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1 EU WC
7 KDMF
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18 Listed Suppliers
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343 FDF Dossiers
118 FDA Orange Book
167 Europe
17 Canada
12 South Africa
29 Listed Dossiers

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TABLET;ORAL - 10MG;100MG
TABLET;ORAL - 25MG;100MG
TABLET;ORAL - 25MG;250MG
TABLET;ORAL - 25MG
TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG
CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG
CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG
CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG
TABLET;ORAL - 12.5MG;200MG;50MG
TABLET;ORAL - 18.75MG;200MG;75MG
TABLET;ORAL - 25MG;200MG;100MG
TABLET;ORAL - 31.25MG;200MG;125MG
TABLET;ORAL - 37.5MG;200MG;150MG
TABLET;ORAL - 50MG;200MG;200MG

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2 Evonik
4 Rochem International Inc
20 SPI Pharma
2 Seqens
5 DKSH
7 Faran Shimi Pharmaceutical
8 Boai NKY Pharmaceuticals Ltd
1 Chynops Pharma
15 Gangwal Healthcare
5 Nanjing Well Pharmaceutical
2 Pfanstiehl
1 Capital Farma
1 ACG Worldwide
8 Actylis
1 Aeon Procare
2 Alcedo Pharmachem
10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
29 BASF
12 Corel Pharma Chem
6 DFE Pharma
1 Finar
12 Gangwal Chemicals
11 Ideal Cures Pvt Ltd
5 Ingredion Pharma Solutions
33 Kerry
5 Kima Chemical
6 Lonza Capsugel
17 Microlex e.U
1 Nanjing Bold Chemical
1 NEWEDGE Overseas
2 Nomisma Healthcare
4 Novo Excipients
5 Pharmatrans-Sanaq
8 Pluviaendo
5 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
29 Roquette
13 Seppic
7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shanghai Welltone Material Technology Co., Ltd
2 Shijiazhuang Huaxu Pharmaceutical
12 Sigachi Industries
4 The Dow Chemical Company
2 Ulanqab Kema New Material
4 Vasa Pharmachem
1 Vertellus
1 Zhejiang Huakang Pharmaceutical

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DIGITAL CONTENT

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5 DATA COMPILATION #PharmaFlow
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GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 150 Finished Drug Prices, 11 Annual Reports

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9 US Medicaid Prescriptions
150 Finished Drug Prices
11 Annual Reports

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11 APIs, 9 FDF Dossiers

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9 FDF Dossiers

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4 US Exclusivities

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ANALYTICAL

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Synopsis

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343

FDF Dossiers

118

FDA Orange Book

167

Europe

Canada

Australia

South Africa

Listed Dossiers

28DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

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121

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

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News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

242,873,433

Annual Reports (USD Million)

3,785

Finished Drug Prices

336 RELATED EXCIPIENT COMPANIES

570EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₁₀H₁₄N₂O₄
Molecular Weight	226.23 g/mol
XLogP3	-2.2
Hydrogen Bond Donor Count	5
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	4
Exact Mass	226.09535693 g/mol
Monoisotopic Mass	226.09535693 g/mol
Topological Polar Surface Area	116 Å²
Heavy Atom Count	16
Formal Charge	0
Complexity	261
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	Carbidopa
PubMed Health	Carbidopa (By mouth)
Drug Classes	Antiparkinsonian
Drug Label	Carbidopa 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 Ingredient	Carbidopa
Dosage Form	Tablet
Route	Oral
Strength	25mg
Market Status	Prescription
Company	Amerigen Pharms

2 of 4
Drug Name	Lodosyn
PubMed Health	Carbidopa (By mouth)
Drug Classes	Antiparkinsonian
Drug Label	Carbidopa, 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 Ingredient	Carbidopa
Dosage Form	Tablet
Route	Oral
Strength	25mg
Market Status	Prescription
Company	Aton

