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Pilocarpine Hydrochloride

LGM Pharma Pilocarpine Hydrochloride

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 8 USDMF, 3 CEP/COS, 1 JDMF, 1 KDMF, 8 NDC API, 8 Listed Suppliers, $ API Reference Price

16 API Suppliers
8 USDMF
3 CEP/COS
1 JDMF
1 KDMF
8 NDC API
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

26 Drugs in Development

26 Drugs in Development

FINISHED DOSAGE FORMULATIONS

70 FDF Dossiers, 29 FDA Orange Book, 23 Europe, 4 Canada, 9 Australia, 4 South Africa, 1 Listed Dossiers

70 FDF Dossiers
29 FDA Orange Book
23 Europe
4 Canada
9 Australia
4 South Africa
1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;OPHTHALMIC - 1%, SOLUTION;OPHTHALMIC - 2%, SOLUTION;OPHTHALMIC - 4%, TABLET;ORAL - 5MG, TABLET;ORAL - 7.5MG

drugProductComposition
SOLUTION;OPHTHALMIC - 1%
SOLUTION;OPHTHALMIC - 2%
SOLUTION;OPHTHALMIC - 4%
TABLET;ORAL - 5MG
TABLET;ORAL - 7.5MG

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Seqens, 4 DKSH, 6 Gangwal Healthcare, 1 Pfanstiehl, 1 ACG Worldwide, 9 Actylis, 1 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 2 Finar, 7 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 18 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 5 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 12 Roquette, 6 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 The Dow Chemical Company, 1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

52 Coating Systems & Additives, 28 Controlled & Modified Release, 22 Fillers, Diluents & Binders, 18 Thickeners and Stabilizers, 17 Direct Compression, 11 Granulation, 10 Film Formers & Plasticizers, 10 Co-Processed Excipients, 10 Topical, 8 Parenteral, 8 Lubricants & Glidants, 7 Disintegrants & Superdisintegrants, 7 Solubilizers, 5 Empty Capsules, 5 API Stability Enhancers, 5 Taste Masking, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Chewable & Orodispersible Aids, 3 Emulsifying Agents, 2 Rheology Modifiers

DIGITAL CONTENT

25 NEWS #PharmaBuzz

media
25 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 21 Finished Drug Prices

globalSalesInformation
3 US Medicaid Prescriptions
21 Finished Drug Prices

MARKET PLACE

23 APIs, 2 FDF Dossiers

marketPlace
23 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

10 US Patents, 3 US Exclusivities

patents
10 US Patents
3 US Exclusivities

REF. STANDARDS & IMPURITIES

2 EDQM , 2 USP , 2 Others

otherSolutions
2 EDQM
2 USP
2 Others

LGM Pilocarpine Hydrochloride

Synopsis

ACTIVE PHARMA INGREDIENTS

16

API Suppliers

8

USDMF

3

CEP/COS

CEP/COS Certifications

1

JDMF

0

EU WC

1

KDMF

8

NDC API

0

VMF

8

Listed Suppliers

API REF. PRICE (USD/KG)

$

$ 6,941

MARKET PLACE

23

API

2

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

70

FDF Dossiers

29

FDA Orange Book

FDA (Orange Book)

23

Europe

4

Canada

9

Australia

4

South Africa

1

Listed Dossiers

26DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

2

EDQM

2

USP

0

JP

2

Others

PATENTS & EXCLUSIVITIES

10

US Patents

3

US Exclusivities

0

Health Canada Patents

DIGITAL CONTENT

0

Data Compilation #PharmaFlow

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

25

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

494,518

Annual Reports (USD Million)

NA

Finished Drug Prices

142 RELATED EXCIPIENT COMPANIES

239EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 54-71-7, (+)-pilocarpine hydrochloride, Pilocarpine hcl, Almocarpine, Salagen, Adsorbocarpine

Molecular Formula

C₁₁H₁₇ClN₂O₂

Molecular Weight

244.72 g/mol

InChI Key

RNAICSBVACLLGM-GNAZCLTHSA-N

FDA UNII

0WW6D218XJ

Pilocarpine Hydrochloride

A slowly hydrolyzed muscarinic agonist with no nicotinic effects. Pilocarpine is used as a miotic and in the treatment of glaucoma.

