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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

Gemcitabine
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 Weight 299.66 g/mol
Molecular Formula C9H12ClF2N3O4
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count6
Rotatable Bond Count2
Exact Mass299.0484399 g/mol
Monoisotopic Mass299.0484399 g/mol
Topological Polar Surface Area108 Ų
Heavy Atom Count19
Formal Charge0
Complexity426
Isotope Atom Count0
Defined Atom Stereocenter Count3
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameGemcitabine hydrochloride
Drug LabelGemzar (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 IngredientGemcitabine hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 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 StatusPrescription
CompanyHospira; 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 NameGemzar
PubMed HealthGemcitabine (Injection)
Drug ClassesAntineoplastic Agent
Drug LabelGemzar (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 IngredientGemcitabine hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 200mg base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyLilly

3 of 4  
Drug NameGemcitabine hydrochloride
Drug LabelGemzar (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 IngredientGemcitabine hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 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 StatusPrescription
CompanyHospira; 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 NameGemzar
PubMed HealthGemcitabine (Injection)
Drug ClassesAntineoplastic Agent
Drug LabelGemzar (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 IngredientGemcitabine hydrochloride
Dosage FormInjectable
RouteInjection
Strengtheq 200mg base/vial; eq 1gm base/vial
Market StatusPrescription
CompanyLilly

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]

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NFG.KG,","supplierCountry":"INDIA","foreign_port":"SALZBURG","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"96.90","actualQuantity":"96.899","unit":"KGS","unitRateFc":"2251","totalValueFC":"220753.1","currency":"USD","unitRateINR":"191427.4","date":"14-Oct-2024","totalValueINR":"18549119.51","totalValueInUsd":"220753.1","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"6096574","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"SALZBURG","supplierAddress":"MONDSEESTRABE 11, 4866 UNTERACH SDNF AT","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"GEMCITABINE HYDROCHLORIDE BATCH NO.71801AA028","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":"70.87","actualQuantity":"70.87","unit":"KGS","unitRateFc":"3263.3","totalValueFC":"233813.3","currency":"USD","unitRateINR":"277219.2","date":"21-Oct-2024","totalValueINR":"19646523.91","totalValueInUsd":"233813.3","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29335990","bill_no":"6235685","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"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729449000,"product":"GEMCITABINE HYDROCHLORIDE BATCH NO.71801AA029","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":"21.45","actualQuantity":"21.448","unit":"KGS","unitRateFc":"3263.3","totalValueFC":"70760.9","currency":"USD","unitRateINR":"277219.2","date":"21-Oct-2024","totalValueINR":"5945797.16","totalValueInUsd":"70760.9","indian_port":"Ahmedabad-ZIPL-SEZ","hs_no":"29335990","bill_no":"6235685","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"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"(N.C.V.) JNJ-17000139-AAC,R139810 GEMCITABINE-HYDROCHLORIDE(REFERENCE STANDARD) CYTIDINE,2\\'-DEOXY-2\\',2\\'-DIFLUORO-,HYDR","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"JOHNSON & JOHNSON","supplierCountry":"INDIA","foreign_port":"BRUSSELS","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"4","unit":"GMS","unitRateFc":"296.4","totalValueFC":"1275.8","currency":"EUR","unitRateINR":"26915.8","date":"25-Nov-2024","totalValueINR":"107663.38","totalValueInUsd":"1275.8","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"6868673","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG 30 B-2340 Beerse, , B elgium SDNF Belgium","customerAddress":"30 FORJETT STREET"}]
05-Jan-2021
05-Feb-2025
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

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API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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FDA Orange Book

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01

ACCORD HLTHCARE

United Kingdom
MAGHREB PHARMA
Not Confirmed
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ACCORD HLTHCARE

United Kingdom
arrow
MAGHREB PHARMA
Not Confirmed

GEMCITABINE HYDROCHLORIDE

Brand Name : GEMCITABINE HYDROCHLORIDE

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 1.5GM/15ML (100MG/ML)

Approval Date : 2017-08-03

Application Number : 209604

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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02