3 of 4
Drug Name	Carbidopa
PubMed Health	Carbidopa (By mouth)
Drug Classes	Antiparkinsonian
Drug Label	Carbidopa 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 Ingredient	Carbidopa
Dosage Form	Tablet
Route	Oral
Strength	25mg
Market Status	Prescription
Company	Amerigen Pharms

4 of 4
Drug Name	Lodosyn
PubMed Health	Carbidopa (By mouth)
Drug Classes	Antiparkinsonian
Drug Label	Carbidopa, 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 Ingredient	Carbidopa
Dosage Form	Tablet
Route	Oral
Strength	25mg
Market Status	Prescription
Company	Aton

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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PU DONG","supplierAddress":"BEIJIANG INDUSTRIAL ZONE, DONGYANG,ZHEJIANG PROV.CHINA Dongyang, , China China","customerAddress":"102,TITAN HOUSE,60 FEET RD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724092200,"product":"CARBIDOPA (BULK DRUG)","address":"102,TITAN HOUSE,60 FEET RD,","city":"MUMBAI, MAHARASHTRA","supplier":"ZHEJIANG WILD WIND PHARMACEUTICAL CO","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"TITAN LABORATORIES","customerCountry":"INDIA","quantity":"142.86","actualQuantity":"142.86","unit":"KGS","unitRateFc":"250","totalValueFC":"36128.6","currency":"USD","unitRateINR":"21212.5","date":"20-Aug-2024","totalValueINR":"3030417.75","totalValueInUsd":"36128.6","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"5147778","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"BEIJIANG INDUSTRIAL ZONE, DONGYANG,ZHEJIANG PROV.CHINA Dongyang, , China China","customerAddress":"102,TITAN HOUSE,60 FEET RD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724092200,"product":"CARBIDOPA BP CARBIDOPA BP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"ZHEJIANG WILD WIND PHARMACEUTICAL CO","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"AQUATIC REMEDIES PVT LTD","customerCountry":"INDIA","quantity":"425.00","actualQuantity":"425","unit":"KGS","unitRateFc":"242","totalValueFC":"104041.2","currency":"USD","unitRateINR":"20533.7","date":"20-Aug-2024","totalValueINR":"8726822.5","totalValueInUsd":"104041.2","indian_port":"ARSHIYA-SEZ\/PANVEL","hs_no":"29333990","bill_no":"5143120","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHENGDU","supplierAddress":"BEIJIANG INDUSTRIAL ZONE DONGYANG Z HEJIANG PROV.CHINA Shanghai, , CHIN A CHINA","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1724092200,"product":"CARBIDOPA BP CARBIDOPA BP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"ZHEJIANG WILD WIND PHARMACEUTICAL CO","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"AQUATIC REMEDIES PVT LTD","customerCountry":"INDIA","quantity":"42.00","actualQuantity":"42","unit":"KGS","unitRateFc":"242","totalValueFC":"10281.7","currency":"USD","unitRateINR":"20533.7","date":"20-Aug-2024","totalValueINR":"862415.4","totalValueInUsd":"10281.7","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29333990","bill_no":"5147079","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHENGDU","supplierAddress":"BEIJIANG INDUSTRIAL ZONE DONGYANG Z HEJIANG PROV.CHINA Shanghai, , CHIN A CHINA","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727461800,"product":"CARBIDOPA (BATCH NO: C02-20240809)","address":"C-4, INDUSTRIAL AREA","city":"HYDERABAD, ANDHRA PRADESH","supplier":"ZHEJIANG CHEMICALS I & E CORP","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SRI KRISHNA PHARMACEUTICALS","customerCountry":"INDIA","quantity":"16.00","actualQuantity":"16","unit":"KGS","unitRateFc":"290","totalValueFC":"4684.2","currency":"USD","unitRateINR":"24534","date":"28-Sep-2024","totalValueINR":"392544","totalValueInUsd":"4684.2","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"5846434","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"10F, BUILDING 4,TAIPING FINANCE TOW ER,NO.199 SHIMIN STREET,SHANGCHENG DISTRICT,HANGZHOU CHINA China","customerAddress":"C-4, INDUSTRIAL AREA"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1728498600,"product":"CARBIDOPA USP","address":"221, GOREGAON-MULUND LINK ROAD,","city":"BHANDUP WEST, MUMBAI","supplier":"M\/S. ZHEJIANG CHIRAL MEDICINE CHEMICALS CO. LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"RUBICON RESEARCH LIMITED","customerCountry":"INDIA","quantity":"706.80","actualQuantity":"706.8","unit":"KGS","unitRateFc":"290","totalValueFC":"206980.7","currency":"USD","unitRateINR":"24606.5","date":"10-Oct-2024","totalValueINR":"17391874.2","totalValueInUsd":"206980.7","indian_port":"Bombay Air","hs_no":"29336990","bill_no":"6058938","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"NANYANG ECONOMY DEVELOPMENT ZONE, XIAOSHAN, HANGZHOU ZHEJIANG, CHINA CN","customerAddress":"221, GOREGAON-MULUND LINK ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729017000,"product":"CARBIDOPA","address":"8-2-334 SDE SERENE CHAMBERS,3RD FL","city":"HYDERABAD,TELANGANA","supplier":"ZHEJIANG CHIRAL MEDICINE CHEMICALS CO","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SUVEN PHARMACEUTICALS","customerCountry":"INDIA","quantity":"1.53","actualQuantity":"1.53","unit":"KGS","unitRateFc":"308","totalValueFC":"475.9","currency":"USD","unitRateINR":"26133.8","date":"16-Oct-2024","totalValueINR":"39984.71","totalValueInUsd":"475.9","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"6156649","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Nanyang Economy Development Zone, x iaoshan Hangzhou zhejiang SDNF China","customerAddress":"8-2-334 SDE SERENE CHAMBERS,3RD FL"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729017000,"product":"CARBIDOPA","address":"8-2-334 SDE SERENE CHAMBERS,3RD FL","city":"HYDERABAD,TELANGANA","supplier":"ZHEJIANG CHIRAL MEDICINE CHEMICALS CO","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SUVEN PHARMACEUTICALS","customerCountry":"INDIA","quantity":"7.26","actualQuantity":"7.26","unit":"KGS","unitRateFc":"308","totalValueFC":"2258","currency":"USD","unitRateINR":"26133.8","date":"16-Oct-2024","totalValueINR":"189731.39","totalValueInUsd":"2258","indian_port":"Hyderabad Air","hs_no":"29420090","bill_no":"6156649","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Nanyang Economy Development Zone, x iaoshan Hangzhou zhejiang SDNF China","customerAddress":"8-2-334 SDE SERENE CHAMBERS,3RD FL"}]