1 2D Structure

Pilocarpine Hydrochloride

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(3S,4R)-3-ethyl-4-[(3-methylimidazol-4-yl)methyl]oxolan-2-one;hydrochloride

2.1.2 InChI

InChI=1S/C11H16N2O2.ClH/c1-3-10-8(6-15-11(10)14)4-9-5-12-7-13(9)2;/h5,7-8,10H,3-4,6H2,1-2H3;1H/t8-,10-;/m0./s1

2.1.3 InChI Key

RNAICSBVACLLGM-GNAZCLTHSA-N

2.1.4 Canonical SMILES

CCC1C(COC1=O)CC2=CN=CN2C.Cl

2.1.5 Isomeric SMILES

CC[C@H]1[C@H](COC1=O)CC2=CN=CN2C.Cl

2.2 Other Identifiers

2.2.1 UNII

0WW6D218XJ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. Hydrochloride, Pilocarpine

2. Isopilocarpine

3. Isoptocarpine

4. Nitrate, Pilocarpine

5. Ocusert

6. Pilocarpine

7. Pilocarpine Mononitrate, (3s-cis)-isomer

8. Pilocarpine Nitrate

9. Pilocarpine, Monohydrochloride, (3s-cis)-isomer

10. Salagen

2.3.2 Depositor-Supplied Synonyms

1. 54-71-7

2. (+)-pilocarpine Hydrochloride

3. Pilocarpine Hcl

4. Almocarpine

5. Salagen

6. Adsorbocarpine

7. Pilocarpal

8. Pilocar

9. Pilocar Smp

10. Pilocarpine Monohydrochloride

11. Pilomiotin

12. Pilovisc

13. Pilocel

14. Sno Pilo

15. Mistura P

16. Pilocarpine Muriate

17. Epicar

18. Mi-pilo Ophth Sol

19. Pilopine Hs

20. Vistacarpin N

21. Pilocarpine, Hydrochloride

22. Spersacarpine Hydrochloride

23. Pilokarpin Monohydrochloride

24. Pilopine

25. Pilocarpine Chloride

26. Pilocarpine (hydrochloride)

27. Pilo

28. Pilocarpinum Muriaticum

29. Pilocarpine, Monohydrochloride

30. Pilocarpine Hydrochlororide

31. Mls000069454

32. 0ww6d218xj

33. Isoptocarpine

34. (3s,4r)-3-ethyl-4-[(3-methylimidazol-4-yl)methyl]oxolan-2-one;hydrochloride

35. Nsc5746

36. Smr000059053

37. Isopto Carpine

38. Isopto-carpine

39. Ami-pilo

40. Amistura P

41. 2(3h)-furanone, 3-ethyldihydro-4-((1-methyl-1h-imidazol-5-yl)methyl)-, Monohydrochloride, (3s,4r)-

42. 2(3h)-furanone, 3-ethyldihydro-4-((1-methyl-1h-imidazol-5-yl)methyl)-, Monohydrochloride, (3s-cis)-

43. Pilopine Hs Gel

44. Nsc 5746

45. (3s,4r)-3-ethyl-4-((1-methyl-1h-imidazol-5-yl)methyl)dihydrofuran-2(3h)-one Hydrochloride

46. (3s,4r)-3-ethyl-4-[(1-methyl-1h-imidazol-5-yl)methyl]dihydrofuran-2(3h)-one Hydrochloride

