Gemcitabine Hydrochloride | NDC API | APIs

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ACTIVE PHARMA INGREDIENTS

76 API Suppliers, 31 USDMF, 25 CEP/COS, 13 JDMF, 13 EU WC, 31 KDMF, 18 NDC API, 41 Listed Suppliers, $ API Reference Price

76 API Suppliers
31 USDMF
25 CEP/COS
13 JDMF
13 EU WC
31 KDMF
18 NDC API
41 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

250 Drugs in Development

250 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

245 FDF Dossiers, 88 FDA Orange Book, 89 Europe, 4 Canada, 4 Australia, 21 South Africa, 39 Listed Dossiers

245 FDF Dossiers
88 FDA Orange Book
89 Europe
4 Canada
4 Australia
21 South Africa
39 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML), SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

drugProductComposition
INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)
SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 12 SPI Pharma, 1 Pfanstiehl, 1 Actylis, 1 BASF, 2 Gangwal Chemicals, 1 Ingredion Pharma Solutions, 2 Kerry, 2 Microlex e.U, 1 Pluviaendo, 3 Roquette, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Sigachi Industries

relatedExcipients
1 Rochem International Inc
12 SPI Pharma
1 Pfanstiehl
1 Actylis
1 BASF
2 Gangwal Chemicals
1 Ingredion Pharma Solutions
2 Kerry
2 Microlex e.U
1 Pluviaendo
3 Roquette
1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
1 Sigachi Industries

EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders, 10 Chewable & Orodispersible Aids, 9 Taste Masking, 9 Direct Compression, 5 Parenteral, 3 Co-Processed Excipients, 3 Granulation, 3 Disintegrants & Superdisintegrants, 1 Thickeners and Stabilizers, 1 API Stability Enhancers

excipientsByApplications
17 Fillers, Diluents & Binders
10 Chewable & Orodispersible Aids
9 Taste Masking
9 Direct Compression
5 Parenteral
3 Co-Processed Excipients
3 Granulation
3 Disintegrants & Superdisintegrants
1 Thickeners and Stabilizers
1 API Stability Enhancers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 100 NEWS #PharmaBuzz

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3 DATA COMPILATION #PharmaFlow
100 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 69 Finished Drug Prices, 1 Annual Reports

globalSalesInformation
2 US Medicaid Prescriptions
69 Finished Drug Prices
1 Annual Reports

MARKET PLACE

15 APIs, 9 FDF Dossiers, 2 Intermediates

marketPlace
15 APIs
9 FDF Dossiers
2 Intermediates

PATENTS & EXCLUSIVITIES

10 US Patents

patents
10 US Patents

REF. STANDARDS & IMPURITIES

3 EDQM , 1 USP , 3 Others

otherSolutions
3 EDQM
1 USP
3 Others

DRL Gemcitabine

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 4,670

MARKET PLACE

API

FDF

19INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

245

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

250DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

100

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

533,371

Annual Reports (USD Million)

111

Finished Drug Prices

30 RELATED EXCIPIENT COMPANIES

61EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: Gemcitabine hcl, 122111-03-9, Gemzar, Ly188011 hydrochloride, Gemcitabine (hydrochloride), 2'-deoxy-2',2'-difluorocytidine monohydrochloride

Molecular Formula

C₉H₁₂ClF₂N₃O₄

Molecular Weight

299.66 g/mol

InChI Key

OKKDEIYWILRZIA-OSZBKLCCSA-N

FDA UNII

U347PV74IL

A deoxycytidine antimetabolite used as an antineoplastic agent.

1 2D Structure

Gemcitabine

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

4-amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one;hydrochloride

2.1.2 InChI

InChI=1S/C9H11F2N3O4.ClH/c10-9(11)6(16)4(3-15)18-7(9)14-2-1-5(12)13-8(14)17;/h1-2,4,6-7,15-16H,3H2,(H2,12,13,17);1H/t4-,6-,7-;/m1./s1