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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Drugs in Development

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 10MG;100MG

USFDA APPLICATION NUMBER - 17555

DOSAGE - TABLET;ORAL - 25MG;100MG

USFDA APPLICATION NUMBER - 17555

DOSAGE - TABLET;ORAL - 25MG;250MG

USFDA APPLICATION NUMBER - 17555

DOSAGE - TABLET;ORAL - 25MG

USFDA APPLICATION NUMBER - 17830

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

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

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

USFDA APPLICATION NUMBER - 203312

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

USFDA APPLICATION NUMBER - 203312

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

USFDA APPLICATION NUMBER - 203312

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

USFDA APPLICATION NUMBER - 203312

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

USFDA APPLICATION NUMBER - 21485

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

USFDA APPLICATION NUMBER - 21485

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

USFDA APPLICATION NUMBER - 21485

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

USFDA APPLICATION NUMBER - 21485

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

USFDA APPLICATION NUMBER - 21485

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

USFDA APPLICATION NUMBER - 21485

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DATA COMPILATION #PharmaFlow

FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder). Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period. Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.

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Global Sales Information

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US Medicaid Prescriptions

01

Brand Name : Carbidopa

Country

CPHI Middle east

Not Confirmed

Not Confirmed

Only 10 entries up to this point, click to access all

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Finished Drug Prices

01

Brand Name : Duodopa

U.S.A

CPHI Middle east

Not Confirmed

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U.S.A

Virtual Booth

Digital Content

RX/OTC/DISCN : Class H

AbbVie

Etilevodopa; Carbidopa

Dosage Form : Levodopa+Carbidopa 20Mg/Ml + 5Mg...

