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Last updated on : 12/04/2016
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Approval

CT APPROVAL 2015

Monthwise status of CT NOC granted by CDSCO during the period January 2015 

S.NO

MONTHS

NUMBER OF CT APPROVALS GRANTED

01

January 

8

02

February

8

03

March

2

04

April

1

CT NOC 2015

S.No

Drug

Firm

Category

1

Mifepristone & Misoprosto

 

Dr. Lakbir Dhaliwal

GCT

2

Mifepristone & Misoprosto

M/s Fortis Memorial Research Institute

GCT

3

Pasirotide

M/s Novartis

GCT

4

Pasirotide

M/s Novartis

GCT

5

LCI699

M/s Novartis

GCT

6

LY2963016

M/s Eli Lilly

GCT

7

Insulin Detemir

M/s Novo Nordisk

GCT

8

NNCO-195-0092

M/s Novo Nordisk

GCT

9

Labetalol , nifedipine, methyldopa

Dr. Suchita Mundel

GCT

10

Labetalol , nifedipine, methyldopa

Dr. Vaishali Khedikar

GCT

11

DS5565

M/s INC Research

GCT

12

Tiotropium + Olodaterol

M/s Boheringer

GCT

13

Ioniazide

Dr. Ramesh Bhosale

GCT

14

QGE031

M/s Novartis

GCT

15

Ticagrelor

M/s Astra Zeneca

GCT

16 Paclitaxel and Carboplatin Dr. Shyam kishore Shrivastava GCT
17 Masitinib Maya Clinicals GCT
18 FIB Grifols Max Neeman GCT
19 Dabigatran Etexilate Boehringer GCT
20 Dabigatran & Omeprazole St. John's Research Institute GCT
21 Gemcitabine + Capecitabine Dr. Shailesh V Shrikhande GCT
22 Rituximab Pfizer GCT
23 Masitinib Maya Clinicals GCT
24 Masitinib Maya Clinicals GCT
25 LEE011 Novartis Novartis GCT
26 Bococizumab Pfizer GCT
27 Bococizumab Pfizer GCT
28

Amphotericin B lipid emulsion 20mg/kg

Bharat Serums and vaccine  Ltd

SND

29

Botulinum toxin type A

Allergen India pvt ltd

SND

30

Tacrolimus lipid suspension for injection 5mg/vial

Intas Pharmaceuticals Pvt. Ltd

SND

31

Prednisone MR Tablet 5 mg

Sun Pharma Laboratories Limited

SND

32

Tacrolimus  ointment 0.1%w/v (Export purpose)

Intas D.No 18864 dt 12-06-2015

SND

33

Lacosamide injection 10mg/mL

SUN

SND

34

Cabazitaxel Lipid Suspension for injection 50mg/vial

Intas 

SND

35

Nanosomal Paclitaxel Lipid Suspension for Injection 30mg/vial and 60mg/vial

Intas 

SND

36

Permethrin 5% Cream

Cliantha Research LTd

SND

37

Glycol Lubricant Eye Drops 0.6% (Systane Balance)

