Hetero Drugs gets US FDA nod for five APIs

Kailash Rajwadkar

Mumbai, Dec 3: Hyderabad-based Hetero Drugs has received the US Food and Drug Administration (FDA) approval for five active pharmaceutical ingredients (APIs) — omeprazole, tizanidine HCI, itraconazole, sertraline HCI and fosinopril sodium. The approval would enable the company to enter the regulated market in the US for the first time, Hetero Drugs director (business development) DM Shah said.

The above development reflects the company’s growth in other therapeutic segments which was otherwise predominantly in the generic arena of HIV/AIDS. The company has tied up with generic manufacturers in the US and expects to commence exports shortly, he added. Though Mr Shah declined to comment on the amount of business that may prop up, he said prices of the above APIs in the US market vary between five to ten times of those prevailing in the Indian market.

Omeprazole, which is currently under the 180-days exclusivity period in the US, is priced at over $600 out there while in India, prices hover around $150-200. Prices for sertraline HCI in India are $150 while the company is currently exporting to the regulated markets of Canada at $650. The price in the US is expected to be much higher, Mr Shah said.

For fosinopril sodium, Hetero lost to Teva of Israel for applying under para four for a non-infringing process and gaining the 180-days exclusivity by filing a few days earlier, Mr Shah revealed.