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LIST OF CERTIFICATE OF SUITABILITY (COS) GRANTED FROM EDQM |
| Sr.No. |
Name
of Active Ingredient |
|
CEP No. |
|
|
|
|
| 01. |
Ambroxol HCl EP |
February 28 2008 |
R0-CEP 2004-201-Rev 01 |
|
|
|
|
|
| 04. |
Buflomedil HCl EP |
February 1, 2008 |
R0-CEP 2006-080-Rev 00 |
|
|
|
|
|
| 03. |
Carboplatin EP |
April 1 2009 |
R0-CEP 2006-212-Rev 01 |
|
|
|
|
|
| 06. |
Gemcitabine HCl EP |
March 24 2009 |
R0-CEP 2006-222-Rev 01 |
|
|
|
|
|
| 05. |
Oxaliplatin EP |
February 29, 2008 |
R0-CEP 2006-201-Rev 01 |
|
|
|
|
|
| 02. |
Ticlopidine HCl EP |
March 24 2009 |
R0-CEP 2005-004-Rev 02 |
|
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| |
LIST OF KDMF SUBMISSION & APPROVAL DETAILS |
| Sr.No. |
Name
of Active Ingredient |
| Name of the Regulatory Authority |
|
|
|
|
|
|
|
| 01. |
Ambroxol HCl |
Korean FDA |
February 22, 2006 |
|
|
|
|
|
| 02. |
Gemcitabine |
Korean FDA |
January 4, 2007 |
|
|
|
|
|
| |
LIST OF DMF SUBMIITED TO TPD, HEALTH CANADA |
| Sr.No. |
Name
of Active Ingredient |
| Name of the Regulatory Authority |
|
|
|
|
|
|
|
| 04. |
Bicalutamide |
TPD, Health Canada |
March 28, 2005 |
|
|
|
|
|
| 02. |
Gemcitabine HCl |
TPD, Health Canada |
December 30, 2006 |
|
|
|
|
|
| 03. |
Gemcitabine HCl |
TPD, Health Canada |
June 8, 2007 |
|
|
|
|
|
| 01. |
Irinotecan HCl Trihydrate |
TPD, Health Canada |
December 28, 2006 |
|
|
|
|
|
| 05. |
Oxaliplatin |
TPD, Health Canada |
December 24, 2005 |
|
|
|
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| top |
LIST OF ASMF SUBMISSION DETAILS FOR IRINOTECAN HCl TRIHYDRATE |
| Sr.No. |
Name
of Active Ingredient |
Name
of Regulatory Authority |
Country |
Dt.
of Submission |
|
|
|
|
|
| 01. |
Irinotecan HCl Trihydrate |
Medical Products Agency |
Sweden |
April 26, 2007 |
|
|
|
|
|
| 02. |
Irinotecan HCl Trihydrate |
AEMPS |
Spain |
April 26, 2007 |
|
|
|
|
|
| 03. |
Irinotecan HCl Trihydrate |
Medicines Evaluation Board |
The Netherlands |
April 26, 2007 |
|
|
|
|
|
| 04. |
Irinotecan HCl Trihydrate |
BASG |
Austria |
April 26, 2007 |
|
|
|
|
|
| 05. |
Irinotecan HCl Trihydrate |
Afdeling Registratie |
Belgium |
April 26, 2007 |
|
|
|
|
|
| 06. |
Irinotecan HCl Trihydrate |
State Institute for Drug Control |
Czech Republic |
April 26, 2007 |
|
|
|
|
|
| 07. |
Irinotecan HCl Trihydrate |
Laegemiddelstyrelsen |
Denmark |
April 26, 2007 |
|
|
|
|
|
| 08. |
Irinotecan HCl Trihydrate |
National Agency for Medicines |
Finland |
April 26, 2007 |
|
|
|
|
|
| 09. |
Irinotecan HCl Trihydrate |
Orszagos |
Hungary |
April 26, 2007 |
|
|
|
|
|
| 10. |
Irinotecan HCl Trihydrate |
Bfarm |
Germany |
April 26, 2007 |
|
|
|
|
|
| 11. |
Irinotecan HCl Trihydrate |
Irish Medicines Board |
Ireland |
April 26, 2007 |
|
|
|
|
|
| 12. |
Irinotecan HCl Trihydrate |
AIFA |
Italy |
April 26, 2007 |
