This small-cap pharma company receives approval from USFDA

The tablets for which the company has got approval are used to treat hypertension in adults and paediatric patients.

Received Approval from USFDA

Granules India's Abbreviated New Drug Application (ANDA) for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg has been approved by the US Food & Drug Administration (USFDA). It is bioequivalent to Organon LLC's Cozaar Tablets, a reference-listed drug product (RLD). The US FDA has currently approved 54 ANDAs for granules (52 Final approvals and 2 tentative approvals).

For the treatment of hypertension in adults and paediatric patients 6 years of age and older, losartan potassium tablets are recommended since they reduce blood pressure. According to MAT Dec 2022, IQVIA/IMS Health, the current annual U.S. market for losartan potassium tablets is at $336 million.

Share price movement of Granules India Ltd

Scrip opened today at Rs 286.95 and made its day high at Rs 287.70. The 52-week high of the stock is Rs 381.25, whereas the 52-week low was Rs 227. Promoters hold 42.02%, whereas institutional and non-institutional holdings are 28.41% and 29.56%, respectively. Presently, the market cap of the company is Rs 6,997 crore.

Company profile

Granules India Ltd is a big, vertically integrated company that was established in 1991 and produces finished dosage, pharmaceutical formulation intermediates (PFI), and active pharmaceutical ingredients (API) (FD). The company has built up a significant market share in "the first line of defence" items including paracetamol, ibuprofen, metformin, methocarbamol, and guaifenesin throughout the years.

The company has established a dominant position in various generic pharmaceuticals thanks to its product-focused, vertically integrated business approach. It is widely present in drugs used as the "first line of defence," such as Paracetamol, Ibuprofen, Guaifenesin, and Metformin. Almost 60% of its income is exported to the US and Europe.