JavaScript must be enabled in order for you to use the Site in standard view. However, it seems JavaScript is either disabled or not supported by your browser. To use standard view, enable JavaScript by changing your browser options.

Last updated on : 17/07/2015
You are here:  HOME | Approval | CT APPROVAL 2013

Approval

CT APPROVAL 2013

 

Monthwise status of CT NOC granted by CDSCO during the period January 2013 to December 2013

S.NO

MONTH

NUMBER OF CT APPROVALS GRANTED

01

January 2013

00

02

February 2013

00

03

March 2013

06

04

April 2013

01

05

May 2013

17

06

June 2013

01

07

July 2013

00

08

August 2013

18

09

September 2013

26

10

October 2013

08

11

November 2013

07

12

December 2013

23

Total

107

CT NOC 2013

S.No

Drug

Firm

Category

1

Misoprostol

Dr. Pikee Saxena

Institutional

2

N acetyl cycteine & Metformin

Dr. Pikee Saxena

Institutional

3

Mertonomic

Dr. Sameer Bakshi

Institutional

4

Bethomethosone oral mini pulse

Dr. Suman Patra

Institutional

5

Dexamedetomidine

Dr. Lokesh Kashyap

Institutional

6

Atorvastatin

Dr. Bikash Medhi

Institutional

7

Surfactant for Prophylaxis

Dr. Nutan Aggarwal

Institutional

8

Thalidomide

Dr. Shasthry

Institutional

9

GRC 17536

Glenmark Pharmaceuticals

IND

10

S0597

Sun Pharma Advance Research Co. Ltd.

IND

11

DRL-17822

Dr. Reddy's Laboratories Ltd.

IND

12

Platelet Rich Plasma

Dr. Raje Amrut Diwikar

Institutional

13

Rebamipide

Dr. Radhika Tandon

Institutional

14

Primaquine

Dr. Anup Anvikar

Institutional

15

Oral Immunomodulator

Dr. H K Kar

Institutional

16

Platalet Rich Plasma

Dr. Vijay Kr. Jain

Institutional

17

Endoxifen

Intas Pharmaceuticals Ltd.

IND

18

Ibutilide Fumarate

Zuventus Healthcare Ltd.

ND

19

Trimethobenzamide Hcl 300 mg

Lupin Limited

ND

20

Vilazodone Hcl 40 mg

MSN Laboratories Ltd.

ND

21

Arterolane maleate 37.5 mg & Piperaquine Phosphate 187.5 mg

Ranbaxy Laboratories Ltd.

IND

22

Vilazodone

Hetero Labs Limited

ND

23

Maclofenamate Capsule

Lupin Limited

ND

24

Moxifloxacin 400 mg + Rifampcin 600 mg + Minocycline 200 mg

Dr. H K Kar

Institutional

25

Palonosetron

Dr. Yogesh Roy

Institutional

26

Pulse Steroid

Dr. Nilesh Nolkha

Institutional

27

Simvastatin

Dr. Deepak Thapa

Institutional

28

Oral  & Vaginal Probiotic

Dr. Varsha Gupta

Institutional

29

Roflumilast Tablet

Cadila Healthcare

ND

30

Roflumilast + Salmeterol

MSN Laboratories Ltd.

ND

31

DS5565 Metformin

Ranbaxy Laboratories Ltd.

IND

32

Bioplatin

Rasayani Biologicals

IND

33

GRC 17536

Glenmark Pharmaceuticals

IND

34

Arabackacin

Alkem Labs Ltd.

ND

35

Saroglitazar 4 mg

Cadila Healthcare

IND

36

Trastuzumab

Mabpharma

Biological Recombinant

37

Reteplase(RTPR-004)

Reliance life science

Biological Recombinant

38

Rituximab

Cadila Healthcare

Biological Recombinant

39

Pegfilgrastim

Quintiles phase one clinical trials pvt.ltd.

Biological Recombinant

40

Pegfilgrastim

Reliance life science

Biological Recombinant

41

Rituximab

Hetero Drugs

Biological Recombinant

42

Etanercept

Intas Pharmaceuticals Ltd

Biological Recombinant

43

Peg EPO

Intas Pharmaceuticals Ltd

Biological Recombinant

44

Humira(adalimumab)

Cadila Healthcare

Biological Recombinant

45

Teriparatide

Intas Pharmaceuticals Ltd

Biological Recombinant

46

Darbepoetin

Reliance life science

Biological Recombinant

47

Ranibizumab

Intas Pharmaceuticals Ltd

Biological Recombinant

48

Peg-filgrastim

GVK Bioscience

Biological Recombinant

49

Teriparatide

Lupin limited

Biological Recombinant

50

Tenectaplase (TNK-TPA)

Gennova biopharmaceuticals

Biological Recombinant

51

Adalimumab

Reliance life science

Biological Recombinant

52

SMRX-11

Symmetrix Biotech Private Limited

Biological Recombinant

53

Pneumococcal conjugate vaccine (PCV-13) and Hib conjugate vaccine 

Indian Institute of Technology Kharagpur

Biological (Vaccine)

54

Liquid Pentavalent Vaccine (DTP-HB-Hib)(Pentavac)

M/s Serum Institute of India Ltd., Pune

Biological (Vaccine)

55

Liquid, combined Hexavalent (DTaP-IPV(type 1, 2 and 3)-rHep B Hib PRP-TT vaccine (Hexaxim),

M/s Sanofi  Pasteur India Pvt. Ltd., Mumbai-

Biological (Vaccine)

56

10 - valent Pneumococcal

M/s Serum Institute of India Ltd. Pune

Biological (Vaccine)

57

Td vaccine

M/s Biological E. ltd, Hyderabad

Biological (Vaccine)