Dosage Strength : 7 bags intestinal gel 100 ml 20 mg/ml + 5 ...

Price Per Pack (Euro) : 1,126.05

Published in :

Country : Italy

RX/OTC/DISCN : Class H

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02

Brand Name : Corbilta

Finland

CPHI Middle east

Not Confirmed

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Finland

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RX/OTC/DISCN : Class A

ORION CORPORATION

Etilevodopa; Carbidopa; Entacapone

Dosage Form : Levodopa+Carbidopa+Entacapone 10...

Dosage Strength : 100 CPR 100 mg + 25 mg + 200 mg

Price Per Pack (Euro) : 57.86

Published in :

Country : Italy

RX/OTC/DISCN : Class A

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03

Brand Name : CORBILTA

Finland

CPHI Middle east

Not Confirmed

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RX/OTC/DISCN :

ORION CORPORATION

Etilevodopa; Carbidopa; Entacapone

Dosage Form : Film-Coated Tablet

Dosage Strength : 100 mg + 25 mg + 200 mg

Price Per Pack (Euro) : 57.86

Published in :

Country : Italy

RX/OTC/DISCN :

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04

Brand Name : STALEVO

Finland

CPHI Middle east

Not Confirmed

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RX/OTC/DISCN :

ORION CORPORATION

Etilevodopa; Carbidopa; Entacapone

Dosage Form : Film-Coated Tablet

Dosage Strength : 100 mg + 25 mg + 200 mg

Price Per Pack (Euro) : 110.22

Published in :

Country : Italy

RX/OTC/DISCN :

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Corporate PDF

05

Brand Name : CORBILTA

Finland

CPHI Middle east

Not Confirmed

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Finland

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RX/OTC/DISCN :

ORION CORPORATION

Etilevodopa; Carbidopa; Entacapone

Dosage Form : Film-Coated Tablet

Dosage Strength : 200 mg/50 mg/200 mg

Price Per Pack (Euro) : 57.86

Published in :

Country : Italy

RX/OTC/DISCN :

Portfolio PDF

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Corporate PDF

06

Brand Name : STALEVO

Finland

CPHI Middle east

Not Confirmed

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Finland

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RX/OTC/DISCN :

ORION CORPORATION

Etilevodopa; Carbidopa; Entacapone

Dosage Form : Film-Coated Tablet

Dosage Strength : 200 mg/50 mg/200 mg

Price Per Pack (Euro) : 110.22

Published in :

Country : Italy

RX/OTC/DISCN :

Portfolio PDF

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07

Brand Name : CORBILTA

Finland

CPHI Middle east

Not Confirmed

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Finland

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Digital Content

RX/OTC/DISCN :

ORION CORPORATION

Etilevodopa; Carbidopa; Entacapone

Dosage Form : Film-Coated Tablet

Dosage Strength : 50 mg/12.5 mg/200 mg

Price Per Pack (Euro) : 57.86

Published in :

Country : Italy

RX/OTC/DISCN :

Portfolio PDF

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08

Brand Name : STALEVO

Finland

CPHI Middle east

Not Confirmed

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Finland

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Digital Content

RX/OTC/DISCN :

ORION CORPORATION

Etilevodopa; Carbidopa; Entacapone

Dosage Form : Film-Coated Tablet

Dosage Strength : 50 mg/12.5 mg/200 mg

Price Per Pack (Euro) : 110.22

Published in :

Country : Italy

RX/OTC/DISCN :

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Corporate PDF

09

Brand Name : CORBILTA

Finland

CPHI Middle east

Not Confirmed

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RX/OTC/DISCN :

ORION CORPORATION

Etilevodopa; Carbidopa; Entacapone

Dosage Form : Film-Coated Tablet

Dosage Strength : 75 mg/18.75 mg/200 mg

Price Per Pack (Euro) : 57.86

Published in :

