Sun Pharma Advanced Research Company Ltd expects to launch its novel dry-powder inhaler in India in the second quarter of financial year 2012.
The inhaler, delivering a drug combination that delivers equivalent efficacy at half the dose, has completed the third phase of clinical trials in India, the company recently told analysts. Phase-3 clinical trials involve testing the drug on large sample size of patients for safety and efficacy.
For the US, ‘pre-investigative new drug meetings' have been completed, and the investigative new drug filing is likely in financial year 2012, the company said.
The company is the demerged listed research arm of drug-maker Sun Pharma, and the management was sharing updates on its nine novel drug delivery system and four new chemical entity programmes.