Indoco Remedies has received the USFDA approval for its Abbreviated New Drug Application (ANDA) for Glimepiride 1mg, 2 mg and 4 mg 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 $90 million and the API consumption is approximately 2000 kg 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”, said Aditi Kare Panandikar, Managing Director, Indoco Remedies. Four of 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 partners in the US market.
EP News Bureau – Mumbai