Country : Italy

RX/OTC/DISCN :

Portfolio PDF

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Corporate PDF

10

Brand Name : STALEVO

Finland

CPHI Middle east

Not Confirmed

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Finland

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Digital Content

RX/OTC/DISCN :

ORION CORPORATION

Etilevodopa; Carbidopa; Entacapone

Dosage Form : Film-Coated Tablet

Dosage Strength : 75 mg/18.75 mg/200 mg

Price Per Pack (Euro) : 110.22

Published in :

Country : Italy

RX/OTC/DISCN :

Portfolio PDF

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Only 10 entries up to this point, click to access all

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Annual Reports

01 Brand Name : Duodopa

U.S.A

CPHI Middle east

Not Confirmed

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Abbvie

Carbidopa

Main Therapeutic Indication : CNS & Anesthesia

Currency : USD

2020 Revenue in Millions : 494

2019 Revenue in Millions : 461

Growth (%) : 7

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02 Brand Name : Duodopa

U.S.A

CPHI Middle east

Not Confirmed

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AbbVie

Carbidopa

Main Therapeutic Indication : Neurology

Currency : USD

2021 Revenue in Millions : 511

2020 Revenue in Millions : 494

Growth (%) : 3

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03 Brand Name : Duodopa

U.S.A

CPHI Middle east

Not Confirmed

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U.S.A

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AbbVie

Carbidopa

Main Therapeutic Indication : Neurology

Currency : USD

2022 Revenue in Millions : 458

2021 Revenue in Millions : 511

Growth (%) : -10

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04 Brand Name : Duodopa

U.S.A

CPHI Middle east

Not Confirmed

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AbbVie

Carbidopa

Main Therapeutic Indication : Neurology

Currency : USD

2023 Revenue in Millions : 468

2022 Revenue in Millions : 458

Growth (%) : 2

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05 Brand Name : Duodopa

U.S.A

CPHI Middle east

Not Confirmed

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U.S.A

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Abbvie

Carbidopa/Levodopa

Main Therapeutic Indication : Neurological/Mental Disorders

Currency : USD

2017 Revenue in Millions : 355

2016 Revenue in Millions : 293

Growth (%) : 21

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06 Brand Name : Duodopa

U.S.A

CPHI Middle east

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U.S.A

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Abbvie

Carbidopa/Levodopa

Main Therapeutic Indication : Neurological/Mental Disorders

Currency : USD

2016 Revenue in Millions : 293

2015 Revenue in Millions : 231

Growth (%) : 27

Product Web Link

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07 Brand Name : Duodopa

U.S.A

CPHI Middle east

Not Confirmed

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U.S.A

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AbbVie

Carbidopa/Levodopa

Main Therapeutic Indication : Neuroscience and Mental Health

Currency : USD

2015 Revenue in Millions : 220

2014 Revenue in Millions : 231

Growth (%) : 5%

Product Web Link

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08 Brand Name : Duodopa

U.S.A

CPHI Middle east

Not Confirmed

Contact Supplier

U.S.A

Virtual Booth

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Abbvie

Carbidopa/Levodopa

Main Therapeutic Indication : Neurological/Mental Disorders

Currency : USD

2018 Revenue in Millions : 430

2017 Revenue in Millions : 355

Growth (%) : 21%

Product Web Link

Corporate PDF

09 Brand Name : Duodopa

U.S.A

CPHI Middle east

Not Confirmed

Contact Supplier

U.S.A

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AbbVie

Carbidopa

Main Therapeutic Indication : CNS & Anesthesia

Currency : USD

2019 Revenue in Millions : 461

2018 Revenue in Millions : 430

Growth (%) : 7

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10 Brand Name : Duodopa

U.S.A

CPHI Middle east

Not Confirmed

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U.S.A

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AbbVie

Carbidopa/Levodopa

Main Therapeutic Indication : Neuroscience/Mental Health

Currency : USD

2014 Revenue in Millions : 23.60%

2013 Revenue in Millions :

Growth (%) :

