@dishman
Dishman has been awarded manufacture of
SIRTURO® (bedaquiline) APT
Dishman Pharmaceuticals and Chemicals Limited (Dishman), a leading global manufacturer
of pharmaceutical active ingredients, announced today that it holds a license agreement
from Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson
& Johnson (Janssen) to produce the a:
{bedaquiline), a medicine used in the treatment of Mult
TB).
manufacturer of API with the USFOA, European Medicines Agency and several other Asian
regulatory authorities. Recently, Dishman has started supplying Janssen with the global
demand of this API.
‘Tuberculosis (7B) isa major public health concern in india with the World Health
Organization estimating there are more than 2.8 million cases of 78.1 articular, the
burden of MDR-T@ in inca, is among the most significant in the world with an estimated
64,000 cases’, and for those diagnosed with this deadly disease, fewer than helt are treated
successfully",
InJanuary 2015, SIRTURO" (bedaquiline) received approval from the Drugs Controller
General of india for use in adults (>18 years) as part of combination therapy of pulmonary
tuberculosis due to multidrug-resistant Mycobacterium tuberculosis when an effective
{treatment regimen cannot otherwise be provided. This approval provides for access to
bedaquiline under the Revised National TB Control Program through its Programmatic
Management of Drug Resistant TB framework in order to ensure appropriat
ishman Pharmaceuticals and Chemicals Limited
Reaisered Ofce: Bhodr-R Chambers, Sos Cross Roads, Novengpura,Akmedabed - 380 009 fais
Tek +91 (0) 79 26443083 / 26445807 Fax: +91 (0) 79 26420198 -
Email: dishman@dishmangroup.com Wab: wirn-dishmangroup.com
Government Recognised Export House
CIN NO L242306)1 p8apLCo06329@dishman
About Multidrug-Resistant Tuberculosis (MOR-TB)
MDR-TB i particularly complicated form of TB characterised by resistance to at least two
of the standard four-drug, ant-TB drugs." inadequately treated patients are likely to
increase selective pressure, allowing resistant bacteria to thrive and pose a significant
(ransmission risk to the general population. Without significant public health intervention,
MDR-TBis projected to infect more than two million people between 2011 and 2015."
Ministry of Health and Family Welfare. 78 indla 2024 Annual Status Report. Available at
ited tbcindia nlc in/odts/TB%20INDIA%202014,pcf. Accessed lanuary 2015,
| Mlestry of Heath and Family Welfare. TB India 2014~ Annual Status Roper hvstable st
itn dontbeindlanicin/pa(TB%2OINDI%202014 pdf. Accessed January 2015,
* WHO. Global Tuberculosis Report 2024. Available at
‘Bioufapos who ints /bst-eam/10685 /197094/1/8789241564809 eng pdlPuae1. Accessed January 2015
| WHO. Mutidrug-Resistant Tuberculosis, Online QUA, February 2012, Avelobie ae
brtnil/www.who.jnt/Festuces/aa/78/en/lodex hin. Accessed October 2014
|LWHO. Partners call for increased commitment to tackle MOR-TB. 23 March 2013, Available at
‘tipi wn. who,Int/mediacentre/news/releases/2011/TBdey 2110322/en/in Accessed October
2014
Dishman Pharmaceuticals and Chemicals Limited
Registered Office: Bhadr-Roj Chombers, Swostk Cross Roads, Nowrangpuro, Ahmedabad ~ 380 009 india
Tel: +91 (0) 79 26443053 / 26445807 Fax: +91 (0) 79 26420198 NN
Email: dshmen@dishmangroup.com Webs wiw.dishmangroup.com
Government Recognised Export House
IN NO 1242306) 983°1C006329