|
|
|
|
|
| 13. |
Irinotecan HCl Trihydrate |
INFARMED |
Portugal |
April 26, 2007 |
|
|
|
|
|
| 14. |
Irinotecan HCl Trihydrate |
Office of Medicinal Products |
Poland |
April 26, 2007 |
|
|
|
|
|
| 15. |
Irinotecan HCl Trihydrate |
Norvegian Medicines Agency |
Norway |
April 26, 2007 |
|
|
|
|
|
| 16. |
Irinotecan HCl Trihydrate |
State Agency of Medicines |
Estonia |
April 26, 2007 |
|
|
|
|
|
| 17. |
Irinotecan HCl Trihydrate |
Latvia State Agency of Med. |
Latvia |
April 26, 2007 |
|
|
|
|
|
| 18. |
Irinotecan HCl Trihydrate |
State Medicines Control |
Lithuania |
April 26, 2007 |
|
|
|
|
|
| 19. |
Irinotecan HCl Trihydrate |
State Institute for Drug Control |
Slovak Republic |
April 26, 2007 |
|
|
|
|
|
| 20. |
Irinotecan HCl Trihydrate |
MHRA |
UK |
June 6, 2007 |
|
|
|
|
|
| 21. |
Irinotecan HCl Trihydrate |
Bulgarian Drug Agency |
Bulgaria |
December 11, 2007 |
|
|
|
|
|
| 22. |
Irinotecan HCl Trihydrate |
The Registrar Drugs Council |
Cyprus |
December 11, 2007 |
|
|
|
|
|
| 23. |
Irinotecan HCl Trihydrate |
Registration Division, EOF |
Greece |
December 11, 2007 |
|
|
|
|
|
| 24. |
Irinotecan HCl Trihydrate |
AFSSAPS |
France |
December 11, 2007 |
|
|
|
|
|
| 25. |
Irinotecan HCl Trihydrate |
Division de la Pharmacie et des |
Luxemburg |
December 11, 2007 |
|
|
|
|
|
| 26. |
Irinotecan HCl Trihydrate |
National Medicines Agency |
Romania |
December 11, 2007 |
|
|
|
|
|
| 27. |
Irinotecan HCl Trihydrate |
Agency for Medicinal Products |
Slovenia |
December 11, 2007 |
|
|
|
|
|
| 28. |
Irinotecan HCl Trihydrate |
Swissmedic |
Switzerland |
November 21 2008 |
|
|
|
|
|
|
| top |
LIST OF ASMF SUBMISSION DETAILS FOR OXALIPLATIN |
| Sr.No. |
Name
of Active Ingredient |
Name
of Regulatory Authority |
Country |
Dt.
of Submission |
|
|
|
|
|
| 01. |
Oxaliplatin EP |
MHRA |
UK |
October 12, 2007 |
|
|
|
|
|
| 02. |
Oxaliplatin EP |
AEMPS |
Spain |
October 12, 2007 |
|
|
|
|
|
| 03. |
Oxaliplatin EP |
Medicines Evaluation Board |
The Netherlands |
October 12, 2007 |
|
|
|
|
|
| 04. |
Oxaliplatin EP |
National Medicines Agency |
Romania |
October 12, 2007 |
|
|
|
|
|
| 05. |
Oxaliplatin EP |
AIFA |
Italy |
October 12, 2007 |
|
|
|
|
|
| 06. |
Oxaliplatin EP |
INFARMED |
Portugal |
October 12, 2007 |
|
|
|
|
|
| 07. |
Oxaliplatin EP |
Medical Products Agency |
Sweden |
October 12, 2007 |
|
|
|
|
|
| 08. |
Oxaliplatin EP |
Lægemiddelstyrelsen |
Denmark |
October 12, 2007 |
|
|
|
|
|
| 09. |
Oxaliplatin EP |
BfArM |
Germany |
October 12, 2007 |
|
|
|
|
|
| 10. |
Oxaliplatin EP |
Office for Registration |
Poland |
October 12, 2007 |
|
|
|
|
|
| 11. |
Oxaliplatin EP |
AFSSAPS |
France |
December 17, 2007 |
|
|
|
|
|
|
| top |
LIST OF ASMF SUBMISSION DETAILS FOR GEMCITABINE HCl EP |
| Sr.No. |
Name
of Active Ingredient |
Name
of Regulatory Authority |
Country |
Dt.
