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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
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
1. Gemcitabine Free Base
| Molecular Weight | 299.66 g/mol |
|---|---|
| Molecular Formula | C9H12ClF2N3O4 |
| 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 Ų |
| 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 |
| 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 |
Treatment of urothelial carcinoma
Antimetabolites, Antineoplastic
Antimetabolites that are useful in cancer chemotherapy. (See all compounds classified as Antimetabolites, Antineoplastic.)
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Drugs in Development
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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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37
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.
A Gemsar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gemsar, including repackagers and relabelers. The FDA regulates Gemsar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gemsar 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 Gemsar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gemsar supplier is an individual or a company that provides Gemsar active pharmaceutical ingredient (API) or Gemsar finished formulations upon request. The Gemsar suppliers may include Gemsar API manufacturers, exporters, distributors and traders.
click here to find a list of Gemsar suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gemsar DMF (Drug Master File) is a document detailing the whole manufacturing process of Gemsar active pharmaceutical ingredient (API) in detail. Different forms of Gemsar DMFs exist exist since differing nations have different regulations, such as Gemsar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gemsar DMF submitted to regulatory agencies in the US is known as a USDMF. Gemsar USDMF includes data on Gemsar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gemsar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gemsar suppliers with USDMF on PharmaCompass.
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 Gemsar Drug Master File in Japan (Gemsar JDMF) empowers Gemsar 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 Gemsar JDMF during the approval evaluation for pharmaceutical products. At the time of Gemsar 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 Gemsar suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Gemsar Drug Master File in Korea (Gemsar KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gemsar. The MFDS reviews the Gemsar KDMF as part of the drug registration process and uses the information provided in the Gemsar KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gemsar 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 Gemsar API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gemsar suppliers with KDMF on PharmaCompass.
A Gemsar CEP of the European Pharmacopoeia monograph is often referred to as a Gemsar Certificate of Suitability (COS). The purpose of a Gemsar CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gemsar EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gemsar to their clients by showing that a Gemsar CEP has been issued for it. The manufacturer submits a Gemsar CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gemsar CEP holder for the record. Additionally, the data presented in the Gemsar CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gemsar DMF.
A Gemsar CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gemsar 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 Gemsar suppliers with CEP (COS) on PharmaCompass.
A Gemsar written confirmation (Gemsar WC) is an official document issued by a regulatory agency to a Gemsar manufacturer, verifying that the manufacturing facility of a Gemsar active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gemsar APIs or Gemsar finished pharmaceutical products to another nation, regulatory agencies frequently require a Gemsar WC (written confirmation) as part of the regulatory process.
click here to find a list of Gemsar suppliers with Written Confirmation (WC) on PharmaCompass.
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 Gemsar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gemsar API and other APIs are published in this directory by the FDA.
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 Gemsar 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.
The NDC directory also contains data on finished compounded human drug products that contain Gemsar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gemsar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gemsar suppliers with NDC on PharmaCompass.
Gemsar 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 Gemsar 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 Gemsar GMP manufacturer or Gemsar GMP API supplier for your needs.
A Gemsar CoA (Certificate of Analysis) is a formal document that attests to Gemsar's compliance with Gemsar specifications and serves as a tool for batch-level quality control.
Gemsar CoA mostly includes findings from lab analyses of a specific batch. For each Gemsar 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.
Gemsar may be tested according to a variety of international standards, such as European Pharmacopoeia (Gemsar EP), Gemsar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gemsar USP).