47. Einecs 200-212-5

48. Unii-0ww6d218xj

49. Pilocarpine-hcl

50. Ai3-61859

51. Sr-01000000054

52. Mi-pilo

53. Component Of Epicar

54. Salagen (tn)

55. Sanpilo (tn)

56. Component Of Pilocar

57. Pilocarpine Hydrochloride [usp:jan]

58. Vuity

59. Pilopine Hs (tn)

60. Isopto Carpine (tn)

61. Nsc-5746

62. Pilocarpini Hydrochloridum

63. Regid855931

64. Opera_id_1616

65. Schembl41427

66. Mls000758210

67. Mls001076314

68. Mls001424017

69. Nsc 5746 Hcl

70. Pilocarpine Hcl [vandf]

71. Chembl1200330

72. Dtxsid2041096

73. Chebi:141029

74. Hy-b0726

75. Tox21_500950

76. S4231

77. Pilocarpine Hydrochloride [mi]

78. Pilocarpinum Muriaticum [hpus]

79. Akos005267231

80. Pilocarpine Hydrochloride (jp17/usp)

81. Ccg-100757

82. Lp00950

83. Nc00007

84. Pilocarpine Hydrochloride [jan]

85. (3s,4r)-3-ethyl-4-[(1-methylimidazol-5-yl)methyl]-3,4,5-trihydrofuran-2-one, C Hloride

86. Ncgc00094254-01

87. Ncgc00261635-01

88. Pilocarpine Hydrochloride [mart.]

89. Pilocarpine Hydrochloride [vandf]

90. Ac-33119

91. Pilocarpine Hydrochloride [usp-rs]

92. Pilocarpine Hydrochloride [who-dd]

93. Pilocarpine Hydrochloride [who-ip]

94. Eu-0100950

95. Sw196587-4

96. D02200

97. D91961

98. P 6503

99. Pilocarpine Hydrochloride [ep Impurity]

100. Pilocarpine Hydrochloride [ep Monograph]

101. Pilocarpine Hydrochloride [orange Book]

102. Pilocarpine Hydrochloride [usp Impurity]

103. 2(3h)-furanone, Monohydrochloride, (3s-cis)-

104. Pilocarpine Hydrochloride [usp Monograph]

105. Pilocarpini Hydrochloridum [who-ip Latin]

106. Wln: T5ovtj C2 D1- Dt5n Cnj C1 &gh

107. Sr-01000000054-3

108. Sr-01000075339-1

109. Pilocarpine Hydrochloride, >=98% (titration), Powder

110. Q23059847

111. Betoptic Pilo Component Pilocarpine Hydrochloride

112. Pilocarpine Hydrochloride Component Of Betoptic Pilo

113. Pilocarpine Hydrochloride, Meets Usp Testing Specifications

114. Pilocarpine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

115. (3s,4r)-3-ethyl-4-[(1-methyl-1h-imidazol-5-yl)methyl]oxolan-2-one Hydrochloride

116. Pilocarpine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

117. Pilocarpine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

118. (3s-cis)-3-ethyldihydro-4-[(1-methyl-1h-imidazol-5-yl)methyl]-2(3h)-furanone Hydrochloride

119. 2(3h)-furanone, 3-ethyldihydro-4-((1-methyl-1h-imidazol-5-yl)methyl)-, Hydrochloride (1:1), (3s,4r)-

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₁₁H₁₇ClN₂O₂
Molecular Weight	244.72 g/mol
Hydrogen Bond Donor Count	1
Hydrogen Bond Acceptor Count	3
Rotatable Bond Count	3
Exact Mass	244.0978555 g/mol
Monoisotopic Mass	244.0978555 g/mol
Topological Polar Surface Area	44.1 Å²
Heavy Atom Count	16
Formal Charge	0
Complexity	245
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 8
Drug Name	Isopto carpine
PubMed Health	Pilocarpine
Drug Classes	Dental Agent, Direct Acting Miotic
Drug Label	Isopto Carpine (pilocarpine hydrochloride ophthalmic solution) is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:Established name: pilocarpine hydrochlorideChe...
Active Ingredient	Pilocarpine hydrochloride
Dosage Form	Solution
Route	Ophthalmic
Strength	1%; 2%; 4%
Market Status	Prescription
Company	Alcon Res

2 of 8
Drug Name	Pilocarpine hydrochloride
PubMed Health	Pilocarpine
Drug Classes	Dental Agent, Direct Acting Miotic
Drug Label	Pilocarpine hydrochloride tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder, which is soluble in water and alcohol and virtually...
Active Ingredient	Pilocarpine hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	7.5mg; 5mg
Market Status	Prescription
Company	Corepharma; Roxane; Lannett; Impax Labs