2.1.3 InChI Key

OKKDEIYWILRZIA-OSZBKLCCSA-N

2.1.4 Canonical SMILES

C1=CN(C(=O)N=C1N)C2C(C(C(O2)CO)O)(F)F.Cl

2.1.5 Isomeric SMILES

C1=CN(C(=O)N=C1N)[C@H]2C([C@@H]([C@H](O2)CO)O)(F)F.Cl

2.2 Other Identifiers

2.2.1 UNII

U347PV74IL

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 188011, Ly

2. 2' Deoxy 2' Difluorocytidine

3. 2' Deoxy 2',2'' Difluorocytidine 5' O Monophosphate

4. 2',2'-dfdc

5. 2',2'-difluoro-2'-deoxycytidine

6. 2',2'-difluorodeoxycytidine

7. 2'-deoxy-2',2''-difluorocytidine-5'-o-monophosphate

8. 2'-deoxy-2'-difluorocytidine

9. Dfdcyd

10. Gemcitabine

11. Gemcitabine, (alpha-d-threo-pentofuranosyl)-isomer

12. Gemcitabine, (beta-d-threo-pentafuranosyl)-isomer

13. Gemcitabine, (d-threo-pentafuranosyl)-isomer

14. Gemicitabine

15. Gemzar

16. Hydrochloride, Gemcitabine

17. Ly 188011

18. Ly-188011

2.3.2 Depositor-Supplied Synonyms

1. Gemcitabine Hcl

2. 122111-03-9

3. Gemzar

4. Ly188011 Hydrochloride

5. Gemcitabine (hydrochloride)

6. 2'-deoxy-2',2'-difluorocytidine Monohydrochloride

7. Cytidine, 2'-deoxy-2',2'-difluoro-, Monohydrochloride

8. Dfdc

9. 4-amino-1-((2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1h)-one Hydrochloride

10. Gemcitabine (as Hydrochloride)

11. U347pv74il

12. Chebi:31647

13. 2',2'-difluoro-2'-deoxycytidine Hydrochloride

14. Ly-188011 Hydrochloride

15. Ly-188011

16. 122111-03-9 (hcl)

17. Dsstox_cid_27827

18. Dsstox_rid_82590

19. Dsstox_gsid_47849

20. 2'-deoxy-2',2'-difluorocytidine Hydrochloride

21. 4-amino-1-[(2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl]pyrimidin-2-one;hydrochloride

22. Dizirconium Silicide

23. Cas-122111-03-9

24. Gemcitabine Hydrochloride [usan]

25. Gemcitabine Hcl (gemzar)

26. Ly 188011

27. Unii-u347pv74il

28. Mfcd01735988

29. Ncgc00168784-01

30. Gemzar (tn)

31. Infugem

32. Gemcitabine Hydrochloride [usan:usp]

33. Inno-d07001

34. Schembl4366

35. Chembl1637

36. Ly 188011 Hydrochloride

37. Mls003915643

38. Gemcitabine Hydrochloride,(s)

39. Dtxsid3047849

40. Ex-a837

41. 2'-deoxy-2',2'-difluorocytidine Monohydrochloride (beta-isomer)

42. Act06731

43. Hy-b0003

44. Ly-188011 . Hcl

45. Tox21_112644

46. Bdbm50247964

47. Gemcitabine Hydrochloride (jan/usp)

48. S1149

49. Gemcitabine Hydrochloride [mi]

50. Akos015999730

51. Tox21_112644_1

52. Ccg-267459

53. Cs-0755

54. Gemcitabine Hcl (gemzar,ly188011)

55. Gemcitabine Hydrochloride [jan]

56. 2'-deoxy-2',2'-difluorocytidine Hcl

57. Gemcitabine Hydrochloride [mart.]

58. Gemcitabine Hydrochloride [vandf]

59. Ncgc00168784-03

60. As-13656

61. Bg164501

62. Gemcitabine Hydrochloride [usp-rs]

63. Gemcitabine Hydrochloride [who-dd]

64. Smr000469146

65. Gemcitabine Hydrochloride, >=98% (hplc)

66. Gemcitabine Hydrochloride,gemzar, Ly-188011

67. D01155

68. Gemcitabine Hydrochloride [ep Monograph]

69. Gemcitabine Hydrochloride [orange Book]

70. 2'-deoxy-2',2'-difluorocytidine, Hydrochloride

71. Gemcitabine Hydrochloride [usp Monograph]

72. 111g039

73. W-60402

74. (+)-2'-deoxy-2',2'-difluorocytidine Hydrochloride

75. J-700175

76. Q27114559

77. 2'-deoxy-2',2'-difluorocytidine Monohydrochloride (.beta.-isomer)

78. Gemcitabine Hydrochloride, European Pharmacopoeia (ep) Reference Standard

79. Gemcitabine Hydrochloride, United States Pharmacopeia (usp) Reference Standard

80. (2'r,4'r,5'r)-4-amino-1-(3,3-difluoro-4-hydroxy-5-hydroxymethyl-tetrahydro-furan-2-yl)-1h-pyridin-2-one Hydrochloride

81. 4-amino-1-((2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)oxolan-2-yl)pyrimidin-2-one Hydrochloride

