Status of Import Permission (Form 45) of Vaccine from 2009 to 14th November 2013.
1
M/s. GC Chemie Pharma
Ltd., 5/C, Shri Laxmi Indl.
Estate, New LinkRoad,
Andheri (west), Mumbai.
M/s Synergy Diagnostics Pvt.
Ltd. 127/128, Laxmi Market,
Vartak Nagar, Thane.
M/s. Kiran Agencies,
A/40, Kalayanji Morarji,
Warehousing Co. Ltd. Prem
Industrial estate, Santa Savta
Marg, Mazgoan, MumbaiM/s Sanofi Pasteur India Pvt.
Ltd., D-2, Fourth Floor,
Southern Park, DDA
Commercial Centre, SaketDelhi
M/s Wyeth Ltd., Mumbai
Level 6 & 7, Platina, Plot No.
C-59, G-block, Bandra-Kurla
Complex, Bandra (East),
Mumbai-400098
2
3
4
5
6
7
M/s Nirlac Chemicals, 14th
floor, Nirmal Building,
241/242, Nariman Point,
Mumbai
M/s. MSD Pvt. Ltd.
7th floor, Tower-B, Vatika
Towers, Sector-54, Gurgaon
Name of Molecule
Approved
Influenza Vaccine Split
Indication
Date
For active Immunization against
susceptible Influenza.
Permission no. Import449/09,12th May, 2009
Rabies Vaccine (Freezed
Dried) (Vero Based)
For active immunization against Rabies,
both as prophylaxis and post bite cases.
Permission no. Import810/09, 21st Oct, 2009
Purified Rabies vaccine
(Vero cell Freezed dried)
For active immunization against Rabies for
Human use only.
Permission no. IMP205/10, 09th March, 2010
Influenza Inactivated, Split
Virion, Non-Adjuvanted
H1N1 vaccine.
For active immunization for H1N1
Pandemic Influenza
Permission no. IMP222/10, 12th March, 2010
Pneumococcal Saccharide
conjugate vaccine
(Adsorbed), 13 valent
Suspension
For active immunization for the prevention
of Pneumonia and invasive disease caused
by streptococcus pneumonia serotypes
1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F and
23F ( including species, meninggitis,
bacteraemia, pneumonia and acute otitis
media) in infants and children from 2
months to 5 years of age).
For active immunization against
poliomyelitis type I.
Permission no. IMP-2372010 dated 23th March
2010
Rota Teq is indicated for the prevention of
rotavirus gastroenteritis in infants and
children caused by th serotypes G1, G2,
Permission no. IMP339/10, 28th April, 2010
Oral Poliomyelitis (Type 1)
Vaccine Monovalent
Rotavirus Vaccine Live Oral
Pantavalent
Permission no. IMP1066/08, 12th April,
2010
1
Name of Firm
Page
S.No.
Purified Rabies vaccine
(Vero cell Freezed dried)
10
M/s GlaxoSmithKline
Pharmaceuticals Ltd.,
Mumbai
Synflorix [Pneumococcal
polysaccharide and NonTypeable Haemophilus
influenzae(NTHi) protein D
conjugate vaccine, adsorbed
(10 Pn-PD-DiT)]
11
M/s Novartis Healthcare Pvt.
Ltd., Sandoz House, Dr.
Annie Besant Road, Worli,
Mumbai.
M/s Sanofi Pasteur India Pvt.
Ltd., 54/A, Sir Mathuradas
Vasanji Road, Andheri East,
Mumabi-400093
Recombinant Hepatitis-B
Vaccine (Sci-B-Vac) from
9
12
13
M/s. Wockhardt Limited
Wockhardt Towers, Bandra
Kurla Complex, Bandra
(East), Mumbai 400051
Purified Rabies vaccine (vero For active immunization against Rabies for
cell ) for Human Use Freeze Human use only.
dried
Meningococcal A C Y and
W-135 Polysaccharide
Diphtheria Toxoid Conjugate
Active immunization of all infants and
children from 6 weeks up to 5 years of age
against diseases caused by Streptococcus
pneumonia serotypes 1, 4, 5, 6B, 7F, 9V,
14, 18C, 19F and 23f (including sepsis,
meningitis, pneumonia, bacteraemia and
acute otitis media) and against acute otitis
media caused by Non Typeable
Haemophilus influenzae.
For active immunization against Hepatitis
B virus.
For active immunization of healthy 2 years
to 55 years age group for prevention of
invasive meningococcal disease caused by
N.meningitides serogroups A, C, Y, and
W-135.
Freeze Dried Live Attenuated Active immunization against Hepatitis A
Hepatitis – A Vaccine
in adults & Children above one year age.
Permission no. IMP647/2010, 22nd Sep,
2010
Permission no. IMP94/2011, 22nd March
2011
Permission no. IMP102/2011, 20th Apr 2011
Permission no. IMP254/11, 2nd June 2011
Permission No. IMP134/2012 dated 12th
June 2012
Permission no. IMP 101/2013, dated; 25 Jun
2013
2
M/s Ranbaxy Laboratories
Ltd., Plot No. 90, Sector 32,
Gurgaon
M/s HLL Life Care
Ltd.(formerly Hindustan
Latex Limited), HILL
Bhavan, Pooojappura,
Thiruvananthapuram, Kerala
Page
8
G3 and G4 when administered as a 3 dose
series to infants between 6 to 32 weeks.
The first dose of Rota Teq should be
administered between 6 to 12 weeks of
age.
For active immunization against Rabies for
Human use only.
Influenza vaccine, surface
antigen, inactivated
For Active immunization against influenza Permission no. IMP(flu), especially in those who run an 139/2013, dated 26th Jun
increased risk of associated complications. 2013.
Quinvaxem (DTwP-Hib-Hep
B vaccine)
Paediatric combination vaccine against Permission No. IMPdiphtheria, tetanus, pertussis, hepatitis B 189/2013 dated:30th Aug
and disease caused by Haemophilus 2013
influenzae type b.
3
M/s Novartis Healthcare Pvt.
Ltd, Vaccine Division
division, 501, Shree Amba
Shanti Chambers, Andheri
Kurla Road, Andheri-East,
Mumbai-400059
15. Novartis Healthcare Pvt.
Ltd., Vaccines Division,
Andheri east, Mumbai400 059
Page
14
Status of Bulk Import permission (Form 45 A) of Vaccine
1.
1252/Panacea/1
2-BD
2.
1265/GSK/11BD (VIRAL)
Name of Firm
Imported from
M/s Panacea Biotec ltd.,
New Delhi.
M/s P.T. BioFarma, Indonesia
M/s GlaxoSmithKline Asia
Pvt Ltd., A-10/1, M.I.D.C.
Ambad-Pathardi Phara,
Ambad, Nashik-422010
M/s
GlaxoSmithKline
Biologicals S.A.,
Rue de l’Institit 89,
B-1330 Rixensart,
Belgium
Name of Molecule
Approved
Diphtheria Toxoid
concentrate, Tetanus
Toxoid concentrate &
whole cell Pertussis
concentrate
Purified Hepatitis B
surface antigen bulk
vaccine
Date
Bulk -105/2013 dated
29.04.2013
Permission no. BULK68/2013 dated 09 Sep
2013
4
F.No.
Page
S.No.