Matrix Laboratories, the Indian pharma company which has been in the news following its largest domestic acquisition of Strides Arcolab and an overseas acquisition of Docharma, has filed the highest number of drug master files with the US Food & Drug Administration in the second quarter of calendar year 2005.
Matrix has filed 12 DMFs out of the total 74 filings made by Indian companies during the period.
Dr Reddy's follows at the second slot with eight DMFs, another Hyderabad-based company -- Aurobindo Pharma -- filed six DMFs during the quarter.
Drug master files are confidential, proprietary assets that present to US Food and Drug A the formulae, processes, test methodology, and other data relevant to the manufacture of products used in the composition, packaging, processing of pharmaceuticals or biologics.
With 74 out of 213 DMFs filed with the US FDA, Indian companies accounted for 35 per cent new DMF filings during the period.
China, the emerging giant in the bulk drug business in Asia, has only 10 per cent of the filings, states the DMF list released by the FDA this week.
Industry analysts pointed out that the trend of more players filing for the same molecule has continued with nine molecules now seeing greater competition as against 12 in the first quarter of 2005. Five additional molecules now have more than five Indian players in competition.
"This trend has really caused concern within the industry as the pricing pressure will be intense in the US generics market, where Indian companies have bigger stake as the domestic market is shrinking in the post-patents period," said an industry analyst.
During the April-June quarter, the important filings were for metoprolol succinate (brand sales $1.2 billion) by Dr Reddy's, salmeterol (brand sales of $270 million) by Cipla and Natco and granisetron ($130 million) by Sun Pharma. The market for venlafaxine, ramipril, terbinafine, zolpidem and simvastatin has seen intense competition.]
A recent DMF update by J P Morgan shows that 70 per cent ($27 billion out of $39 billion) of the molecules coming off-patent in the next three years will see intense competition, as bulk is freely available.
This is in line with our expectation that 80 per cent of the products will see intense competition.