3 of 8
Drug Name	Pilopine hs
Drug Label	SALAGEN Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in mos...
Active Ingredient	Pilocarpine hydrochloride
Dosage Form	Gel
Route	Ophthalmic
Strength	4%
Market Status	Prescription
Company	Alcon

4 of 8
Drug Name	Salagen
Active Ingredient	Pilocarpine hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	7.5mg; 5mg
Market Status	Prescription
Company	Eisai

5 of 8
Drug Name	Isopto carpine
PubMed Health	Pilocarpine
Drug Classes	Dental Agent, Direct Acting Miotic
Drug Label	Isopto Carpine (pilocarpine hydrochloride ophthalmic solution) is a cholinergic agonist prepared as a sterile topical ophthalmic solution. The active ingredient is represented by the chemical structure:Established name: pilocarpine hydrochlorideChe...
Active Ingredient	Pilocarpine hydrochloride
Dosage Form	Solution
Route	Ophthalmic
Strength	1%; 2%; 4%
Market Status	Prescription
Company	Alcon Res

6 of 8
Drug Name	Pilocarpine hydrochloride
PubMed Health	Pilocarpine
Drug Classes	Dental Agent, Direct Acting Miotic
Drug Label	Pilocarpine hydrochloride tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder, which is soluble in water and alcohol and virtually...
Active Ingredient	Pilocarpine hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	7.5mg; 5mg
Market Status	Prescription
Company	Corepharma; Roxane; Lannett; Impax Labs

7 of 8
Drug Name	Pilopine hs
Drug Label	SALAGEN Tablets contain pilocarpine hydrochloride, a cholinergic agonist for oral use. Pilocarpine hydrochloride is a hygroscopic, odorless, bitter tasting white crystal or powder which is soluble in water and alcohol and virtually insoluble in mos...
Active Ingredient	Pilocarpine hydrochloride
Dosage Form	Gel
Route	Ophthalmic
Strength	4%
Market Status	Prescription
Company	Alcon

8 of 8
Drug Name	Salagen
Active Ingredient	Pilocarpine hydrochloride
Dosage Form	Tablet
Route	Oral
Strength	7.5mg; 5mg
Market Status	Prescription
Company	Eisai

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Muscarinic Agonists

Drugs that bind to and activate muscarinic cholinergic receptors (RECEPTORS, MUSCARINIC). Muscarinic agonists are most commonly used when it is desirable to increase smooth muscle tone, especially in the GI tract, urinary bladder and the eye. They may also be used to reduce heart rate. (See all compounds classified as Muscarinic Agonists.)

Miotics

Agents causing contraction of the pupil of the eye. Some sources use the term miotics only for the parasympathomimetics but any drug used to induce miosis is included here. (See all compounds classified as Miotics.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Cholinergic Muscarinic Agonists [MoA]; Cholinergic Receptor Agonist [EPC]; Cholinergic Agonists [MoA]