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APIs

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FDF DOSSIERS

Various Finished Dosage Formulations needed in India [ENA14778]

A company that provides consultancy services to the pharmaceutical, neutraceutical, cosmetics and medical devices industries is looking for suppliers of Various Finished Dosage Formulations for commercial purpose. The required quantity is 10,000 units for each. The suppliers must support this enquiry with GMP & CoA. 1. Carbidopa and Levodopa (25 mg/ 100 mg, 10 mg/ 100 mg & 25 mg/ 250 mg) Film-coated Tablets 2. Carbidopa and Levodopa (50 mg/ 200 mg & 25 mg/ 100 mg) Controlled Released Tablets

23 Aug 2022

Various Finished Dosage Formulations needed in Vietnam [ENA12551]

A company that deals in the distribution of a wide range of products in allopathic formulations, herbal formulations, nutraceuticals, vaccines and orthopedic implants is looking for suppliers of Various Finished Dosage Formulations for commercial purpose. The required quantity is 500,000 units for each. 1. Imipenem (250 mg & 500 mg) + Cilastatin (250 mg & 500 mg) Injections or Infusions 2. Ketoconazole (200 mg) Suppositories 3. Letrozole (2.5 mg) Tablets 4. Levodopa (100 mg & 250 mg) + Carbidopa (10 mg & 25 mg) Tablets 5. Levofloxacin (500 mg/ 100 ml) Injections or Infusions 6. Levofloxacin (5%) Eye Drops

29 Jan 2022

Various Finished Dosage Formulations needed in Mexico [ENA11413]

A company that deals in the trading of medicines and medical products is looking for suppliers of Various Finished Dosage Formulations for commercial purpose. The suppliers must support this enquiry with FDA. 1. Linagliptin (5 mg) Tablets. The required quantity is 100,000 units. 2. Adalimumab (40 mg/ 0.8 ml) Pre-filled Syringe or Ampoules. The required quantity is 300 units. 3. Levodopa (250 mg) and Carbidopa (25 mg) Tablets. The required quantity is 2,000 units 4. Cyclophosphamide (200 mg) Lyophilized Ampoules. The required quantity is 2,000 units.

16 Sep 2021

Tender// Various Finished Dosage Formulations needed in Poland [ENA11289]

University Hospital In Krakow is looking for supplies of Various Finished Dosage Formulations for commercial purpose. The deadline is 22-Sep-2021. 1. Darbepoetin Alfa (500 mcg / ml in 1 ml) Solution for Injection. The required quantity is 100 units. 2. Bortezomib (3.5 mg) Powder for Solution for Injection. The required quantity is 1,800 units. 3. Certolizumab Pegol (200 mg / ml) Solution for Injection. The required quantity is 450 units. 4. Levodopa (20 mg) + Carbidopa (5 mg / ml) Enteric Gel. The required quantity is 1,000 units. 5. Nilotinib (200 mg) Hard Capsules. The required quantity is 650 units. 6. Pertuzumab (420 mg /14 ml) Concentrate for Solution for Infusion. The required quantity is 1,000 units. 7. Fosfomycin (4 g) Powder for Solution for Infusion. The required quantity is 3,600 units.

03 Sep 2021

Tender// Levodopa + Carbidopa Intestinal Gel needed in Russia [ENA09660]

Health Committee is looking for supplies of Levodopa (20 mg/ ml) + Carbidopa (5 mg/ ml) Intestinal Gel. The required quantity is 385,000 units. The deadline is 12-Feb-2021.