APOTEX

Canada
MAGHREB PHARMA
Not Confirmed
arrow

APOTEX

Canada
arrow
MAGHREB PHARMA
Not Confirmed

GEMCITABINE HYDROCHLORIDE

Brand Name : GEMCITABINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1GM/26.3ML (38MG/ML)

Approval Date : 2017-05-23

Application Number : 206776

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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03

MAGHREB PHARMA
Not Confirmed
arrow
arrow
MAGHREB PHARMA
Not Confirmed

GEMCITABINE HYDROCHLORIDE

Brand Name : GEMCITABINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 200MG BASE/VIAL

Approval Date : 2016-01-05

Application Number : 204520

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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04

EUROHLTH INTL

United Kingdom
MAGHREB PHARMA
Not Confirmed
arrow

EUROHLTH INTL

United Kingdom
arrow
MAGHREB PHARMA
Not Confirmed

GEMCITABINE

Brand Name : GEMCITABINE

Dosage Form : INJECTABLE; INJECTION

Dosage Strength : 200MG

Approval Date :

Application Number : 78460

RX/OTC/DISCN :

RLD :

TE Code :

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05

HIKMA

United Kingdom
MAGHREB PHARMA
Not Confirmed
arrow

HIKMA

United Kingdom
arrow
MAGHREB PHARMA
Not Confirmed

GEMCITABINE HYDROCHLORIDE

Brand Name : GEMCITABINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 200MG/5.26ML (38MG/ML)

Approval Date : 2023-03-07

Application Number : 213175

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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06

HOSPIRA INC

U.S.A
MAGHREB PHARMA
Not Confirmed
arrow

HOSPIRA INC

U.S.A
arrow
MAGHREB PHARMA
Not Confirmed

GEMCITABINE HYDROCHLORIDE

Brand Name : GEMCITABINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 1GM/26.3ML (38MG/ML)

Approval Date : 2011-08-04

Application Number : 200795

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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07

MEITHEAL

U.S.A
MAGHREB PHARMA
Not Confirmed
arrow

MEITHEAL

U.S.A
arrow
MAGHREB PHARMA
Not Confirmed

GEMCITABINE HYDROCHLORIDE

Brand Name : GEMCITABINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 2GM/52.6ML (38MG/ML)

Approval Date : 2020-12-11

Application Number : 212129

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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08

SUN PHARM

India
MAGHREB PHARMA
Not Confirmed
arrow

SUN PHARM

India
arrow
MAGHREB PHARMA
Not Confirmed

GEMCITABINE HYDROCHLORIDE

Brand Name : GEMCITABINE HYDROCHLORIDE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 1GM BASE/VIAL

Approval Date : 2011-07-25

Application Number : 78433

RX/OTC/DISCN : RX

RLD : No

TE Code : AP

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09

SUN PHARM

India
MAGHREB PHARMA
Not Confirmed
arrow

SUN PHARM

India
arrow
MAGHREB PHARMA
Not Confirmed

GEMCITABINE HYDROCHLORIDE

Brand Name : INFUGEM

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)

Approval Date : 2018-07-16

Application Number : 208313

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

MAGHREB PHARMA
Not Confirmed
arrow
arrow
MAGHREB PHARMA
Not Confirmed

GEMCITABINE

Brand Name : GEMCITABINE

Dosage Form : INJECTABLE; INJECTION

Dosage Strength : 2G

Approval Date :

Application Number : 90644

RX/OTC/DISCN :

RLD :

TE Code :

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Europe

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01

Accord Healthcare AG

United Kingdom
MAGHREB PHARMA
Not Confirmed
arrow

Accord Healthcare AG

United Kingdom
arrow
MAGHREB PHARMA
Not Confirmed

Gemcitabine

Brand Name : Gemcitabine Accord

Dosage Form : Inf Conc

Dosage Strength : 1000mg/10ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

MAGHREB PHARMA
Not Confirmed
arrow
arrow
MAGHREB PHARMA
Not Confirmed

gemcitabine hydrochloride

Brand Name : Gitrabin

Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION

Dosage Strength : 40 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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03

MAGHREB PHARMA
Not Confirmed
arrow
arrow
MAGHREB PHARMA
Not Confirmed

Gemcitabine

Brand Name : Gemcitabin Fresenius Kabi

Dosage Form : Powder for infusion fluid, resolution

Dosage Strength : 1 g

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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04

