Pharma major Ind-Swift Laboratories, which has a strong basket of over 40 products across 16 therapeutic segments, has got the US FDA nod for two more DMFs temozolomide and telmisartan. Besides commercially supplying four molecules to the US, the company has hitherto filed 20 DMFs with the US FDA, of which all have been approved.
N R Munjal, vice-chairman and managing director of Ind-Swift Laboratories, said: “The company has high regulatory standards where its facilities are already approved by US FDA/MHRA/TGA /COS/KFDA/Who-GMP, and with this approval for temozolomide, an anti-neoplastic drug with market size of US$ 700 million, and telmisartan, a drug for hypertension with market size worth $1.6 billion, the company is aiming at marketing these products once they go off patent.”
The company’s subsidiary in the US, which has been operational since 2005, is playing a significant role in boosting the company’s business in the US market as it has forged key contracts with leading US generic companies.
The company has so far filed 302 DMFs with various regulatory authorities, including 4 DMFs filed in Japan. Also, 124 patents have been filed, of which one has been granted for cardiovascular drug. Munjal added that the company aims at filing 4-5 DMFs per year in US in the next 3-4 years.
Ind Swift has eight synthetic labs and state-of-the-art research and development facility manned by over 100 scientists. With a clear focus on positioning itself as a primary supplier of specialized APIs to regulated markets, Ind Swift has undertaken various globalisation initiatives by entering into regulated markets (US, Europe, Japan, Australia & Canada). Besides, it has registered its blockbusters products in various non-regulated & soft regulated countries, filed DMFs, invested heavily in R&D, developed its IPR cell & upgraded manufacturing facilities with increased capacities to cater to the increased global demand for the company’s products.
Ind Swift cloaked a turnover of Rs. 722.99 crore during nine months of the financial year 2010-11 as against Rs. 579.84 crore in the corresponding nine months of 2009-10. It earned a net profit of Rs. 61.22 crore in nine months of FY 2010-11 as against that of Rs. 37.21 crore earned in 2009-10.