M/s Alcon Labs

SND

38

Methylcobalamin nasal spray 250µg/puff

M/s Troikaa pharmaceuticals

SND

39

Tacrolimus ointment 0.03%

Intas Pharmaceuticals Ltd

SND
40 Tacrolimus ointment 0.1% Intas Pharmaceuticals Ltd SND
41 Nepafenac 0.3%ophthalmic suspension M/s Cliantha Research Ltd SND
42 Tacrolimus lipid tablet 1mg Intas Pharmaceuticals Ltd SND
43 Clindamycine and Benzaclin Cliantha GCT
44 Dabigatran Boehringer Boehringer GCT
45 Multi Octave (Anti Viral Drugs) Dr. N Kumarswamy GCT
46 Octafibrin Max Neeman GCT
47 DE-109 Excel Life Scinece GCT
48 LEE011 Novartis GCT
49 LEE011 Maya Clinicals GCT
50 QVA149 Novartis GCT
51 Biasp and Insulin Aspartate Novo Nordisk GCT
52 Canagliflozine J & J GCT
53 Methyl Prednisolone George Clinicals GCT
54 Ranibizumab Novartis GCT
55 Moroctocog Alfa Pfizer GCT
56 LCZ696 Novartis GCT
57 Bepotastine Besilate Tablet M/s Lupin Limited New Drug
58 Saroglitazar 2/4mg Tablets M/s Cadila Healthcare Ltd. Investigational New Drug
59 Saroglitazar Tablets M/s Cadila Healthcare Ltd. Investigational New Drug
60 Endoxifen M/s Intas Pharma Investigational New Drug
61 Evogliptin M/s Alkem Laboratories Investigational New Drug
62 Apixaban M/s BMS India Pvt. Ltd. New Drug
63 Rifampicin Dr. P. V. Dave Institutional
64 Mirabegron M/s Lupin Pharma New Drug
65 Tamoxifen Citrate 20 mg Dr. Avanthi Gudipadi Institutional
66 Oral Glycrol Dr. Ramesh Kumar Institutional
67 Metformin Dr. T. S. Ganesan Institutional
68 VSL#3 Dr. Arun Bansal Institutional
69 Abiraterone Acetate Tablet 250 mg M/s J & J New Drug
70 Ulipristal M/s Ajanta Pharma New Drug
71 Cabazitaxel Dr. Kumar Prabhash Institutional
72 Hydroxy-progesterone Dr. R A Badwe Institutional
73 Arterolane Maleate + Piperaquine Phosphate M/s Ranbaxy Labs Investigational New Drug
74 Treosulpan M/s Emcure Pharmaceuticals New Drug
75 Arterolane Maleate + Piperaquine Phosphate M/s Sun Pharma Investigational New Drug
76 Goat Lung Surfactant Dr. Ramesh Agarwal Institutional
77 Fentanyl & Midazolam Dr. Smita Prakash Institutional
78 Norethisterone CR Tablet 10mg M/s Synokem Pharma SND
79 Progesterone SR Tablet 200mg/300mg/400mg M/s Synokem Pharma SND
80 Paclitaxel Oral liquid 50mg/ml M/s Cadila SND
81 Ulinastatin injection 50000IU/100000IU M/s Lupin SND
82 Heparin Injection 5000IU/ml M/s Troikaa SND
83 Hydroxychloroquine sulphate tablet 400mg M/s IPCA SND
84 Prucalopride Tablet M/s Torrent New Drug
85 Alcaftadine Eye Drops M/s Ajanta Investigational New Drug
86 Bivalirudin Dr. Suruchi Hasija Investigational New Drug
87 Ulipristal M/s Intas Investigational New Drug
88 Verapamil Dr. Soumya Swaminathan Investigational New Drug
89 Ulinastatin Injection M/s Bharat Serum New Drug
90 Degarelix for Injection M/s Ferring Pharma New Drug
91 Acotiamide Tablet 100mg M/s Hetero Labs New Drug
92 Cadexomer Iodine M/s Virchow Biotech New Drug
93 Mirabegron Tablet M/s MSN New Drug
94 CPL-2009-0031 M/s Cadila Pharmaceuticals Investigational New Drug
95 ZYAN1 M/s Cadila Healthcare Investigational New Drug
96 Pegaspargase Injection M/s Gennova Biopharmaceuticals New Drug
97 Polyethylene Glycol + Propylene Glycol M/s. Alcon Laboratories India Pvt. Ltd. FDC
98 Dapoxetine + Sildenafil
M/s. Hetero Labs Ltd.
FDC
99 Losartan Potassium + Amlodipine + Hydrochlorothiazide M/s. Micro Labs Ltd FDC
100 S-Amlodipine + Losartan Potassium M/s. Emcure Pharmaceuticals Ltd. FDC
101
 
M/s. Sigma-Tau ndia Pvt. Ltd. FDC
102 Brinzolamide IP + Brimonidine Tartrate IP + Benzalkonium Chloride IP (as preservative) M/s. Torrent Pharmaceuticals Ltd. FDC
103
 
M/s. Unimed Technologies Ltd. FDC
104
 
M/s. Sun Pharma Laboratories Ltd. FDC
105
 
M/s. Sun Pharma Laboratories Ltd. FDC
106 Capecitabine + Cyclophosphamide M/s. Sun Pharma Laboratories Ltd. FDC
107 Minoxidil + Finasteride M/s. Sanofi-Synthelabo (India) Pvt. Ltd. FDC
108
 
M/s. Intas Pharmaceuticals Ltd. FDC
109 Linaclotide M/s Axis Clinical Ltd GCT
110 LCZ696 M/s Novartis GCT
111 Pregabalin M/s Pfizer GCT
112 Dydrogestorne M/s Abbott GCT
113 Secukinumab M/s Novartis GCT
114 GENA-05 M/s Max Neeman GCT
115 Roxadustat M/s AstraZeneca GCT
116 Roxadustat M/s AstraZeneca GCT
117 FG-3019 M/s Excel Life Sci. GCT
118 QGE031 M/s Novartis GCT
119 QGE031 M/s Novartis GCT
120 CTP10 M/s PPD GCT
121 Alirocumab M/s Sanofi GCT

 













Start date: 12/03/2015

End date: 01/12/2066 

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