82. 4-amino-1-((2r,4r,5r)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl)tetrahydrofuran-2-yl)pyrimidin-2(1h)-onehydrochloride

2.3.3 Other Synonyms

1. Gemcitabine Free Base

2.4 Create Date

2005-06-24

3 Chemical and Physical Properties

Molecular Formula	C₉H₁₂ClF₂N₃O₄
Molecular Weight	299.66 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	6
Rotatable Bond Count	2
Exact Mass	299.0484399 g/mol
Monoisotopic Mass	299.0484399 g/mol
Topological Polar Surface Area	108 Å²
Heavy Atom Count	19
Formal Charge	0
Complexity	426
Isotope Atom Count	0
Defined Atom Stereocenter Count	3
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 4
Drug Name	Gemcitabine hydrochloride
Drug Label	Gemzar (gemcitabine for injection, USP) is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HCl is 2-deoxy-2,2-difluorocytidine monohydrochloride (-isomer). The structural formula is as follows: The empirical...
Active Ingredient	Gemcitabine hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	eq 2gm base/vial; eq 200mg base/vial; 1gm/26.3ml (38mg/ml); 2gm/52.6ml (38mg/ml); 200mg/5.26ml (38mg/ml); eq 1gm base/vial
Market Status	Prescription
Company	Hospira; Jiangsu Hansoh Pharm; Fresenius Kabi Oncol; Accord Hlthcare; Cipla; Sun Pharma Global; Actavis Elizabeth; Emcure Pharms; Teva Pharms; Fresenius Kabi Usa; Onco Therapies; Hameln Rds Gmbh; Luitpold; Sagent Pharms; Dr Reddys Labs

2 of 4
Drug Name	Gemzar
PubMed Health	Gemcitabine (Injection)
Drug Classes	Antineoplastic Agent
Drug Label	Gemzar (gemcitabine for injection, USP) is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HCl is 2-deoxy-2,2-difluorocytidine monohydrochloride (-isomer). The structural formula is as follows: The empirical...
Active Ingredient	Gemcitabine hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	eq 200mg base/vial; eq 1gm base/vial
Market Status	Prescription
Company	Lilly

3 of 4
Drug Name	Gemcitabine hydrochloride
Drug Label	Gemzar (gemcitabine for injection, USP) is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HCl is 2-deoxy-2,2-difluorocytidine monohydrochloride (-isomer). The structural formula is as follows: The empirical...
Active Ingredient	Gemcitabine hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	eq 2gm base/vial; eq 200mg base/vial; 1gm/26.3ml (38mg/ml); 2gm/52.6ml (38mg/ml); 200mg/5.26ml (38mg/ml); eq 1gm base/vial
Market Status	Prescription
Company	Hospira; Jiangsu Hansoh Pharm; Fresenius Kabi Oncol; Accord Hlthcare; Cipla; Sun Pharma Global; Actavis Elizabeth; Emcure Pharms; Teva Pharms; Fresenius Kabi Usa; Onco Therapies; Hameln Rds Gmbh; Luitpold; Sagent Pharms; Dr Reddys Labs

4 of 4
Drug Name	Gemzar
PubMed Health	Gemcitabine (Injection)
Drug Classes	Antineoplastic Agent
Drug Label	Gemzar (gemcitabine for injection, USP) is a nucleoside metabolic inhibitor that exhibits antitumor activity. Gemcitabine HCl is 2-deoxy-2,2-difluorocytidine monohydrochloride (-isomer). The structural formula is as follows: The empirical...
Active Ingredient	Gemcitabine hydrochloride
Dosage Form	Injectable
Route	Injection
Strength	eq 200mg base/vial; eq 1gm base/vial
Market Status	Prescription
Company	Lilly

4.2 Drug Indication

Treatment of urothelial carcinoma

5 Pharmacology and Biochemistry

5.1 MeSH Pharmacological Classification

Antimetabolites, Antineoplastic

Antimetabolites that are useful in cancer chemotherapy. (See all compounds classified as Antimetabolites, Antineoplastic.)

5.2 FDA Pharmacological Classification

5.2.1 Pharmacological Classes

Nucleoside Metabolic Inhibitor [EPC]; Nucleic Acid Synthesis Inhibitors [MoA]

API SUPPLIERS

01

Dr. Reddy's Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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LGM Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Booth #134

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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03

Chongqing Sintaho Pharmaceutical

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI Worldwide, Milan

Booth #3D118

Chongqing Sintaho Pharma: A trusted partner globally for chemosynthetic APIs.

