Shilpa Medicare Limited
 
" ASMF/EDMF submitted to 27 European Countries…"
Sr.No. Name of Active Ingredient Name of Regulatory Authority Country Dt. of Submission
01. Irinotecan HCl Trihydrate MHRA United Kingdom 05.06.2007
02. Irinotecan HCl Trihydrate Medical Products Agency Sweden 26.04.2007
03. Irinotecan HCl Trihydrate AEMPS Spain 26.04.2007
04. Irinotecan HCl Trihydrate CBG - Medicines Evaluation Board The Netherlands 26.04.2007
05. Irinotecan HCl Trihydrate BASG Austria 26.04.2007
06. Irinotecan HCl Trihydrate Afdeling Registratie (fagg.amps) Belgium 26.04.2007
07. Irinotecan HCl Trihydrate State Institute for Drug Control Czech Republic 26.04.2007
08. Irinotecan HCl Trihydrate Lægemiddelstyrelsen Denmark 26.04.2007
09. Irinotecan HCl Trihydrate National Agency for Medicines Finland 26.04.2007
10. Irinotecan HCl Trihydrate Országos Gyógyszerészeti Intézet Hungary 26.04.2007
11. Irinotecan HCl Trihydrate BfArM Germany 10.01.2007
12. Irinotecan HCl Trihydrate Irish Medicines Board Ireland 26.04.2007
13. Irinotecan HCl Trihydrate AIFA - Agenzia Italiana del Farmaco Italy 26.04.2007
14. Irinotecan HCl Trihydrate INFARMED Portugal 26.04.2007
15. Irinotecan HCl Trihydrate Medical Devices and Biocides Poland 26.04.2007
16. Irinotecan HCl Trihydrate Norvegian Medicines Agency (noMA) Norway 26.04.2007
17. Irinotecan HCl Trihydrate State Agency of Medicines Estonia 26.04.2007
18. Irinotecan HCl Trihydrate Latvia State Agency of Medicines Latvia 26.04.2007
19. Irinotecan HCl Trihydrate State Medicines Control Agency Lithuania 26.04.2007
20. Irinotecan HCl Trihydrate State Institute for Drug Control Slovak Republic 26.04.2007
21. Irinotecan HCl Trihydrate Bulgarian Drug Agency Bulgaria 11.12.2007
22. Irinotecan HCl Trihydrate The Registrar Drugs Council Cyprus 11.12.2007
23. Irinotecan HCl Trihydrate Registration Division, EOF Greece 11.12.2007
24. Irinotecan HCl Trihydrate AFSSAPS France 11.12.2007
25. Irinotecan HCl Trihydrate Division de la Pharmacie et des Luxemburg 11.12.2007
26. Irinotecan HCl Trihydrate National Medicines Agency Romania 11.12.2007
27. Irinotecan HCl Trihydrate Agency for Medicinal Products Slovenia 11.12.2007
28. Gemcitabine HCl MHRA United Kingdom 05.06.2007
29. Gemcitabine HCl Medical Products Agency Sweden 05.05.2007
30. Gemcitabine HCl AEMPS Spain 05.05.2007
31. Gemcitabine HCl CBG - Medicines Evaluation Board The Netherlands 05.05.2007
32. Gemcitabine HCl BASG Austria 05.05.2007
33. Gemcitabine HCl Afdeling Registratie (fagg.amps) Belgium 05.05.2007
34. Gemcitabine HCl State Institute for Drug Control Czech Republic 05.05.2007
35. Gemcitabine HCl Lægemiddelstyrelsen Denmark 05.05.2007
36. Gemcitabine HCl National Agency for Medicines Finland 05.05.2007
37. Gemcitabine HCl Országos Gyógyszerészeti Intézet Hungary 05.05.2007
38. Gemcitabine HCl BfArM Germany 27.02.2007
39. Gemcitabine HCl Irish Medicines Board Ireland 05.05.2007
40. Gemcitabine HCl AIFA - Agenzia Italiana del Farmaco Italy 05.05.2007
41. Gemcitabine HCl INFARMED Portugal 05.05.2007
42. Gemcitabine HCl Medical Devices and Biocides Poland 05.05.2007
43. Gemcitabine HCl Norvegian Medicines Agency (noMA) Norway 05.05.2007
44. Gemcitabine HCl State Agency of Medicines Estonia 05.05.2007
45. Gemcitabine HCl Latvia State Agency of Medicines Latvia 05.05.2007
46. Gemcitabine HCl State Medicines Control Agency Lithuania 05.05.2007
47. Gemcitabine HCl
State Institute for Drug Control
Slovak Republic 05.05.2007
48. Gemcitabine HCl EP AFSSAPS France 11.08.2007
49. Terfenadine CBG - Medicines Evaluation Board The Netherlands 01.06.2005
50. Ambroxol HCl BfArM Germany 16.06.2006
51. Ambroxol HCl National Drug Agency
Romania 21.04.2007
52. Oxaliplatin
MHRA
United Kingdom
12.10.2007
53. Oxaliplatin
AEMPS
Spain
12.10.2007
54. Oxaliplatin
CBG – Medicines Evaluation Board
The Netherlands
12.10.2007
55. Oxaliplatin
National Medicines Agency
Romania
12.10.2007
56. Oxaliplatin
AIFA – Agenzia Italiana del Farmaco
Italy
12.10.2007
57. Oxaliplatin
INFARMED
Portugal
12.10.2007
58. Oxaliplatin Medical Products Agency
Sweden
12.10.2007
59. Oxaliplatin Lægemiddelstyrelsen
Denmark
12.10.2007
60. Oxaliplatin BfArM
Germany
12.10.2007
61. Oxaliplatin Medical Devices and Biocides
Poland
12.10.2007
62. Oxaliplatin EP AFSSAPS France 17.12.2007
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KDMF's submitted to Korean FDA
Sr.No.
Name of Active Ingredient
Date of Submission
01. Ambroxol HCl February 22, 2006
02. Gemcitabine HCl January 4, 2007
 
COS submitted to EDQM
Sr.No.
Name of Active Ingredient
Certificate Date
CEP#
01. Ambroxol HCl June 30, 2004 R0-CEP 2004-201-Rev 00
02. Ticlopidine December 2, 2004 R0-CEP 2005-004-Rev 00
03. Buflomedil HCl February 1, 2008 CEP # R0-CEP 2006-080-Rev.00)
04. Oxaliplatin February 29, 2008 CEP # R0-CEP 2006-201-Rev.00)
05. Carboplatin November 16, 2007 R0-CEP 2006-212-Rev 00
06. Gemcitabine HCl Dossier under review at EDQM (Submitted on Sept 13, 2006)
 
DMF's submitted to TPD, Health Canada
Sr.No.
Name of Active Ingredient
Date of Submission
01. Irinotecan HCl Trihydrate December 28, 2006
02. Gemcitabine HCl December 30, 2006
03. Gemcitabine HCl June 8, 2007
04. Bicalutamide March 28, 2005
05. Oxaliplatin December 24, 2005
 
 
 
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