05 Feb 2021

Tender// Various Formulations needed in Mauritius [ENA05763]

16 Nov 2019

Levodopa, Mitomycin and other formulations needed in Iran [ENA03585]

An Iranian private finished pharmaceutical products importing company is looking for suppliers/manufacturers of below formulations: 1- Levodopa + Benserazide cap/tab 2- Levodopa + Carbidopa + Entacapone cap/tab 3- Mitomycin injection 4- Tetanus Immunoglobulin 5- Anti Rh 6- Dacarbazine 7- Ifosfamide 8- Iodixanol 9- Iopromide 10- Surfactant (bovine or non-bovine) 11- Mitoxantron 12- Peg Interferon

04 Mar 2019

Enquiry// Lamotrigine 50 mg, Topiramate and other finished dosage formulations needed in the Middle East [ENA00377]

MENA Business Consulting & Solutions is searching for suppliers of following products for supply to one of their clients: 1. Lamotrigine 50 mg (Lamictal) 120,000 Units 2. Topiramate 50 mg (Topamax) 100,000 Units 3. Topiramate 25 mg (Topamax) 50,000 Units 4. Topiramate 100 mg (Topamax) 50,000 Units 5. Thiamine 100 mg (Vitamin B1) 39,300 Units 6. Lamotrigine 100 mg (Lamictal) 36,000 Units 7. Irbesartan 300 mg + Hydrochlorothiazide 12.5 mg (Avapro) 20,000 Units 8. Etoposide 50 mg (Toposar) 2,000 Units 9. Fluticasone 50 mg + Salmeterol 25 mg (Flonase) 1000 Units 10. Levetiracetam 100 mg (Keppra) 800 Units 11. Carbidopa 5 mg + Levodopa 20 mg/ml (Duodopa) 119 Units Interested suppliers/manufacturers should contact Dr. Khattab Qattan via Email: kuqattan@aol.com or Tel: 8053125702.

27 Jun 2017

Enquiry//eCTD Dossiers required for various products [ENA00027]

Bilcare, a reliable and credible long-term partner of the global pharmaceutical industry for Clinical Trial Material Supplies has received requests for the following products - 1. Colesevalam tablets 625 mg for US market. 2. Nitrofurantoin capsules 50/ 100mg for UK, South Africa, Italy and Croatia markets 3. Cetirizine tablets 20 mg for Canada /Us/EU market 4. Colchicine tablets 0.5 mg for UK market 5. Carbimazole tablets 5 & 20 mg for UK market 6. Tolterodine ER capsule 2/4 mg for US market 7. Sevelamer Carbonate tablets 800 mg for US market 8. Sevelamer suspension for US 9. Carbidopa tablets for EU. 10. Azithromycin 250 mg capsules for EU 11. Mesalamine 1200 mg tabs for EU 12. Mesalazine 400 mg and 800 mg for EU 13. Alimemazine 10mg tab for EU 14. Hydrocortisone 10 mg tab for EU 15. Diclofenac sod.3%, sodium hyaluronate 2.5% (Solaraze) for EU 16. Ciprofibrate 100 mg tab for EU 17. Hydroxy urea capsules for US/EU 18. Tamoxifen citrate tabs for US/EU 19. Gefitinib tabs for US/EU 20. Sunitinib capsules for US/EU 21. Lacosamide for EU 22. Aripiprazole tabs for US 23. Darifenacin ER for US 24. Memantine tablets 5/10mg, Oral solution 2mg/ml, ER capsules 7/14/21/28mg for US, 25. Memantine ER + Donepezil capsules 14mg+10mg/ 28mg+10mg for US Interested companies should respond immediately to Chhanda Das, VP-QA and Regulatory, Bilcare Limited at Chhanda.Das_GCS@bilcare.com.

04 Jul 2016

CARBIDOPA; LEVODOPA

CPHI Middle east

Not Confirmed

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

39 API Suppliers

20 USDMF

17 CEP/COS

8 JDMF

1 EU WC

7 KDMF

14 NDC API

18 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

28 Drugs in Development

FINISHED DOSAGE FORMULATIONS

343 FDF Dossiers

118 FDA Orange Book

167 Europe

17 Canada

12 South Africa

29 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG;100MG

TABLET;ORAL - 25MG;100MG

TABLET;ORAL - 25MG;250MG

TABLET;ORAL - 25MG

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

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

CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG

CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG

CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG

CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG

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

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

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

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

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

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

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

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