Pharma companies on DMF filing spree

59 Filings in Q3 represent around 37% of total global share

Domestic pharmaceutical companies "" led by Cipla, Matrix Laboratories, Aurobindo Pharma, Sun Pharmaceuticals, Lupin, Dr Reddy's and Glenmark Pharmaceuticals "" have filed 59 drug master files (DMFs) with the US Food and Drug Administration (FDA) in the third quarter of the current fiscal (October-December).

Collectively, they represent around 37 per cent of the total global filings during the period.

Indian pharma firms had filed 36 DMFs in the second quarter (July- September) of the fiscal year, accounting for about 38 per cent of the total global filings. India has been a leader in terms of DMF filings for the past few quarters.

DMF filing refers to the submission of data to the US FDA. This is followed by the abbreviated new drug application (ANDA) filing.

The data submitted by the companies are reviewed by the US FDA and only after the companies get an approval from the authority can their active pharmaceutical ingredients (API) appear in the drugs marketed in the US.

Through this route, an API manufacturer outside the US files an application for a product, which can later be used to support approval for any generic drug based on that particular API.

In 2003, the India pharma industry had filed 119 DMFs with the US FDA, accounting for one-third of the total global filings. India has the largest number of US FDA approved manufacturing plants outside the US.

Shekhar Bhirud, API business unit head of Glenmark Pharmaceuticals, told Business Standard: "Apart from establishing India as a leading low-cost API supplier for regulated markets, the growth in DMF filings will help accelerate formulation filings and favourably impact India's cost leadership in generic formulations as well."

Kamal Sharma, managing director of Lupin, said: "The large number of filings by Indian companies is a testimony to the research skills that the domestic pharma industry has acquired over the years. In the future, I see this trend strengthening as bigger pharmaceutical companies acquire a critical mass and the understanding about how to compete in the global markets."

The trend highlights the aggressive strategy of domestic pharma firms wanting to strengthen their product pipeline for the lucrative US market. With more mid-sized companies jumping into the fray, it will lead to a fierce competition. This may eventually lead to a fall in prices.

While Cipla, Matrix and Aurobindo are ahead in the December quarter race with six filings each; Sun Pharma filed five DMFs followed by DRL and Lupin filing four each. Zydus Cadilla, Glenmark Pharmaceuticals and Orchid Chemicals filed two DMF each and Ranbaxy filed only one DMF for the quarter.

The rest of the pack filed around 21. According to analysts, the cephalosporin segment witnessed many filings with Lupin targeting Cefdinir, the branded sales for which in the US is around $380 million and Cefprozil, the market for which is around $ 250 million in the US.

While Orchid Chemical filed for Ceftraixone ($700 million) and Cefotaxime, Aurobindo filed for Ceftraixone and Cefuroxime.

"With increased number of filings for Ceftriaxone, the market for this drug is expected to become more competitive after its patent expiry in June-2005," said a Mumbai-based analyst.

Lupin has already received the US FDA approval for Ceftriaxone. DRL made filings for Nateglinide and Cadila filed for Fluvastatin.