Granules India gets USFDA approval for hypertension drug; share price gains

Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension to lower blood pressure and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.

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Granules India share price up marginally in the early trade on October 3 after the company received USFDA approval for tablets for the treatment of hypertension.

At 09:23 hrs Granules India was quoting at Rs 355.75, up Rs 1.00, or 0.28 percent on the BSE.

The US Food & Drug Administration (USFDA) has approved its abbreviated new drug application (ANDA) for Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg.

The tablets are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Hyzaar Tablets of OrganonLLC.

Losartan potassium and hydrochlorothiazide tablets are indicated for the treatment of hypertension to lower blood pressure and to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy.

The company has now a total of 60 ANDA approvals from the USFDA (58 Final approvals and 2 tentative approvals).

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In September, in their inaugural review by MSCI, the company was awarded a “BB” in MSCI ESG rating with an Industry Adjusted Score of 4.1. The score for the pharmaceutical industry spans a minimum of 1.9 to a maximum of 6.3 among 225 Pharmaceutical companies covered by MSCI.

According to the rating results, Granules India Limited’s Climate Commitment is aligned with an MSCI implied Temperature Rise of 1.7°C, categorizing the company under the 2°C-Aligned bucket.

MSCI is a leading provider of critical decision support tools and services for the global investment community. MSCI ESG Ratings aim to measure a company’s management of financially relevant ESG risks and opportunities.

In August, the pharma company received an accreditation certificate from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan and compliance approval from ANVISA, the Brazilian health regulator.

The accreditation certificate, which is required by foreign drug manufacturers to export drugs to Japan, was awarded for the company’s Jeedimetla facility in Telangana.

Also, the company received approval from the Brazilian regulator for compliance with the guidelines of good manufacturing practices for its Bonthapally facility in Telangana. The plant makes active pharmaceutical ingredients (APIs).

In Q1FY24, the company reported a 3.3 percent year-on-year (YoY) decline in revenue at Rs 985.5 crore. Net profit dropped 62.4 percent YoY to Rs 47.9 crore.

Granules India is engaged in the production of pharmaceutical raw materials. The company specialises in active pharma ingredients, pharmaceutical formulation intermediates as well as finished dosages.