MAGHREB PHARMA
Not Confirmed
arrow
arrow
MAGHREB PHARMA
Not Confirmed

Gemcitabine

Brand Name : Gemcitabine

Dosage Form : Gemcitabine 1.00026,3Mg Ml 1 Units Parenteral Use

Dosage Strength : 1 vial EV 1 g 26,3 ml 38 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

MAGHREB PHARMA
Not Confirmed
arrow
arrow
MAGHREB PHARMA
Not Confirmed

Gemcitabine

Brand Name : Gemcitabine

Dosage Form : Gemcitabine 2.00052,6Mg Ml 1 Units Parenteral Use

Dosage Strength : 1 vial EV 2 g 52.6 ml 38 mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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06

MAGHREB PHARMA
Not Confirmed
arrow
arrow
MAGHREB PHARMA
Not Confirmed

Gemcitabine

Brand Name : Gemcitabin Hospira

Dosage Form : Concentrate to the infusion fluid

Dosage Strength : 38 mg/ml

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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07

SANDOZ SpA

Switzerland
MAGHREB PHARMA
Not Confirmed
arrow

SANDOZ SpA

Switzerland
arrow
MAGHREB PHARMA
Not Confirmed

Gemcitabine

Brand Name : Gemsol

Dosage Form : Gemcitabine 1.000Mg 25Ml 1 Units Parenteral Use

Dosage Strength : 1 vial EV 1,000 mg 25 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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08

MAGHREB PHARMA
Not Confirmed
arrow
arrow
MAGHREB PHARMA
Not Confirmed

Gemcitabine

Brand Name : Gemcitabine Sandoz

Dosage Form : Inf L?s

Dosage Strength : 1000mg/100ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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09

MAGHREB PHARMA
Not Confirmed
arrow
arrow
MAGHREB PHARMA
Not Confirmed

gemcitabine hydrochloride

Brand Name : Gemcitabine SUN

Dosage Form : SOLUTION FOR INFUSION

Dosage Strength : 10 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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10

MAGHREB PHARMA
Not Confirmed
arrow
arrow
MAGHREB PHARMA
Not Confirmed

Gemcitabine

Brand Name : Gemcitabine

Dosage Form : Gemcitabine 1.000Mg 1 Unit Parenteral Use

Dosage Strength : 1 bottle EV 1 g Groun

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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DRUG PRODUCT COMPOSITIONS

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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

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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

read-more

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

USFDA APPLICATION NUMBER - 208313

read-more

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

USFDA APPLICATION NUMBER - 208313

read-more

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

USFDA APPLICATION NUMBER - 208313

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

USFDA APPLICATION NUMBER - 208313

read-more

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

USFDA APPLICATION NUMBER - 208313

read-more

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

USFDA APPLICATION NUMBER - 208313

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

USFDA APPLICATION NUMBER - 208313

read-more

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

USFDA APPLICATION NUMBER - 208313

read-more

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

USFDA APPLICATION NUMBER - 208313

read-more

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

Looking for 122111-03-9 / Gemcitabine API manufacturers, exporters & distributors?

Gemcitabine manufacturers, exporters & distributors 1

91

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

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

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

API | Excipient name

Gemcitabine

Synonyms

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

Cas Number

122111-03-9

Unique Ingredient Identifier (UNII)

U347PV74IL

About Gemcitabine

A deoxycytidine antimetabolite used as an antineoplastic agent.

Gemcitabine HCl Manufacturers

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

Gemcitabine HCl Suppliers

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

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

Gemcitabine HCl USDMF

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

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

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

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

Gemcitabine HCl KDMF

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

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

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

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

Gemcitabine HCl CEP

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

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

Gemcitabine HCl WC

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

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

Gemcitabine HCl 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 Gemcitabine HCl as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Gemcitabine HCl GMP

Gemcitabine HCl 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 Gemcitabine HCl 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 Gemcitabine HCl GMP manufacturer or Gemcitabine HCl GMP API supplier for your needs.

Gemcitabine HCl CoA

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

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

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