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API Reference Price

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LIMITED","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"10000","totalValueFC":"10122.7","currency":"USD","unitRateINR":"843769.9","date":"04-May-2024","totalValueINR":"843769.92","totalValueInUsd":"10122.7","indian_port":"Bombay Air","hs_no":"29397900","bill_no":"3336287","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG - FUHLSBUETT","supplierAddress":"GRUNER DEICH 1-3 20097 HAMBURG MFG:SOURTECH QUIMICA LTDA,BRAZILSDNF Germany","customerAddress":"98, GOVT.INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717353000,"product":"PILOCARPINE HYDROCHLORIDE USP MILLED","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"VIVATIS","supplierCountry":"GERMANY","foreign_port":"HAMBURG","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"8900","totalValueFC":"89928.1","currency":"USD","unitRateINR":"750715","date":"03-Jun-2024","totalValueINR":"7507150","totalValueInUsd":"89928.1","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29397200","bill_no":"1002043","productDescription":"API","marketType":"REGULATED MARKET","country":"GERMANY","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG","supplierAddress":"GRUNER DEICH 1-3 20097 HAMBURG GERMANY","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720117800,"product":"PILOCARPINE HYDROCHLORIDE PH.EUR (A69905)","address":"251-254,IIND FLOOR, DLF TOWER","city":"NEW DELHI","supplier":"C-SQUARED PHARMA","supplierCountry":"BRAZIL","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"GRACURE PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"4.00","actualQuantity":"4","unit":"KGS","unitRateFc":"7300","totalValueFC":"29500","currency":"USD","unitRateINR":"616485","date":"05-Jul-2024","totalValueINR":"2465940","totalValueInUsd":"29500","indian_port":"Delhi Air","hs_no":"29397900","bill_no":"4343637","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2 SKEHARD ROADT12 H2TK CORK IRELANDIRELAND IRELAND SDNF","customerAddress":"251-254,IIND FLOOR, DLF TOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1723228200,"product":"PILOCARPINE HYDROCHLORIDE USP","address":"98, GOVT.INDUSTRIAL AREA,","city":"MUMBAI.","supplier":"VIVATIS","supplierCountry":"BRAZIL","foreign_port":"HAMBURG - FUHLSBUETT","customer":"AJANTA PHARMA LIMITED","customerCountry":"INDIA","quantity":"2.00","actualQuantity":"2","unit":"KGS","unitRateFc":"9500","totalValueFC":"19169.6","currency":"USD","unitRateINR":"803957.2","date":"10-Aug-2024","totalValueINR":"1607914.37","totalValueInUsd":"19169.6","indian_port":"Bombay Air","hs_no":"29397900","bill_no":"4988193","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG - FUHLSBUETT","supplierAddress":"GRUNER DEICH 1-3 20097 HAMBURG MFG:SOURTECH QUIMICA LTDA,BRAZILSDNF Germany","customerAddress":"98, GOVT.INDUSTRIAL AREA,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725301800,"product":"PILOCARPINE HYDROCHLORIDE MILLED PILOCARPINE HYDROCHLORIDE MILLED","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"VIVATIS","supplierCountry":"BRAZIL","foreign_port":"HAMBURG","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"8900","totalValueFC":"135170.8","currency":"USD","unitRateINR":"755165","date":"03-Sep-2024","totalValueINR":"11327475","totalValueInUsd":"135170.8","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29397900","bill_no":"5402148","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"HAMBURG","supplierAddress":"GRUNER DEICH 1-3 HAMBURG 290097 DE","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726857000,"product":"(FOC) - PILOCARPINE HYDROCHLORIDE - A69905 - VC-2205","address":"REGD. OFFICE: NO. 16\/2,","city":"BANGALORE, KARNATAKA","supplier":"C-SQUARED PHARMA","supplierCountry":"BRAZIL","foreign_port":"FRANKFURT\/MAIN INT\\'L","customer":"SOMERSET THERAPEUTICS PRIVATE LIMITED","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"6978","totalValueFC":"359134.9","currency":"USD","unitRateINR":"601918.8","date":"21-Sep-2024","totalValueINR":"30095942.4","totalValueInUsd":"359134.9","indian_port":"Bangalore Air","hs_no":"29397900","bill_no":"5732357","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"BRAZIL","selfForZScoreResived":"Pharma Grade","supplierPort":"FRANKFURT\/MAIN INT\\'L","supplierAddress":"BRIDGE HOUSE UNIT 2 SHEHARD ROAD T1 2 H2TK CORK IRELAND (IRL) Dublin, , Ireland Ireland","customerAddress":"REGD. OFFICE: NO. 16\/2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729276200,"product":"PILOCARPINE HYDROCHLORIDE PILOCARPINE HYDROCHLORIDE","address":"882\/1-871, NEAR KANKAVATI ,VILLAGE-","city":"AHMEDABAD, GUJARAT","supplier":"C-SQUARED PHARMA","supplierCountry":"IRELAND","foreign_port":"BASEL","customer":"AMNEAL PHARMACEUTICALS","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"6855","totalValueFC":"69303.4","currency":"USD","unitRateINR":"582332.3","date":"19-Oct-2024","totalValueINR":"5823322.5","totalValueInUsd":"69303.4","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29397900","bill_no":"6209025","productDescription":"API","marketType":"REGULATED MARKET","country":"IRELAND","selfForZScoreResived":"Pharma Grade","supplierPort":"BASEL","supplierAddress":"BRIDGE HOUSE UNIT 2 SKEHARD ROAD T12 H2TK CORK SDNF IE","customerAddress":"882\/1-871, NEAR KANKAVATI ,VILLAGE-"}]

