Granules India receives ANDA approval from USFDA

On Tuesday, Granules India announced that the US Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) it filed for Loratadine Tablets, 10 mg.

Granules India clarified that it intends to commercialize this product shortly. The approved ANDA by the US regulator is bio-equivalent to the Reference Listed Drug (RLD), Claritin Tablets 10 mg by Bayer Healthcare LLC.

Granules India Limited is a pharmaceutical company with a presence across the pharmaceutical manufacturing value chain, including active pharmaceutical ingredients (APIs), pharmaceutical formulation intermediaries (PFIs) and finished dosages (FDs). Its products include Paracetamol, Ibuprofen, Guaifenesin, and Metformin. The company operates a healthcare division, Granules Consumer Healthcare (GCH). Additionally, it has the access to over 10 APIs, as well as intermediates in therapeutic categories, such as anti-histaminic, antihypertensive, and anti-convulsant.

At 12 pm on Tuesday, the stock was trading at Rs 128 up by 0.78 per cent or Rs 0.90 per share. The 52-week high was recorded at Rs 135.85 and the 52-week low was recorded at Rs 83.70.