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HRV Global Life Sciences

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Sigmak Lifesciences

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CPhI Worldwide, Milan

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Teva API

Israel

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Yangtze River Pharmaceutical Group

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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09

Archimica

Italy

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PharmaEssentia

China

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Dr Reddys Laboratories Ltd

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Gemcitabine Hydrochloride Usp

GDUFA

DMF Review : Complete

Rev. Date : 2016-06-27

Pay. Date : 2016-06-06

DMF Number : 18857

Submission : 2005-10-11

Status : Active

Type : II

02

Benzochem Lifesciences Pvt Ltd

India

26th North American ISSX

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03

Fresenius Kabi Oncology Ltd

Sweden

26th North American ISSX

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04

Jiangsu Hansoh Pharmaceutical Group ...

China

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05

Hetero Labs Ltd

India

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API Reference Price

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SOLA BRIDGE,,","city":"AHMEDABAD,GUJARAT","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"158.00","actualQuantity":"158","unit":"KGS","unitRateFc":"2800","totalValueFC":"441050.7","currency":"USD","unitRateINR":"215740","date":"06-May-2022","totalValueINR":"34086920","totalValueInUsd":"441050.7","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29420090","bill_no":"1001800","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"NO.1 NAN-KE 8TH ROAD, SOUTHERN TAIW AN SCIENCE PARK,SHAN-HUA, TAINAN 74 144 TAIWAN","customerAddress":"CORPORATE HOUSE, NR. SOLA BRIDGE,,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q3","strtotime":1661279400,"product":"(N.C.V) GEMCITABINE HYDROCHLORIDE POWDER (1BOTTLE =50G) (FORR&D UNIT ONLY)","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"INDIA","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"50","unit":"GMS","unitRateFc":"3.4","totalValueFC":"177.4","currency":"EUR","unitRateINR":"282.3","date":"24-Aug-2022","totalValueINR":"14116.05","totalValueInUsd":"177.4","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"2132816","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671042600,"product":"(N.C.V) GEMCITABINE HCL (JNJ-17000139-AAC) POWDER (1BOTTLE=10G) (FOR TESTING PURPOSE ONLY)","address":"L.B.S. MARG,,MULUND-WEST","city":"MUMBAI,MAHARASHTRA","supplier":"JOHNSON & JOHNSON","supplierCountry":"INDIA","foreign_port":"NA","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"10","unit":"GMS","unitRateFc":"3.3","totalValueFC":"74.4","currency":"EUR","unitRateINR":"612.9","date":"15-Dec-2022","totalValueINR":"6129.14","totalValueInUsd":"74.4","indian_port":"BOMBAY AIR","hs_no":"29334900","bill_no":"3752800","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"L.B.S. MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1688149800,"product":"GEMCITABINE HYDROCHLORIDE BATCH NO. 71627AA033","address":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ","city":"TAL- SANAND, DIST- AHMEDABAD","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"198.00","actualQuantity":"198","unit":"KGS","unitRateFc":"3278.2","totalValueFC":"655874.6","currency":"USD","unitRateINR":"272252.6","date":"01-Jul-2023","totalValueINR":"53906023","totalValueInUsd":"655874.6","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29420090","bill_no":"1002791","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"NO. 1, NAN-KE 8TH ROAD, SOUTHERN TAIWN SCIENCE PARK,","customerAddress":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1698777000,"product":"(71515) GEMCITABINE HCI USP (71515AA065)","address":"2ND FLOOR, CHINUBHAI CENTRE,","city":"AHMEDABAD, GUJARAT","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"INTAS PHARMACEUTICALS","customerCountry":"INDIA","quantity":"12.50","actualQuantity":"12.5","unit":"KGS","unitRateFc":"2600","totalValueFC":"32952.9","currency":"USD","unitRateINR":"218920","date":"01-Nov-2023","totalValueINR":"2736500","totalValueInUsd":"32952.9","indian_port":"Ahmedabad Air","hs_no":"29420090","bill_no":"8561025","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"NO. 01 NAN - KE ROAD SHAN-HUA TAINAN 74144 TAIWAN, , TaiwanSDNF Taiwan","customerAddress":"2ND FLOOR, CHINUBHAI CENTRE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1721673000,"product":"GEMCITABINE HYDROCHLORIDE PH.EUR","address":"H.NO. 8-2-337,BESIDE TV9 OFFICE","city":"HYDERABAD ANDHRA PRADESH","supplier":"DR. REDDY\\'S LABORATORIES S.A","supplierCountry":"AUSTRIA","foreign_port":"VIENNA","customer":"DR. REDDY\\\\\\'S LABORATORIES","customerCountry":"INDIA","quantity":"126.51","actualQuantity":"126.506","unit":"KGS","unitRateFc":"2562.1","totalValueFC":"333477.1","currency":"USD","unitRateINR":"218905.3","date":"23-Jul-2024","totalValueINR":"27692830.6","totalValueInUsd":"333477.1","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"4650704","productDescription":"API","marketType":"REGULATED MARKET","country":"AUSTRIA","selfForZScoreResived":"Pharma Grade","supplierPort":"VIENNA","supplierAddress":"ELISABETHENANLAGE 11 BASEL 4051 SWITZERLANDSDNF Switzerland","customerAddress":"H.NO. 8-2-337,BESIDE TV9 OFFICE"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722537000,"product":"GEMCITABINE HYDROCHLORIDE BATCH NO. 71801AA002","address":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ","city":"TAL- SANAND, DIST- AHMEDABAD","supplier":"SCINOPHARM TAIWAN, LTD","supplierCountry":"TAIWAN","foreign_port":"TAIPEI","customer":"ZYDUS LIFESCIENCES","customerCountry":"INDIA","quantity":"79.32","actualQuantity":"79.318","unit":"KGS","unitRateFc":"3258.8","totalValueFC":"263328.2","currency":"USD","unitRateINR":"275693.8","date":"02-Aug-2024","totalValueINR":"21867483.84","totalValueInUsd":"263328.2","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29335990","bill_no":"4837509","productDescription":"API","marketType":"REGULATED MARKET","country":"TAIWAN","selfForZScoreResived":"Pharma Grade","supplierPort":"TAIPEI","supplierAddress":"No. 1, Nan-Ke-8th road SHAN HUA Tainan SDNF Taiwan","customerAddress":"PLOT NO. 3, PHARMEZ, SEZ, SARKEHJ"}]

