Indoco Remedies received the US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) for Glimepiride 1mg, 2mg and 4mg tablets. Glimepiride is indicated for type-2 diabetes mellitus treatment as an added therapy with diet and exercise to improve glycemic control in adults.
The market size of this product in the US is US$ 90 million and the API consumption is approximately 2000 kgs which is growing at 11.2 per cent.
“This is the first ANDA approval for solid dosages for Indoco and the company is fully integrated to manufacture this product. The product will be launched in the US in the month of May 2013,” informed Aditi Kare Panandikar, managing director, Indoco Remedies.
Four of the Indoco’s products are already available in the US market against the ANDAs filed and approved through partners. Additionally, Indoco has 37 ANDAs at various stages, out of which, 13 will be in the company’s name and the rest through its partners in the US market.