DMF Daddy – India tops USFDA list of drug master files

Data from Pharmexcil, a government body created for the promotion of Indian pharmaceutical exports shows that Indian companies made the most drug master filings or registrations of bulk drugs in the US (for all non-pharma types, bulk drugs are the key ingredients that lend the medicines their potency and are finished into capsules, and syrups).

India filed 2101  so-called ‘active’ DMFs (those currently in use) accounting for 29.25 per cent of all such filings. US companies with a 15.62 per cent share are a distant second. China places at number four with 9.23 per cent.

Among the Indian companies, Dr Reddy’s filed the most followed by Aurobindo and Cipla.

The US FDA, which opened an office in New Delhi early last year, wasn’t a moment too soon, it appears.

Global DMF (Type II active)*
Country No. of DMFs %    share
India 2,101 29.25%
USA 1,122 15.62%
Italy 732 10.19%
China 663 9.23%
Japan 328 4.57%
Germany 300 4.18%
Spain 264 3.68%
France 203 2.83%
Israel 174 2.42%
Switzerland 158 2.20%
Others 1138 15.84%
Total 7,183  

*as of September 30, 2009


4 thoughts on “DMF Daddy – India tops USFDA list of drug master files

  1. Its probably because of the huge profit margins they can reap in the western world rather than compete with the low cost producers here..


    1. That’s how it started. However, things are getting tough in the US for these companies. Unlike in India, where we pay artificial premiums for brands, in the US the cost of an off-patent drug can actually drop over 90 per cent when it loses patent protection (which is when Indian companies enter the market). Some analyst reports have showed that companies actually make better margins on branded drugs in India than they do on US generics.However, the US generics market is huge ($20bn plus) and cannot be ignored. Indian companies can make fat margins on specific products either by being the first to launch or staying in the market the longest.


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