bill_no":"9657384","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"UNIT NO. 142, 1ST FLOOR, ADMINISTRA TIVE BUILDING, , ARSHIYA FTWZ VILLA GE SAI TALUKA PANVEL,MAHARASHTRA, N INDIA","customerAddress":"305 AGGARWAL CITY SQUARE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745346600,"product":"CARBIDOPA USP,IUPAC -2S-3-3-4 DI HYDROCYPHENYL-2,HYDROZINO-2-METHYLPRO PANOIC ACID MONOHYDRATE","address":"8-2-334 SDE SERENE CHAMBERS,3RD FL","city":"HYDERABAD,TELANGANA","supplier":"ZHEJIANG CHIRAL MEDICINE CHEMICALS CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SUVEN PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"300","totalValueFC":"15139.9","currency":"USD","unitRateINR":"25920","date":"23-Apr-2025","totalValueINR":"1296000","totalValueInUsd":"15139.9","indian_port":"GMR HYDERABAD AVIATION-SEZ","hs_no":"29280090","bill_no":"9659066","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NANYANG ECONOMY DEVELOPMENT ZONE XIAOSHAN,HANGZHOU SDNF China","customerAddress":"8-2-334 SDE SERENE CHAMBERS,3RD FL"}]
    06-Jan-2022
    30-Apr-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

    11

    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.

    Atamet Manufacturers

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

    Atamet Suppliers

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

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

    Atamet USDMF

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

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

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

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

    Atamet KDMF

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

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

    After submitting a Atamet 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 Atamet API can apply through the Korea Drug Master File (KDMF).

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

    Atamet CEP

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

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

    Atamet WC

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

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

    Atamet 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 Atamet as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Atamet GMP

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

    Atamet CoA

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

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

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