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

01

AbbVie Inc

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

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Lead Product(s) : Pilocarpine Hydrochloride

Therapeutic Area : Ophthalmology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Allergan, an AbbVie Company, Announces Positive Topline Phase 3 Results Evaluating Investigational...

Details : In the VIRGO trial evaluating twice-daily administration of VUITY (pilocarpine HCl ophthalmic solution), the primary endpoint of improving near vision without compromising distance vision at Day 14, Hour 9 was met.

Brand Name : Vuity

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 05, 2022

Abbvie Company Banner

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02

AbbVie Inc

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

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Lead Product(s) : Pilocarpine Hydrochloride

Therapeutic Area : Ophthalmology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

VUITY™ (Pilocarpine HCI Ophthalmic Solution) 1.25%, the First and Only FDA-Approved Eye Drop to ...

Details : FDA approval of VUITY (Pilocarpine), is a once-daily prescription eye drop that improves near and intermediate vision without impacting distance vision for adults with age-related blurry near vision.

Brand Name : Vuity

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 09, 2021

Abbvie Company Banner

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03

Allergan Aesthetics

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

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Lead Product(s) : Pilocarpine Hydrochloride

Therapeutic Area : Ophthalmology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Allergan, an AbbVie Company, to Present New Data from its Leading Portfolio of Eye Care Treatments...

Details : VUITY, an optimized formulation of pilocarpine, established eye care therapeutic, specifically designed to treat age-related blurry near vision. It is delivered with proprietary pHast™ technology, which allows VUITY to rapidly adjust to physiologic pH ...

Brand Name : Vuity

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 28, 2022

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04

Allergan Aesthetics

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

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Lead Product(s) : Pilocarpine Hydrochloride

Therapeutic Area : Ophthalmology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Allergan, an AbbVie Company, to Present New Data from its Eye Care Portfolio at the 2022 American ...

Details : VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, specifically designed to treat age-related blurry near vision. It is delivered with proprietary pHas technology, which allows VUITY to rapidly adjust to physiologic pH...

Brand Name : Vuity

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 19, 2022

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05

Allergan Aesthetics

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

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Lead Product(s) : Pilocarpine Hydrochloride

Therapeutic Area : Ophthalmology

Highest Development Status : Approved

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

U.S. Food and Drug Administration Approves VUITY™ (Pilocarpine HCI Ophthalmic Solution) 1.25%, t...

Details : VUITY™ (pilocarpine HCL ophthalmic solution) 1.25% is a prescription eyedrop to treat age-related blurry near vision (presbyopia) in adults. VUITY to improve near and intermediate vision without impacting distance vision with one drop daily.

Brand Name : Vuity

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 29, 2021

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06

Allergan Aesthetics

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

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Lead Product(s) : Pilocarpine Hydrochloride

Therapeutic Area : Ophthalmology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : AbbVie Inc

Deal Size : Not Applicable

Deal Type : Not Applicable

Allergan to Share New Data Highlighting Latest Advancements in Eye Care at ARVO 2021 Annual Virtua...

Details : The company will present patient-reported outcomes for AGN-190584, an investigational therapy for the treatment of presbyopia. Recently the company submitted an NDA to the U.S. Food and Drug Administration based on data from the Phase 3 GEMINI 1 and GEMI...

Brand Name : AGN-190584

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 27, 2021

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07

Allergan Aesthetics

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

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Lead Product(s) : Pilocarpine Hydrochloride

Therapeutic Area : Ophthalmology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : AbbVie Inc

Deal Size : Not Applicable

Deal Type : Not Applicable

Allergan, an AbbVie Company, Submits New Drug Application for Investigational AGN-190584 for the T...