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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DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/V...DOSAGE - INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20509

DOSAGE - INJECTABLE;INJECTION - EQ 200MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 20509

DOSAGE - SOLUTION;INTRAVENOUS - EQ 1200MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)

USFDA APPLICATION NUMBER - 208313

DOSAGE - SOLUTION;INTRAVENOUS - EQ 1300MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)

USFDA APPLICATION NUMBER - 208313

DOSAGE - SOLUTION;INTRAVENOUS - EQ 1400MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)

USFDA APPLICATION NUMBER - 208313

DOSAGE - SOLUTION;INTRAVENOUS - EQ 1500MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)

USFDA APPLICATION NUMBER - 208313

DOSAGE - SOLUTION;INTRAVENOUS - EQ 1600MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)

USFDA APPLICATION NUMBER - 208313

DOSAGE - SOLUTION;INTRAVENOUS - EQ 1700MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)

USFDA APPLICATION NUMBER - 208313

DOSAGE - SOLUTION;INTRAVENOUS - EQ 1800MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)

USFDA APPLICATION NUMBER - 208313

DOSAGE - SOLUTION;INTRAVENOUS - EQ 1900MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)

USFDA APPLICATION NUMBER - 208313

DOSAGE - SOLUTION;INTRAVENOUS - EQ 2000MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)

USFDA APPLICATION NUMBER - 208313

DOSAGE - SOLUTION;INTRAVENOUS - EQ 2200MG BAS...DOSAGE - SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

USFDA APPLICATION NUMBER - 208313

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ABOUT THIS PAGE

Gemcitabine Hydrochloride Manufacturers | Traders | Suppliers

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List of NDC API details of Gemcitabine Hydrochloride Active Pharmaceutical Ingredient listed on PharmaCompass.com

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

76 API Suppliers

31 USDMF

25 CEP/COS

13 JDMF

13 EU WC

31 KDMF

18 NDC API

41 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

250 Drugs in Development

INTERMEDIATES

19 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

245 FDF Dossiers

88 FDA Orange Book

89 Europe

4 Canada

4 Australia

21 South Africa

39 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

SOLUTION;INTRAVENOUS - EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)

SOLUTION;INTRAVENOUS - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)

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EXCIPIENTS BY APPLICATIONS

17 Fillers, Diluents & Binders

10 Chewable & Orodispersible Aids

9 Taste Masking

9 Direct Compression

5 Parenteral

3 Co-Processed Excipients

3 Granulation

3 Disintegrants & Superdisintegrants

1 Thickeners and Stabilizers

1 API Stability Enhancers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow

100 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions

69 Finished Drug Prices

1 Annual Reports

MARKET PLACE

15 APIs

9 FDF Dossiers

2 Intermediates

PATENTS & EXCLUSIVITIES

10 US Patents

REF. STANDARDS & IMPURITIES

INJECTABLE;INJECTION - EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INJECTION - EQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons