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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.)
API SUPPLIERS
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USDMF
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2015-02-20
Pay. Date : 2013-08-20
DMF Number : 27402
Submission : 2014-02-20
Status : Active
Type : II
TAPI offers customized CDMO Solutions for API development and manufacturing services.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-20
Pay. Date : 2012-12-03
DMF Number : 20979
Submission : 2007-10-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21274
Submission : 2008-01-22
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-08
Pay. Date : 2012-12-19
DMF Number : 21399
Submission : 2008-04-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18810
Submission : 2005-09-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22229
Submission : 2008-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22748
Submission : 2009-04-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22199
Submission : 2008-10-23
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-01-14
Pay. Date : 2013-11-21
DMF Number : 19053
Submission : 2005-12-19
Status : Active
Type : II
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Certificate Number : R1-CEP 2007-075 - Rev 06
Status : Valid
Issue Date : 2021-06-18
Type : Chemical
Substance Number : 2306
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Farmhispania Group, a leading European CDMO in HPAPI Technologies & High Potency Fermentation.
Certificate Number : R1-CEP 2011-032 - Rev 01
Status : Valid
Issue Date : 2017-09-27
Type : Chemical
Substance Number : 2306
Gemcitabine Hydrochloride, Product Code: GMI
Certificate Number : R0-CEP 2011-025 - Rev 01
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2014-04-25
Type : Chemical
Substance Number : 2306
Gemcitabine Hydrochloride, Product Code: GAI
Certificate Number : R0-CEP 2011-023 - Rev 01
Status : Withdrawn by EDQM Failure to CEP pro...
Issue Date : 2014-04-25
Type : Chemical
Substance Number : 2306
Certificate Number : R1-CEP 2013-226 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2020-05-12
Type : Chemical
Substance Number : 2306
Certificate Number : R1-CEP 2007-063 - Rev 00
Status : Valid
Issue Date : 2014-11-07
Type : Chemical
Substance Number : 2306
Gemcitabine Hydrochloride, Alternate Process
Certificate Number : R1-CEP 2012-080 - Rev 01
Status : Valid
Issue Date : 2019-10-08
Type : Chemical
Substance Number : 2306
Certificate Number : R1-CEP 2009-042 - Rev 01
Status : Valid
Issue Date : 2015-10-16
Type : Chemical
Substance Number : 2306
Certificate Number : R1-CEP 2009-208 - Rev 02
Status : Valid
Issue Date : 2020-11-02
Type : Chemical
Substance Number : 2306
Gemcitabine Hydrochloride, Process-2
Certificate Number : R0-CEP 2015-054 - Rev 00
Status : Expired
Issue Date : 2015-07-31
Type : Chemical
Substance Number : 2306
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API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 200MG/Vial
Packaging :
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Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 1G/Vial
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Application Number :
Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Lyophilised Injection
Dosage Strength : 1.4G/Vial
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Regulatory Info :
Registration Country : India
Naprod is a top player in Oncology & Anesthesia FDF through excellent innovation, discovery of new processes & high-quality production.
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Registration Country : India
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Dosage Form : Liquid Injection
Dosage Strength : 10MG/ML
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Registration Country : India
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Tiagem
Dosage Form : Vial
Dosage Strength : 200MG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
NanoAlvand is the entrance to Global Markets as a trusted Highly Potent Products manufacturer.
Regulatory Info :
Registration Country : Iran
Brand Name : Tiagem
Dosage Form : Vial
Dosage Strength : 1000MG/10ML
Packaging :
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Application Number :
Regulatory Info :
Registration Country : Iran
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 200MG/2ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Supriya Lifesciences is a cGMP-compliant API manufacturing organization with a leadership position across key & niche products.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 100MG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : GEMCITABINE HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 1.5GM/15ML (100MG/ML)
Packaging :
Approval Date : 2017-08-03
Application Number : 209604
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Norway
Brand Name : Gemcitabine Accord
Dosage Form : Powder for infusion fluid, resolution
Dosage Strength : 200 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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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
A Gemcitabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gemcitabine, including repackagers and relabelers. The FDA regulates Gemcitabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gemcitabine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gemcitabine supplier is an individual or a company that provides Gemcitabine active pharmaceutical ingredient (API) or Gemcitabine finished formulations upon request. The Gemcitabine suppliers may include Gemcitabine API manufacturers, exporters, distributors and traders.
click here to find a list of Gemcitabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gemcitabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Gemcitabine active pharmaceutical ingredient (API) in detail. Different forms of Gemcitabine DMFs exist exist since differing nations have different regulations, such as Gemcitabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gemcitabine DMF submitted to regulatory agencies in the US is known as a USDMF. Gemcitabine USDMF includes data on Gemcitabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gemcitabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gemcitabine 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 Gemcitabine Drug Master File in Japan (Gemcitabine JDMF) empowers Gemcitabine 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Gemcitabine 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 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 Gemcitabine Drug Master File in Korea (Gemcitabine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gemcitabine. The MFDS reviews the Gemcitabine KDMF as part of the drug registration process and uses the information provided in the Gemcitabine KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gemcitabine 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gemcitabine suppliers with KDMF on PharmaCompass.
A Gemcitabine CEP of the European Pharmacopoeia monograph is often referred to as a Gemcitabine Certificate of Suitability (COS). The purpose of a Gemcitabine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gemcitabine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gemcitabine to their clients by showing that a Gemcitabine CEP has been issued for it. The manufacturer submits a Gemcitabine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gemcitabine CEP holder for the record. Additionally, the data presented in the Gemcitabine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gemcitabine DMF.
A Gemcitabine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gemcitabine 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 suppliers with CEP (COS) on PharmaCompass.
A Gemcitabine written confirmation (Gemcitabine WC) is an official document issued by a regulatory agency to a Gemcitabine manufacturer, verifying that the manufacturing facility of a Gemcitabine active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Gemcitabine APIs or Gemcitabine finished pharmaceutical products to another nation, regulatory agencies frequently require a Gemcitabine WC (written confirmation) as part of the regulatory process.
click here to find a list of Gemcitabine 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 Gemcitabine as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gemcitabine 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 Gemcitabine 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 Gemcitabine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gemcitabine NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gemcitabine suppliers with NDC on PharmaCompass.
Gemcitabine 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 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 GMP manufacturer or Gemcitabine GMP API supplier for your needs.
A Gemcitabine CoA (Certificate of Analysis) is a formal document that attests to Gemcitabine's compliance with Gemcitabine specifications and serves as a tool for batch-level quality control.
Gemcitabine CoA mostly includes findings from lab analyses of a specific batch. For each Gemcitabine 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Gemcitabine EP), Gemcitabine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gemcitabine USP).
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