Details : Allergan has submitted a New Drug Application to the U.S. Food and Drug Administration for investigational AGN-190584 (pilocarpine 1.25%) ophthalmic solution for the treatment of presbyopia. The FDA is expected to act on the NDA by the end of 2021.

Brand Name : AGN-190584

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 25, 2021

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08

Allergan Aesthetics

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

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Lead Product(s) : Pilocarpine Hydrochloride

Therapeutic Area : Ophthalmology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : Not Applicable

Deal Size : Not Applicable

Deal Type : Not Applicable

Allergan, an AbbVie Company, to Share New Data at American Academy of Ophthalmology (AAO) 2020 Vir...

Details : Data presented at the meeting will include an analysis examining the safety and efficacy of DURYSTA™ and a second analysis of data from the Phase 3 ARTEMIS studies that identify different characteristics of glaucoma patients who may respond after being...

Brand Name : AGN-190584

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 06, 2020

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09

Allergan Aesthetics

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

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Lead Product(s) : Pilocarpine Hydrochloride

Therapeutic Area : Ophthalmology

Highest Development Status : Phase III

Partner/Sponsor/Collaborator : AbbVie Inc

Deal Size : Not Applicable

Deal Type : Not Applicable

Allergan, an AbbVie Company, Announces Positive Phase 3 Topline Results for Investigational AGN-19...

Details : Phase 3 GEMINI 1 and 2 studies evaluating AGN-190584 (pilocarpine 1.25%) ophthalmic solution met the primary endpoint, reaching statistical significance in improvement in near vision.

Brand Name : AGN-190584

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 28, 2020

Stock Recap
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10

Orasis Pharmaceuticals

Israel

Pharma, Lab & Chemical Expo

Not Confirmed

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Canada

01

AMDIPHARM LIMITED

United Kingdom

BIO Partnering at JPM

Not Confirmed

02

JAMP PHARMA CORPORATION

Canada

BIO Partnering at JPM

Not Confirmed

03

MANTRA PHARMA INC

Canada

BIO Partnering at JPM

Not Confirmed

04

NOVARTIS PHARMACEUTICALS CANADA INC

Switzerland

BIO Partnering at JPM

Not Confirmed

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SOLUTION;OPHTHALMIC - 1%

USFDA APPLICATION NUMBER - 200890

DOSAGE - SOLUTION;OPHTHALMIC - 2%

USFDA APPLICATION NUMBER - 200890

DOSAGE - SOLUTION;OPHTHALMIC - 4%

USFDA APPLICATION NUMBER - 200890

DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 20237

DOSAGE - TABLET;ORAL - 7.5MG

USFDA APPLICATION NUMBER - 20237

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ABOUT THIS PAGE

Pilocarpine Hydrochloride Manufacturers

A Pilocarpine Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pilocarpine Hydrochloride, including repackagers and relabelers. The FDA regulates Pilocarpine Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pilocarpine Hydrochloride API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Pilocarpine Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Pilocarpine Hydrochloride Suppliers

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

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

Pilocarpine Hydrochloride USDMF

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

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

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

Pilocarpine Hydrochloride JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Pilocarpine Hydrochloride Drug Master File in Japan (Pilocarpine Hydrochloride JDMF) empowers Pilocarpine Hydrochloride API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Pilocarpine Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Pilocarpine Hydrochloride JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Pilocarpine Hydrochloride suppliers with JDMF on PharmaCompass.

Pilocarpine Hydrochloride KDMF

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

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

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

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

Pilocarpine Hydrochloride CEP

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

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

Pilocarpine Hydrochloride NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pilocarpine Hydrochloride as an active pharmaceutical ingredient (API).

Finished drug products

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

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Pilocarpine Hydrochloride as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

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

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

Pilocarpine Hydrochloride GMP

Pilocarpine Hydrochloride Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Pilocarpine Hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Pilocarpine Hydrochloride GMP manufacturer or Pilocarpine Hydrochloride GMP API supplier for your needs.

Pilocarpine Hydrochloride CoA

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

Pilocarpine Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Pilocarpine Hydrochloride CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

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

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

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