58

Vi-DT typhoid Conjugate vaccine

M/s Shantha Biotechnics ltd.,

Biological (Vaccine)

59

13-Valent pneumococcal conjugate vaccine

M/s Wyeth Ltd., Mumbai

Biological (Vaccine)

60

Combined DTwP-Hib Vaccine

M/s Cadila Healthcare Ahmadabad

Biological (Vaccine)

61

Diphtheria tetanus and pertussis

M/s Cadila Healthcare Ahmadabad

Biological (Vaccine)

62

Tetanus Toxoid Vaccine

M/s Cadila Healthcare Ahmadabad

Biological (Vaccine)

63

Combined DT Vaccine

M/s Cadila Healthcare Ahmadabad

Biological (Vaccine)

64

Hib Vaccine

Cadila Healthcare

Biological (Vaccine)

65

Mycobacterium w in combination with standard therapy versus standard therapy alone in sepsis

Cadila Pharmaceutical, Ahmadabad

Biological (Vaccine)

66

Inactivated Poliovirus Vaccine on Gut Immunity against Poliovirus

M/s Christian Medical College, Vellore

Biological (Vaccine)

67

Live Attenuated Bovine-Human Rotavirus Reassortant Pentavalent vaccine (BRV-PV)

M/s Serum Institute of India Ltd., Pune

Biological (Vaccine)

68

bivalent Oral Poliovirus vaccine and Trivalent Oral Poliovirus Vaccine

M/s Panacea Biotec Ltd, New Delhi

Biological (Vaccine)

69

MMR vaccine (Tresivac)

M/s Serum Institute of India Ltd., Pune

Biological (Vaccine)

70

Rabies G Protein

M/s Cadila Pharmaceutical Ltd. Ahmadabad

Biological (Vaccine)

71

Measles vaccine Live (Single and multi dose)

M/s Cadila Healthcare Ltd., Ahmadabad

Biological (Vaccine)

72

Measles, Mumps and Rubella (MMR) Vaccine (Live) (Freeze-dried), Single and Multidose

M/s Cadila Healthcare Ltd., Ahmadabad

Biological (Vaccine)

73

Japanese Encephalitis Vaccine

M/s Biological E Ltd, A.P

Biological (Vaccine)

74

Japanese Encephalitis Vaccine

M/s Bharat Biotech International ltd., Hyderabad

Biological (Vaccine)

75

Tapentadol HCl nasal spray 250 mg/ml & 385 mg/ml

M/s Torrent Pharma

SND

76

Lubiprostone Soft Gelatin Capsules 24mcg

M/s Sun Pharma

SND

77

Ondansetron SR Tablets 16mg

M/s Inventia Healthcare

SND

78

Aceclofenac Gel 5%w/w

M/s Inventia Healthcare

SND

79

Salbutamol Pressurised Inhalation (100 mcg per actuation) CFC free pMDI.

M/s Glenmark Pharma

SND

80

Linezolid SR Tablet 1200mg

M/s Inventia Healthcare

SND

81

Ebastine 10mg + Montelukast 10mg tablet

Micro Labs Ltd

FDC

82

Cilotazole 40mg + Telmisartan 10mg tablet

Connexios Life Sciences Pvt. Ltd

FDC

83

Ceftriaxone sodium 1000mg + Sulbactam Sodium 500mg + Edetate Di Sodium 37mg powder for solution for injection/infusion

Venus Remedies Ltd.,

FDC

84

silver sulfadazie cream (Nanonized) 0.5% w/w and silerex cream 1% w/w

Ranbaxy Laboratories Ltd

FDC

85

Naftopidil 50mg + Dutasteride 0.5mg tablets

Intas Pharmaceuticals Ltd

FDC

86

Brinzolamide 1%w/v + Timolol 0.5%w/v eye drops

Sun Pharmaceuticals Industries Ltd

FDC

87

Artesunate 50mg/100mg/80mg + Piperaquine Phosphate 210mg/420mg/480mg tablet

IPCA Laboratories Ltd.

FDC

88

Rosuvastatin IP 10mg + Choline Fenofibrate DR 135mg capsules

intas pharmaceuticals

FDC

89

FDC of Azelastine Hydrochloride 137mg + Mometasone Furoate Monohydrate 50mcg Nasal Spray

Cipla Ltd

FDC

90

ART-123 (Recombinant Soluble Thrembomodulin alfa)

M/s. Asiatic Clinical Research Pvt Ltd.

GCT

91

Tenofovir Disoproxil Fumarate

M/s. Klinera Cooperation India Pvt Ltd.

GCT

92

CP-690,550

M/s. Pfizer

GCT

93

Octefibrin Lyophilised Powder

M/s. Max Neeman

GCT

94

Lixisenatide

M/s. Sanofi

GCT

95

Human-cl rh FVIII

M/s. Max Neeman

GCT

96

Fesoterodine Prolonged Tablet

M/s. Pfizer

GCT

97

Liraglutide SC Injection

M/s. Novo Nordisk

GCT

98

Vildagliptin Tablets

M/s. Novartis

GCT

99

Trastuzumab Conc Solution for Infusion

M/s. Roche

GCT

100

AMG145

M/s. Amgen

GCT

101

BEZ235

M/s. Novartis

GCT

102

Diclofenac Sodium  Gel

M/s. Amneal Pharma

GCT

103

Baricitinib

M/s. Eli Lilly

GCT

104

Baricitinib

M/s. Eli Lilly

GCT

105

Volasertib

M/s. Boehringer

GCT

106

Tenofovir Alafenamide

M/s. Klinera

GCT

107

Renal Denervation System

Medtronic India Pvt. Ltd.

Medical Device

 

 













Start date: 19/02/2015

End date: 01/12/2066 

Go back
Top page