of Submission |
|
|
|
|
|
| 01. |
Gemcitabine HCl EP |
TGA |
Australia |
April 25, 2008 |
|
|
|
|
|
| 02. |
Gemcitabine HCl EP |
Medsafe |
New Zealand |
April 25, 2008 |
|
|
|
|
|
| 03. |
Gemcitabine HCl EP |
BFSG |
Austria |
December 26, 2007 |
|
|
|
|
|
| 04. |
Gemcitabine HCl EP |
Federal Agency for Medicines |
Belgium |
December 26, 2007 |
|
|
|
|
|
| 05. |
Gemcitabine HCl EP |
Bulgarian Drug Agency |
Bulgaria |
December 26, 2007 |
|
|
|
|
|
| 06. |
Gemcitabine HCl EP |
State Institute for Drug Control |
Czech Rep. |
December 26, 2007 |
|
|
|
|
|
| 07. |
Gemcitabine HCl EP |
Lægemiddelstyrelsen |
Denmark |
December 26, 2007 |
|
|
|
|
|
| 08. |
Gemcitabine HCl EP |
State Agency of Medicines |
Estonia |
December 26, 2007 |
|
|
|
|
|
| 09. |
Gemcitabine HCl EP |
National Agency for Medicines |
Finland |
December 26, 2007 |
|
|
|
|
|
| 10. |
Gemcitabine HCl EP |
AFSSAPS |
France |
December 26, 2007 |
|
|
|
|
|
| 11. |
Gemcitabine HCl EP |
BFARM |
Germany |
December 26, 2007 |
|
|
|
|
|
| 12. |
Gemcitabine HCl EP |
Registration Division, EOF |
Greece |
December 26, 2007 |
|
|
|
|
|
| 13. |
Gemcitabine HCl EP |
Országos Gyógyszerészeti Intézet |
Hungary |
December 26, 2007 |
|
|
|
|
|
| 14. |
Gemcitabine HCl EP |
Icelandic Medicines Control Agency |
Iceland |
September 29 2008 |
|
|
|
|
|
| 15. |
Gemcitabine HCl EP |
Irish Medicines Board |
Ireland |
December 26, 2007 |
|
|
|
|
|
| 16. |
Gemcitabine HCl EP |
AIFA |
Italy |
April 17, 2008 |
|
|
|
|
|
| 17. |
Gemcitabine HCl EP |
State Agency of Medicines |
Latvia |
December 26, 2007 |
|
|
|
|
|
| 18. |
Gemcitabine HCl EP |
State Medicines Control Agency |
Lithuania |
December 26, 2007 |
|
|
|
|
|
| 19. |
Gemcitabine HCl EP |
Division de la Pharmacie et des |
Luxembourg |
April 17, 2008 |
|
|
|
|
|
| 20. |
Gemcitabine HCl EP |
Medicines Authority |
Malta |
September 29 2008 |
|
|
|
|
|
| 21. |
Gemcitabine HCl EP |
Medicines Evaluation Board |
Netherlands |
December 26, 2007 |
|
|
|
|
|
| 22. |
Gemcitabine HCl EP |
Statens legemiddelverk |
Norway |
December 26, 2007 |
|
|
|
|
|
| 23. |
Gemcitabine HCl EP |
The Office for Registration |
Poland |
December 26, 2007 |
|
|
|
|
|
| 24. |
Gemcitabine HCl EP |
INFARMED |
Portugal |
December 26, 2007 |
|
|
|
|
|
| 25. |
Gemcitabine HCl EP |
National Medicines Agency |
Romania |
December 26, 2007 |
|
|
|
|
|
| 26. |
Gemcitabine HCl EP |
State Institute for Drug Control |
Slovak Rep. |
December 26, 2007 |
|
|
|
|
|
| 27. |
Gemcitabine HCl EP |
Agency for Medicinal Products |
Slovenia |
December 26, 2007 |
|
|
|
|
|
| 28. |
Gemcitabine HCl EP |
AEMPS |
Spain |
December 26, 2007 |
|
|
|
|
|
| 29. |
Gemcitabine HCl EP |
Drug Agency of Republic of Srpska |
Srpska |
November 3 2008 |
|
|
|
|
|
| 30. |
Gemcitabine HCl EP |
Medical Products Agency |
Sweden |
December 26, 2007 |
|
|
|
|
|
| 31. |
Gemcitabine HCl EP |
MHRA |
UK |
December 26, 2007 |
|
|
|
|
|
| 32 |
Gemcitabine HCl EP |
The State Administration on Medicinal |
Ukraine |
November 3 2008 |
|
|
|
|
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| top |
LIST OF ASMF SUBMISSION DETAILS FOR TEMOZOLOMIDE |
| Sr.No. |
Name
of Active Ingredient |
Name
of Regulatory Authority |
Country |
Dt.
of Submission |
|
|
|
|
|
| 01. |
Temozolomide |
EMEA |
London |
29.01.2009 |
|
|
|
|
|
| 02. |
Temozolomide |
INFARMED |
Portugal |
29.01.2009 |
|
|
|
|
|
| 03. |
Temozolomide |
Medical Products Agency |
Sweden |
29.01.2009 |
|
|
|
|
|
| 04. |
Temozolomide |
CBG-MEB |
The Netherlands |
13.02.2009 |
|
|
|
|
|
| 05. |
Temozolomide |
BfARM |
Germany |
26.03.2009 |
|
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| top |
| |
 |
| Copyrights Reserved
2007. Shilpa Medicare Ltd. |
Disclaimer |
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